Paclitaxel, Trastuzumab, and Pertuzumab with or without Atezolizumab in Treating Patients with Metastatic Breast Cancer

Status: Active

Description

This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body (metastatic). Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab is a form of “targeted therapy” because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body’s immune system. Monoclonal antibodies, such as pertuzumab, may interfere with the ability of cancer cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab may kill more tumor cells.

Eligibility Criteria

Inclusion Criteria

  • The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease or metastatic disease confirmed as described below; eligible patients include those with either: * De novo metastatic disease presenting without prior history of HER2-positive breast cancer: ** Diagnosis should have been made from a biopsy of a metastatic disease site, but biopsy from the breast primary or involved regional lymph nodes is acceptable if biopsy of the metastatic sites was thought to carry excessive risk for the patient * Locally recurrent or metastatic disease following prior therapy for early breast cancer: ** Diagnosis must have been made from the biopsy of the locally recurrent or metastatic disease ** There must be an interval of >= 6 months between completion of neoadjuvant/adjuvant HER2-targeted therapy and documentation of locally recurrent or metastatic HER2-positive disease by biopsy
  • Patients must have measurable disease based on RECIST 1.1, as determined by the site, to be eligible
  • The tumor specimen obtained at the time of diagnosis of locally recurrent or metastatic disease must have been determined to be HER2-positive based on central testing according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines (Wolff 2018); HER2 status will initially be assessed using a Food and Drug Administration (FDA)-cleared IHC assay; positive is defined as IHC 3+ staining intensity; if HER2 IHC results are equivocal (2+), then HER2 status will be determined using a FDA-cleared HER2 in situ hybridization (ISH) test according to ASCO/CAP guidelines; sites can send biopsy specimens for central testing which have been determined to be HER2-positive or initially equivocal by either IHC or ISH on local testing
  • The tumor specimen obtained at the time of diagnosis used for HER2 testing must also have central testing for PD-L1 status; patients will be eligible irrespective of PD-L1 testing result including PD-L1 indeterminant
  • The tumor specimen obtained at the time of diagnosis used for HER2 and PD-L1 testing should also have central testing for estrogen receptor (ER) and progesterone receptor (PgR) according to current ASCO/CAP guideline recommendations for hormone receptor testing; patients with < 1% ER and PgR staining by IHC will be classified as negative; if sufficient material for central confirmation of ER and PgR is unavailable, local testing results for ER and PgR may be used for eligibility
  • Localized palliative radiation therapy is allowed for symptom management if completed >= 14 days prior to randomization
  • Patients must have imaging of the chest/abdomen/pelvis, preferably with a computed tomography (CT) scan, and a bone scan within 4 weeks prior to randomization; (NOTE: if a patient is unable to receive CT contrast, a magnetic resonance imaging [MRI] of the abdomen/pelvis and non-contrast chest CT should be performed; positron emission tomography/computed tomography [PET/CT] is not an acceptable alternative)
  • MRI of the brain (or contrast CT scan of the brain if patients are unable to undergo MRI) must be obtained in patients with symptoms suggesting possible central nervous system (CNS) metastatic disease; neuroimaging is recommended but not required in asymptomatic patients
  • Absolute neutrophil count (ANC) must be >= 1200/mm^3 (within 14 days prior to randomization)
  • Platelet count must be >= 100,000/mm^3 (within 14 days prior to randomization)
  • Hemoglobin must be >= 8 g/dL (within 14 days prior to randomization)
  • Total bilirubin must be =< 1.5 x upper limit of normal (ULN) for the lab or direct bilirubin =< ULN for patients with bilirubin levels > 1.5 x ULN (within 14 days prior to randomization)
  • Aspartate aminotransferase (AST) and alanine aminotransaminase (ALT) must be =< 2.5 x ULN for the lab or =< 5 x ULN for patients with liver metastases (within 14 days prior to randomization)
  • Serum creatinine =< 1.5 x ULN or measured or calculated creatinine clearance >= 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels > 1.5 x ULN for the lab (within 14 days prior to randomization)
  • Patients not receiving anti-coagulant therapy must have prothrombin time (PT) and international normalized ratio (INR) =< 1.5 x ULN within 14 days prior to randomization; for laboratories that do not report an ULN for the INR assay, use =< 1.5 as the value for the ULN; patients receiving anti-coagulants should have a baseline INR assessed, but the value does not affect eligibility
  • A serum thyroid-stimulating hormone (TSH) and AM (morning) cortisol must be obtained within 14 days prior to randomization to obtain a baseline value and be within normal limits for the local laboratory
  • Left ventricular ejection fraction (LVEF) assessment must be performed within 6 weeks prior to randomization; (LVEF assessment performed by echocardiogram is preferred; however, multigated acquisition scan (MUGA) scan may be substituted based on institutional preferences); the LVEF must be >= 55% regardless of the cardiac imaging facility's lower limit of normal
  • Administration of atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality; women of child-bearing potential and men must agree to use adequate contraception (non-hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of atezolizumab/placebo and 7 months after the last dose of trastuzumab and pertuzumab; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately

Exclusion Criteria

  • Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions: * Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met: ** Evaluable or measurable disease outside the CNS ** No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm) ** No history of intracranial hemorrhage or spinal cord hemorrhage ** No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted ** No neurosurgical resection or brain biopsy within 28 days prior to randomization * Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following: ** Radiographic demonstration of improvement upon the completion of CNS directed therapy and no evidence of interim progression between the completion of CNS directed therapy and the screening radiographic study ** No stereotactic radiation or whole-brain radiation within 4 weeks prior to randomization ** Screening CNS radiographic study 4 weeks from completion of radiotherapy and 2 weeks from discontinuation of corticosteroids
  • Known leptomeningeal carcinomatosis
  • Patients with metastatic disease limited to the CNS
  • History of systemic anti-cancer therapy (e.g., chemotherapy, targeted therapy) for metastatic breast cancer (MBC) with the exception of administration of trastuzumab or lapatinib concurrently with radiation therapy for brain metastases; toxicities related to lapatinib should be =< grade 1, per the CTCAE version (v)5.0 and must have been completed at least 2 weeks prior to randomization
  • History of exposure to cumulative doses of doxorubicin greater than 360 mg per square meter of body-surface area or its equivalent
  • Prior treatment with mTOR inhibitors or CDK 4/6 inhibitors in combination with endocrine therapy for treatment of metastatic disease
  • Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
  • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization
  • Uncontrolled hypertension defined as sustained systolic blood pressure (BP) > 150 mmHg or diastolic BP > 90 mmHg; (patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria)
  • History of asymptomatic LVEF decline to < 40% during or after prior HER2-targeted therapy
  • Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens; this includes but is not confined to: * Active cardiac disease ** Angina pectoris that requires the current use of anti-anginal medication; ** Ventricular arrhythmias except for benign premature ventricular contractions; ** Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; ** Conduction abnormality requiring a pacemaker; ** Valvular disease with documented compromise in cardiac function; or ** Symptomatic pericarditis * History of cardiac disease ** Prior myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function; ** History of documented congestive heart failure (CHF) defined as symptomatic heart failure with an LVEF < 40%; or ** Documented cardiomyopathy
  • Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the CTCAE v 5.0
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or other recombinant antibodies
  • Known allergy or hypersensitivity to the components of the atezolizumab formulation or to any of the study drugs or excipients, (e.g., Cremophor EL)
  • History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis * Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible * Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible * Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: ** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations ** Rash must cover less than 10% of body surface area (BSA) ** Disease is well controlled at baseline and only requiring low-potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%) ** No acute exacerbations of underlying conditions within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
  • Treatment with systemic immunosuppressive medications (including but not limited to interferons, IL-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to randomization
  • Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti−tumor necrosis [anti-TNF] factor agents) within 14 days prior to randomization or anticipation of need for systemic immunosuppressive medications during the study; Note: Intranasal and inhaled corticosteroids or systemic corticosteroids at doses that do not exceed 10 mg/day of prednisone or an equivalent corticosteroid are allowed
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks prior to randomization
  • Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B surface antigen (HBsAg) test at screening; patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study if active HBV infection is ruled out on the basis of HBV deoxyribonucleic acid (DNA) viral load per local guidelines
  • Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test at screening confirmed by a polymerase chain reaction (PCR) positive for HCV ribonucleic acid (RNA)
  • Patients with clinically active tuberculosis
  • Patients known to be human immunodeficiency virus (HIV) positive are eligible if they meet the following criteria within 4 weeks prior to randomization: * A stable regimen of highly active anti-retroviral therapy (HAART) and; * No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections; and * A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests
  • Severe infection within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Prior allogeneic stem cell or solid organ transplantation
  • Symptomatic peripheral ischemia
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis or >= grade 1 pulmonary fibrosis, per the CTCAE v5.0, on screening chest CT scan
  • Administration of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such vaccine will be required during the study * Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist) within 4 weeks prior to randomization, during treatment or within 5 months following the last dose of atezolizumab/placebo
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results
  • Pregnancy or lactation at the time of randomization or intention to become pregnant during the study; (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 72 hours prior to randomization)
  • Use of any investigational product within 4 weeks prior to randomization

Locations & Contacts

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 205-934-0220
Email: tmyrick@uab.edu

Alaska

Anchorage
Katmai Oncology Group
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org

Arizona

Goodyear
CTCA at Western Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 623-207-3000

California

Anaheim
Kaiser Permanente-Anaheim
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Antioch
Kaiser Permanente-Deer Valley Medical Center
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Baldwin Park
Kaiser Permanente-Baldwin Park
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Bellflower
Kaiser Permanente-Bellflower
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Berkeley
Alta Bates Summit Medical Center-Herrick Campus
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Costa Mesa
UC Irvine Health Cancer Center-Newport
Status: Active
Contact: Site Public Contact
Phone: 877-827-8839
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-826-4673
Email: becomingapatient@coh.org
Fontana
Kaiser Permanente-Fontana
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Fremont
Kaiser Permanente-Fremont
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Palo Alto Medical Foundation-Fremont
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Fresno
Kaiser Permanente-Fresno
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Harbor City
Kaiser Permanente - Harbor City
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Irvine
Kaiser Permanente-Irvine
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Los Angeles
Kaiser Permanente Los Angeles Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Kaiser Permanente-Cadillac
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Modesto
Kaiser Permanente-Modesto
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Memorial Medical Center
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Mountain View
Palo Alto Medical Foundation-Camino Division
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Oakland
Kaiser Permanente-Oakland
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-827-8839
Email: ucstudy@uci.edu
Palo Alto
Palo Alto Medical Foundation Health Care
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Panorama City
Kaiser Permanente - Panorama City
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Richmond
Kaiser Permanente-Richmond
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Riverside
Kaiser Permanente-Riverside
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Roseville
Kaiser Permanente-Roseville
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sacramento
Kaiser Permanente Downtown Commons
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: kpoct@kp.org
Kaiser Permanente-South Sacramento
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sutter Medical Center Sacramento
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
San Diego
Kaiser Permanente-San Diego Zion
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
San Francisco
California Pacific Medical Center-Pacific Campus
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Kaiser Permanente-San Francisco
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Jose
Kaiser Permanente-Santa Teresa-San Jose
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Leandro
Kaiser Permanente San Leandro
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Marcos
Kaiser Permanente-San Marcos
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
San Rafael
Kaiser San Rafael-Gallinas
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Santa Cruz
Palo Alto Medical Foundation-Santa Cruz
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Santa Rosa
Kaiser Permanente-Santa Rosa
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
South San Francisco
Kaiser Permanente-South San Francisco
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Stockton
Kaiser Permanente-Stockton
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sunnyvale
Palo Alto Medical Foundation-Sunnyvale
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Vacaville
Kaiser Permanente Medical Center-Vacaville
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Vallejo
Kaiser Permanente-Vallejo
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Walnut Creek
Kaiser Permanente-Walnut Creek
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Woodland Hills
Kaiser Permanente-Woodland Hills
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org

Colorado

Aurora
University of Colorado Hospital
Status: Active
Contact: Site Public Contact
Phone: 720-848-0650
Colorado Springs
Memorial Hospital North
Status: Active
Contact: Site Public Contact
Phone: 719-364-6700
UCHealth Memorial Hospital Central
Status: Active
Contact: Site Public Contact
Phone: 719-365-2406
Denver
Cancer Center of Colorado at Sloan's Lake
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
SCL Health Saint Joseph Hospital
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Fort Collins
Cancer Care and Hematology-Fort Collins
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Poudre Valley Hospital
Status: Active
Contact: Site Public Contact
Phone: 970-297-6150
Greeley
UCHealth Greeley Hospital
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Highlands Ranch
UCHealth Highlands Ranch Hospital
Status: Active
Contact: Site Public Contact
Phone: 720-848-0650
Lafayette
Good Samaritan Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-673-1622
Loveland
Medical Center of the Rockies
Status: Active
Contact: Site Public Contact
Phone: 970-203-7083
Wheat Ridge
SCL Health Lutheran Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org

Connecticut

Danbury
Danbury Hospital
Status: Active
Contact: Site Public Contact
Phone: 203-739-8074
Norwalk
Norwalk Hospital
Status: Active
Contact: Site Public Contact
Phone: 203-852-2996
Email: jennifer.long@norwalkhealth.org

Delaware

Newark
Helen F Graham Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Medical Oncology Hematology Consultants PA
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Rehoboth Beach
Beebe Health Campus
Status: Active
Contact: Site Public Contact
Phone: 302-645-3100
Email: Dmiskin@Beebehealthcare.org

Florida

Fort Lauderdale
Broward Health Medical Center
Status: Active
Contact: Site Public Contact
Phone: 954-355-5346
Orlando
UF Cancer Center at Orlando Health
Status: Active
Contact: Site Public Contact
Phone: 321-841-7246
Email: CancerClinicalTrials@orlandohealth.com
Pensacola
Sacred Heart Hospital
Status: Active
Contact: Site Public Contact
Phone: 850-416-4611
Email: eebrou@ascension.org

Georgia

Atlanta
Northside Hospital
Status: Active
Contact: Site Public Contact
Phone: 404-303-3355
Email: ClinicalTrials@northside.com
Piedmont Hospital
Status: Active
Contact: Site Public Contact
Phone: 404-425-7943
Email: ORS@piedmont.org
Fayetteville
Piedmont Fayette Hospital
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org

Hawaii

Aiea
Hawaii Cancer Care - Savio
Status: Active
Contact: Site Public Contact
Phone: 808-539-2273
Honolulu
Hawaii Cancer Care Inc-POB II
Status: Active
Contact: Site Public Contact
Phone: 808-524-6115
Hawaii Oncology Inc-Kuakini
Status: Active
Contact: Site Public Contact
Phone: 808-531-8521
Hawaii Oncology Inc-POB I
Status: Active
Contact: Site Public Contact
Phone: 808-532-0315
Queen's Medical Center
Status: Active
Contact: Site Public Contact
Phone: 808-545-8548

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Nampa
Saint Alphonsus Medical Center-Nampa
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org

Illinois

Aurora
Rush - Copley Medical Center
Status: Active
Contact: Site Public Contact
Phone: 630-978-6212
Email: Cancer.Research@rushcopley.com
Bloomington
Illinois CancerCare-Bloomington
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Canton
Illinois CancerCare-Canton
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Carthage
Illinois CancerCare-Carthage
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Chicago
University of Illinois
Status: Active
Contact: Site Public Contact
Phone: 312-355-3046
Danville
Carle on Vermilion
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Effingham
Carle Physician Group-Effingham
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Crossroads Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Eureka
Illinois CancerCare-Eureka
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Galesburg
Illinois CancerCare-Galesburg
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Harvey
Ingalls Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 708-915-4673
Email: clinicaltrials@ingalls.org
Joliet
Joliet Oncology-Hematology Associates Limited
Status: Active
Contact: Site Public Contact
Phone: 815-730-3098
Email: maureenc@jolietoncology.com
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Macomb
Illinois CancerCare-Macomb
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Pekin
Illinois CancerCare-Pekin
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peoria
Illinois CancerCare-Peoria
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peru
Illinois CancerCare-Peru
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Princeton
Illinois CancerCare-Princeton
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Springfield
Southern Illinois University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: Active
Contact: Site Public Contact
Phone: 800-444-7541
Urbana
Carle Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Zion
Midwestern Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org

Indiana

Munster
The Community Hospital
Status: Active
Contact: Site Public Contact
Phone: 219-836-3349
South Bend
Memorial Hospital of South Bend
Status: Active
Contact: Site Public Contact
Phone: 800-284-7370

Iowa

Ames
Mary Greeley Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
McFarland Clinic PC - Ames
Status: Active
Contact: Site Public Contact
Phone: 515-239-4734
Email: ksoder@mcfarlandclinic.com
Boone
McFarland Clinic PC-Boone
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
Cedar Rapids
Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 319-365-4673
Oncology Associates at Mercy Medical Center
Status: Active
Contact: Site Public Contact
Phone: 319-363-2690
Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Mercy Cancer Center-West Lakes
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Des Moines
Broadlawns Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-282-2200
Iowa Methodist Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Status: Active
Contact: Site Public Contact
Phone: 515-282-2921
Medical Oncology and Hematology Associates-Laurel
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Mercy Medical Center - Des Moines
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
Trinity Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-574-8302
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-237-1225
Jefferson
McFarland Clinic PC-Jefferson
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
Marshalltown
McFarland Clinic PC-Marshalltown
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132

Kansas

Kansas City
University of Kansas Cancer Center-West
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Overland Park
University of Kansas Cancer Center-Overland Park
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu

Kentucky

Lexington
Baptist Health Lexington
Status: Active
Contact: Site Public Contact
Phone: 859-260-6425
Saint Joseph Hospital East
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Louisville
Baptist Health Louisville
Status: Active
Contact: Site Public Contact
Phone: 502-897-8592
Email: Cbcresearch@bhsi.com

Louisiana

Baton Rouge
Louisiana Hematology Oncology Associates LLC
Status: Active
Contact: Site Public Contact
Phone: 225-215-1353
Email: clinicalresearch@marybird.com
LSU Health Baton Rouge-North Clinic
Status: Active
Contact: Site Public Contact
Phone: 225-215-1353
Email: clinicalresearch@marybird.com
Mary Bird Perkins Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 225-215-1353
Email: clinicalresearch@marybird.com
Our Lady of the Lake Physicians Group - Medical Oncology
Status: Active
Contact: Site Public Contact
Phone: 225-215-1353
Email: clinicalresearch@marybird.com
Woman's Hospital
Status: Active
Contact: Site Public Contact
Phone: 225-215-1353
Email: Clinicalreserach@marybird.com
Covington
Northshore Oncology Associates-Covington
Status: Active
Contact: Site Public Contact
Phone: 225-215-1353
Email: clinicalresearch@marybird.com
Houma
Oncology Center of The South Incorporated
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 225-215-1353
Email: clinicalresearch@marybird.com

Maine

Biddeford
MaineHealth / SMHC Cancer Care and Blood Disorders-Biddeford
Status: Active
Contact: Site Public Contact
Email: LLemire@mmc.org
Brewer
Lafayette Family Cancer Center-EMMC
Status: Active
Contact: Site Public Contact
Phone: 800-987-3005
Sanford
MaineHealth / SMHC Cancer Care and Blood Disorders-Sanford
Status: Active
Contact: Site Public Contact
Email: LLemire@mmc.org

Maryland

Easton
University of Maryland Shore Medical Center at Easton
Status: Active
Contact: Site Public Contact
Phone: 410-822-1000
Email: Christina.weisenborn@umm.edu

Massachusetts

Burlington
Lahey Hospital and Medical Center
Status: Active
Contact: Site Public Contact
Phone: 781-744-3421
Email: cancerclinicaltrials@lahey.org

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
University of Michigan Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-865-1125
Bay City
McLaren Cancer Institute-Bay City
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Brighton
IHA Hematology Oncology Consultants-Brighton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Brighton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Canton
IHA Hematology Oncology Consultants-Canton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Canton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Caro
Caro Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Chelsea
IHA Hematology Oncology Consultants-Chelsea
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Chelsea
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Clarkston
McLaren Cancer Institute-Clarkston
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Detroit
Ascension Saint John Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Henry Ford Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Wayne State University / Karmanos Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
East China
Great Lakes Cancer Management Specialists-Doctors Park
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Farmington Hills
Weisberg Cancer Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Flint
Genesee Cancer and Blood Disease Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Genesee Hematology Oncology PC
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Genesys Hurley Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
McLaren Cancer Institute-Flint
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Grand Rapids
Spectrum Health at Butterworth Campus
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Grosse Pointe Woods
Academic Hematology Oncology Specialists
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Michigan Breast Specialists-Grosse Pointe Woods
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Jackson
Allegiance Health
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Kalamazoo
West Michigan Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Lansing
McLaren-Greater Lansing
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Mid-Michigan Physicians-Lansing
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Sparrow Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Lapeer
McLaren Cancer Institute-Lapeer Region
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Livonia
Hope Cancer Clinic
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Mary Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Macomb Township
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Michigan Breast Specialists-Macomb Township
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Marlette
Saint Mary's Oncology / Hematology Associates of Marlette
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Mount Clemens
McLaren Cancer Institute-Macomb
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Mount Pleasant
McLaren Cancer Institute-Central Michigan
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Petoskey
McLaren Cancer Institute-Northern Michigan
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Port Huron
McLaren-Port Huron
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Rochester Hills
Great Lakes Cancer Management Specialists-Rochester Hills
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saginaw
Ascension Saint Mary's Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Oncology Hematology Associates of Saginaw Valley PC
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Southfield
Ascension Providence Hospitals - Southfield
Status: Active
Contact: Site Public Contact
Phone: 248-849-5332
Email: karen.fife@ascension.org
Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Tawas City
Ascension Saint Joseph Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Warren
Great Lakes Cancer Management Specialists-Macomb Professional Building
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Michigan Breast Specialists-Warren
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint John Macomb-Oakland Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
West Branch
Saint Mary's Oncology / Hematology Associates of West Branch
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Ypsilanti
IHA Hematology Oncology Consultants-Ann Arbor
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org

Minnesota

Bemidji
Sanford Joe Lueken Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 218-333-5000
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Deer River
Essentia Health - Deer River Clinic
Status: Active
Contact: Site Public Contact
Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org
Minneapolis
Hennepin County Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Rochester
Mayo Clinic
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Saint Cloud
Coborn Cancer Center at Saint Cloud Hospital
Status: Active
Contact: Site Public Contact
Phone: 877-229-4907
Email: coborncancercenter@centracare.com
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint Paul
United Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Mississippi

Gulfport
Gulfport Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 504-210-3539
Email: emede1@lsuhsc.edu

Missouri

Bonne Terre
Parkland Health Center-Bonne Terre
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569
Cape Girardeau
Saint Francis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Columbia
University of Missouri - Ellis Fischel
Status: Active
Contact: Site Public Contact
Phone: 573-882-7440
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Jefferson City
Capital Region Southwest Campus
Status: Active
Contact: Site Public Contact
Phone: 573-632-4814
Email: swooden@mail.crmc.org
Kansas City
The University of Kansas Cancer Center-North
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Lee's Summit
The University of Kansas Cancer Center-Lee's Summit
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
North Kansas City
University of Kansas Cancer Center at North Kansas City Hospital
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Saint Louis
Missouri Baptist Medical Center
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569
Siteman Cancer Center at Christian Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Siteman Cancer Center-South County
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Washington University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569
Sullivan
Missouri Baptist Sullivan Hospital
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569

Montana

Bozeman
Bozeman Deaconess Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Nebraska

Omaha
Alegent Health Bergan Mercy Medical Center
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Nebraska Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 402-354-5144

Nevada

Las Vegas
Comprehensive Cancer Centers of Nevada
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
OptumCare Cancer Care at Fort Apache
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
OptumCare Cancer Care at MountainView
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
OptumCare Cancer Care at Oakey
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org

New Hampshire

Concord
New Hampshire Oncology Hematology PA-Concord
Status: Active
Contact: Site Public Contact
Phone: 603-224-2556
Hooksett
New Hampshire Oncology Hematology PA-Hooksett
Status: Active
Contact: Site Public Contact
Phone: 800-339-6484
Lebanon
Dartmouth Hitchcock Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

New Jersey

Paramus
The Valley Hospital-Luckow Pavilion
Status: Active
Contact: Site Public Contact
Phone: 201-634-5792

New Mexico

Albuquerque
New Mexico Oncology Hematology Consultants
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 505-272-0530
Email: CLee@nmcca.org
Presbyterian Kaseman Hospital
Status: Active
Contact: Site Public Contact
Phone: 505-559-6113
Email: WBurman@phs.org
University of New Mexico Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 505-925-0366
Email: LByatt@nmcca.org
Las Cruces
Memorial Medical Center - Las Cruces
Status: Active
Contact: Site Public Contact
Phone: 575-556-6545
Email: Kim.Hoffman@lpnt.net
Rio Rancho
Presbyterian Rust Medical Center / Jorgensen Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 505-559-6113
Email: WBurman@phs.org

New York

Auburn
Hematology Oncology Associates of Central New York-Auburn
Status: Active
Contact: Site Public Contact
Phone: 315-472-7504
Bronx
Montefiore Medical Center - Moses Campus
Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Montefiore Medical Center-Einstein Campus
Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Montefiore Medical Center-Weiler Hospital
Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Buffalo
Roswell Park Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 800-767-9355
Email: askroswell@roswellpark.org
East Syracuse
Hematology Oncology Associates of Central New York-East Syracuse
Status: Active
Contact: Site Public Contact
Phone: 315-472-7504
Rochester
University of Rochester
Status: Active
Contact: Site Public Contact
Phone: 585-275-5830
Stony Brook
Stony Brook University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-862-2215
Syracuse
Hematology Oncology Associates of Central New York-Onondaga Hill
Status: Active
Contact: Site Public Contact
Phone: 315-472-7504
State University of New York Upstate Medical University
Status: Active
Contact: Site Public Contact
Phone: 315-464-5476

North Carolina

Asheboro
Randolph Hospital
Status: Active
Contact: Site Public Contact
Phone: 336-832-0836
Email: vivian.sheidler@conehealth.com
Asheville
Hope Women's Cancer Centers-Asheville
Status: Active
Contact: Site Public Contact
Phone: 828-213-2539
Email: Karen.Smith3@HCAHealthcare.com
Mission Hospital
Status: Active
Contact: Site Public Contact
Phone: 828-213-2539
Email: Karen.Smith3@HCAHealthcare.com
Burlington
Cone Health Cancer Center at Alamance Regional
Status: Active
Contact: Site Public Contact
Phone: 336-538-7725
Email: kaye.shoffner@conehealth.com
Greensboro
Cone Health Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 336-832-0821
Email: vivian.sheidler@conehealth.com
Hendersonville
Margaret R Pardee Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 828-696-4716
Email: karen.morris@unchealth.unc.edu
Kenansville
Vidant Oncology-Kenansville
Status: Active
Contact: Site Public Contact
Phone: 252-559-2201
Email: Carla.Zimmerman@vidanthealth.com
Kinston
Vidant Oncology-Kinston
Status: Active
Contact: Site Public Contact
Phone: 252-559-2201
Email: Carla.Zimmerman@vidanthealth.com
Pinehurst
FirstHealth of the Carolinas-Moore Regional Hospital
Status: Active
Contact: Site Public Contact
Phone: 910-715-3500
Email: jcwilliams@firsthealth.org
Richlands
Vidant Oncology-Richlands
Status: Active
Contact: Site Public Contact
Phone: 252-559-2201
Email: Carla.Zimmerman@vidanthealth.com
Rocky Mount
Nash General Hospital
Status: Active
Contact: Site Public Contact
Phone: 252-962-8947

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Fargo
Sanford Broadway Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Sanford Roger Maris Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 701-234-6161
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Ohio

Beachwood
UHHS-Chagrin Highlands Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Belpre
Strecker Cancer Center-Belpre
Status: Active
Contact: Site Public Contact
Phone: 800-523-3977
Email: sheree@columbusccop.org
Canton
Mercy Medical Center
Status: Active
Contact: Site Public Contact
Phone: 888-293-4673
Chardon
Geauga Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Chillicothe
Adena Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 877-779-7585
Email: sheree@columbusccop.org
Cleveland
Case Western Reserve University
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Cleveland Clinic Foundation
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
MetroHealth Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 216-778-8526
Email: dstrater@metrohealth.org
Columbus
Columbus Oncology and Hematology Associates Inc
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Doctors Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-566-3275
Email: sheree@columbusccop.org
Grant Medical Center
Status: Active
Contact: Site Public Contact
Phone: 614-566-4475
Email: sheree@columbusccop.org
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-293-5066
Email: Jamesline@osumc.edu
The Mark H Zangmeister Center
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Delaware
Delaware Health Center-Grady Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 740-615-0227
Email: sheree@columbusccop.org
Elyria
Mercy Cancer Center-Elyria
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Mansfield
OhioHealth Mansfield Hospital
Status: Active
Contact: Site Public Contact
Phone: 419-526-8018
Email: sheree@columbusccop.org
Marietta
Marietta Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-523-3977
Email: sheree@columbusccop.org
Marion
OhioHealth Marion General Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Mentor
UH Seidman Cancer Center at Lake Health Mentor Campus
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Middleburg Heights
UH Seidman Cancer Center at Southwest General Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Newark
Licking Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 740-348-4000
Email: sheree@columbusccop.org
Parma
University Hospitals Parma Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Portsmouth
Southern Ohio Medical Center
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Ravenna
University Hospitals Portage Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Sandusky
UH Seidman Cancer Center at Firelands Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Sylvania
ProMedica Flower Hospital
Status: Active
Contact: Site Public Contact
Phone: 419-824-1842
Wadsworth
University Hospitals Sharon Health Center
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Westlake
UH Seidman Cancer Center at Saint John Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
UHHS-Westlake Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Zanesville
Genesis Healthcare System Cancer Care Center
Status: Active
Contact: Site Public Contact
Phone: 740-454-5232
Email: sheree@columbusccop.org

Oklahoma

Lawton
Cancer Centers of Southwest Oklahoma Research
Status: Active
Contact: Site Public Contact
Phone: 877-231-4440
Oklahoma City
Integris Cancer Institute of Oklahoma
Status: Active
Contact: Site Public Contact
Phone: 405-773-6613
University of Oklahoma Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu
Tulsa
Cancer Treatment Centers of America
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Oklahoma Cancer Specialists and Research Institute-Tulsa
Status: Active
Contact: Site Public Contact
Phone: 918-505-3200

Oregon

Clackamas
Providence Oncology and Hematology Care Southeast
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Newberg
Providence Newberg Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Portland
Providence Portland Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org

Pennsylvania

Bethlehem
Saint Luke's University Hospital-Bethlehem Campus
Status: Active
Contact: Site Public Contact
Phone: 484-503-4151
Bryn Mawr
Bryn Mawr Hospital
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
Collegeville
Main Line Health Center-Collegeville
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
Exton
Main Line Health Center-Exton
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
Harrisburg
UPMC Pinnacle Cancer Center / Community Osteopathic Campus
Status: Active
Contact: Site Public Contact
Phone: 717-724-6765
Email: klitchfield@PINNACLEHEALTH.org
Media
Riddle Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
Paoli
Paoli Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Contact: Site Public Contact
Phone: 412-647-8073
Sayre
Guthrie Medical Group PC-Robert Packer Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-836-0388
West Reading
Reading Hospital
Status: Active
Contact: Site Public Contact
Phone: 610-988-9323
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
Williamsport
UPMC Susquehanna
Status: Active
Contact: Site Public Contact
Phone: 800-598-4282
Willow Grove
Abington Memorial Hospital-Asplundh Cancer Pavilion
Status: Active
Contact: Site Public Contact
Phone: 215-481-2402
Wynnewood
Lankenau Medical Center
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org

South Carolina

Charleston
Medical University of South Carolina
Status: Active
Contact: Site Public Contact
Phone: 843-792-9321
Email: hcc-clinical-trials@musc.edu
West Columbia
Lexington Medical Center
Status: Active
Contact: Site Public Contact
Phone: 803-936-8050

South Dakota

Sioux Falls
Avera Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 888-634-7268
Email: oncregulatory@avera.org
Sanford Cancer Center Oncology Clinic
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicTrialsSF@sanfordhealth.org
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicalTrialsSF@SanfordHealth.org

Tennessee

Cookeville
Cookeville Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 931-783-2714
Kingsport
Regional Cancer Center at Indian Path Community Hospital
Status: Active
Contact: Site Public Contact
Phone: 423-578-8538
Email: Justin.reynolds@balladhealth.org

Texas

San Antonio
University of Texas Health Science Center at San Antonio
Status: Active
Contact: Site Public Contact
Phone: 210-450-3800
Email: phoresearchoffice@uthscsa.edu

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu

Virginia

Bristol
Wellmont Medical Associates-Bristol
Status: Active
Contact: Site Public Contact
Phone: 423-578-8538
Email: justin.reynolds@wellmont.org
Fairfax
Inova Schar Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 703-720-5210
Email: Stephanie.VanBebber@inova.org
Mechanicsville
Bon Secours Memorial Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 804-893-8611
Email: Melissa_Godsey@bshsi.org
Midlothian
Bon Secours Saint Francis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 804-893-8611
Email: Melissa_Godsey@bshsi.org
Norton
Southwest VA Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 423-578-8538
Email: justin.reynolds@wellmont.org
Richmond
Bon Secours Saint Mary's Hospital
Status: Active
Contact: Site Public Contact
Phone: 804-893-8611
Email: Melissa_Godsey@bshsi.org
Virginia Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 804-287-3000
Email: david.trent@comcast.net
Virginia Commonwealth University / Massey Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 804-628-1914
Email: klcampbell@vcu.edu
South Hill
VCU Community Memorial Health Center
Status: Active
Contact: Site Public Contact
Phone: 434-774-2442
Email: sherman.baker@vcuhealth.org
Winchester
Shenandoah Oncology PC
Status: Active
Contact: Site Public Contact
Phone: 540-662-1108
Email: William.Houck@usoncology.com

Washington

Auburn
MultiCare Auburn Medical Center
Status: Active
Contact: Site Public Contact
Phone: 253-887-9333
Email: research@multicare.org
Edmonds
Swedish Cancer Institute-Edmonds
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Gig Harbor
MultiCare Gig Harbor Medical Park
Status: Active
Contact: Site Public Contact
Phone: 253-403-2394
Email: research@multicare.org
Issaquah
Swedish Cancer Institute-Issaquah
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Puyallup
MultiCare Good Samaritan Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-351-7955
Email: research@multicare.org
Seattle
Swedish Medical Center-First Hill
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Spokane
Rockwood Cancer Treatment Center-DHEC-Downtown
Status: Active
Contact: Site Public Contact
Phone: 509-724-4454
Email: apope@rockwoodclinic.com
Rockwood North Cancer Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 509-724-4454
Email: apope@rockwoodclinic.com
Spokane Valley
Rockwood Clinic Cancer Treatment Center-Valley
Status: Active
Contact: Site Public Contact
Phone: 509-724-4454
Email: apope@rockwoodclinic.com
Tacoma
MultiCare Tacoma General Hospital
Status: Active
Contact: Site Public Contact
Phone: 253-403-3229
Email: research@multicare.org

West Virginia

Bridgeport
United Hospital Center
Status: Active
Contact: Site Public Contact
Phone: 304-293-7374
Email: cancertrialsinfo@hsc.wvu.edu
Charleston
West Virginia University Charleston Division
Status: Active
Contact: Site Public Contact
Phone: 304-388-9944
Morgantown
West Virginia University Healthcare
Status: Active
Contact: Site Public Contact
Phone: 304-293-7374
Email: cancertrialsinfo@hsc.wvu.edu

Wisconsin

Antigo
Langlade Hospital and Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 715-623-9869
Email: Juli.Alford@aspirus.org
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Marinette
Saint Vincent Hospital Cancer Center at Marinette
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Mukwonago
ProHealth D N Greenwald Center
Status: Active
Contact: Site Public Contact
Email: research.institute@phci.org
Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 262-928-7878
Waukesha
ProHealth Waukesha Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 262-928-7632
UW Cancer Center at ProHealth Care
Status: Active
Contact: Site Public Contact
Phone: 262-928-5539
Email: Chanda.miller@phci.org
Wausau
Aspirus Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-405-6866
Wisconsin Rapids
Aspirus UW Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 715-422-7718

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will improve the progression-free survival (PFS), as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo in patients with newly documented HER2-positive measurable metastatic breast cancer.

SECONDARY OBJECTIVES:

I. To determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will improve the overall survival (OS) relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo.

II. To determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will improve the overall objective response (OR), assessed by investigator using RECIST 1.1 criteria, relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo.

III. To determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will improve PFS, OR, and/or duration of objective response assessed by retrospective blinded central review using RECIST 1.1 criteria, relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo.

IV. To determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will decrease the incidence of subsequent brain metastases in patients without known brain metastases at study entry relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo.

V. To determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will contribute to increased patient-reported fatigue in comparison to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo.

VI. To determine the utility of PD-L1 immunohistochemistry (IHC) staining as a predictive and prognostic biomarker associated with clinical response, as assessed by investigator using RECIST 1.1 criteria, to atezolizumab in combination with paclitaxel, trastuzumab, and pertuzumab.

VII. To determine the immune-related toxicity profile of the two treatment regimens.

VIII. To determine the cardiac safety profile of the two treatment regimens.

EXPLORATORY OBJECTIVES:

I. To determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will improve the progression-free survival and overall objective response, assessed by investigator using immune-modified RECIST (iRECIST) criteria, relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo.

II. To identify potential biomarkers that can predict benefit from the addition of atezolizumab in patients with newly documented HER2-positive measurable metastatic breast cancer treated with a regimen of paclitaxel, pertuzumab, and trastuzumab, and placebo.

III. To explore the toxicity profile of the two treatment regimens using patient-reported symptomatic adverse events in addition to standard adverse event reports.

IV. To determine the feasibility and added value of frequent assessment of toxicity using Patient Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) with electronic(e)PRO reporting.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive pertuzumab intravenously (IV) over 30-60 minutes on days 1 and 22, trastuzumab IV over 30-90 minutes on days 1 and 22, paclitaxel IV over 60 minutes on days 1, 8, 15, 22, 29, and 36, and atezolizumab IV over 60 minutes on days 1 and 22. Cycles for pertuzumab, trastuzumab and atezolizumab repeat every 6 weeks and treatment with paclitaxel repeats every 6 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive additional 3 cycles of paclitaxel in the absence of progression at the investigator's discretion.

ARM II: Patients receive pertuzumab, trastuzumab, and paclitaxel as in Arm I. Patients also receive placebo IV over 60 minutes on days 1 and 22. Cycles for pertuzumab, trastuzumab, and placebo repeat every 6 weeks and treatment with paclitaxel repeats every 6 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive additional 3 cycles of paclitaxel in the absence of progression at the investigator's discretion.

After completion of study treatment, patients are followed up every 3 months for 3 years and then every 6 months for 4 years.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
NRG Oncology

Principal Investigator
Charles Edward Geyer

Trial IDs

Primary ID NRG-BR004
Secondary IDs NCI-2017-01119
Clinicaltrials.gov ID NCT03199885