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Testing the Ability to Decrease Chemotherapy in Patients with HER2-Positive Breast Cancer Who Have No Remaining Cancer at Surgery after Limited Pre-operative Chemotherapy and HER2-Targeted Therapy

Trial Status: Active

This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. 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 tumor cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body’s immune system. Pertuzumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.

Inclusion Criteria

  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patient must have histologically confirmed HER2-positive primary invasive breast carcinoma, as defined by the 2018 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) HER2 testing guideline focused update (Wolff et al, 2018) and determined by local testing
  • Patients hormone receptor (ER and progesterone receptor [PR]) status must be known and will be determined by local testing. Patients with either hormone receptor –positive or hormone receptor- negative HER2-positive breast cancer are eligible
  • Patients must have clinical stage II and IIIa (T2-3/N0-2/M0) at diagnosis * Patients without nodal involvement (cN0) are eligible if T size >= 2.0 cm * Patients with nodal involvement (cN1-2) are eligible if T size >= 1.5 cm
  • Patient must be willing and able (i.e., have no contraindication) to receive standard adjuvant therapy, consisting of HER2-directed therapy, radiation (if indicated) and endocrine therapy (if ER+) if achieving pCR at surgery
  • Patient with two separate invasive breast cancers (ipsilateral or bilateral) are eligible if both cancers are HER2-positive and at least one meets protocol eligibility (i.e., >= 1.5 cm if cN1-2; >= 2 cm if cN0) (neither tumor can be T4 or N3)
  • Patients with multifocal or multicentric disease are eligible as long as all tumor foci that were tested for HER2 status at the local institution are HER2-positive, and at least one tumor focus meets eligibility criteria
  • Patients must not have impaired decision-making capacity
  • Patients with a history of other non-breast malignancies are eligible if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy * Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, and localized papillary or follicular thyroid cancer who have completed recommended treatment including surgery. Patients with any other cancers within the last 5 years are ineligible
  • Patents must have a left ventricular ejection fraction (LVEF) within normal institutional parameters (or > 50%)
  • Patients must have a bilateral mammogram and diagnostic breast ultrasound (with or without breast magnetic resonance imaging [MRI]) performed at screening (within 42 days of registration)
  • Baseline imaging of the ipsilateral axilla by ultrasound is mandatory. For subjects with axillary lymph node(s) suspicious on clinical exam or imaging, patient must be willing to have a needle aspiration or core biopsy to determine the presence of metastatic disease in the lymph nodes. A clip must be placed in the involved axillary lymph node
  • Women of childbearing potential and sexually active males must use accepted and effective method(s) of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 7 months after the last dose of study treatment
  • Patient must be willing and able to sign informed consent
  • Leukocytes >= 3,000/mcL (obtained =< 28 days prior to protocol registration)
  • Absolute neutrophil count >= 1,500/mcL (obtained =< 28 days prior to protocol registration)
  • Platelets >= 100,000/mcL (obtained =< 28 days prior to protocol registration)
  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (obtained =< 28 days prior to protocol registration)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained =< 28 days prior to protocol registration)
  • Creatinine =< 1.5 x institutional ULN (obtained =< 28 days prior to protocol registration)
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

Exclusion Criteria

  • Patient must not have a history of any prior (ipsilateral or contralateral) invasive breast cancer * One exception: a patient with a history of T1N0 triple negative breast cancer diagnosed more than 10 years earlier, who remains disease free is eligible
  • Patient must not have prior ipsilateral ductal breast carcinoma in situ (DCIS). Patients with prior lobular breast carcinoma in situ (LCIS), atypical hyperplasia, other high risk benign lesions or contralateral DCIS (without evidence of microinvasion) are eligible * NOTE: Patients currently receiving endocrine therapy for prior contralateral DCIS are eligible
  • Patient must not have stage IV (metastatic) breast cancer * Staging studies (computed tomography [CT] chest/abdomen/pelvis and a bone scan or positron emission tomography [PET]-CT scan) are required for stage III disease or those with abnormal baseline liver function tests (LFTs), symptoms (e.g. new bone pain) or abnormal physical exam findings (National Comprehensive Cancer Network [NCCN] guidelines version [V]1.2019)
  • Patient must not have T4 and/or N3 disease, including inflammatory breast cancer
  • Patient must not have any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy
  • Patients must not have > grade 1 peripheral neuropathy of any etiology
  • Patient must not have a concurrent serious medical condition that would preclude completion of study therapy. For example, uncontrolled hypertension (systolic > 180 mm Hg and/or diastolic > 100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to registration, unstable angina, congestive heart failure (CHF) or serious cardiac arrhythmia requiring medication and other concurrent serious diseases that may interfere with planned treatment
  • Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. Patients must also not expect to conceive from the time of registration, while on study treatment, and until at least 7 months after the last dose of study treatment. All females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy * A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 205-934-0220

Alaska

Anchorage
Alaska Breast Care and Surgery LLC
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Alaska Oncology and Hematology LLC
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Alaska Women's Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Associates in Radiation Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Oncology Centre
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Radiation Therapy Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Katmai Oncology Group
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Providence Alaska Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871

Arizona

Kingman
Kingman Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact

Arkansas

Ft. Smith
Mercy Hospital Fort Smith
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-378-9373
Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

California

Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
Status: ACTIVE
Contact: Site Public Contact
Phone: 916-851-2283
PCR Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Auburn
Sutter Auburn Faith Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Sutter Cancer Centers Radiation Oncology Services-Auburn
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Berkeley
Alta Bates Summit Medical Center-Herrick Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 818-847-4793
Burlingame
Mills-Peninsula Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Cameron Park
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Castro Valley
Eden Hospital Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Davis
Sutter Davis Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Fremont
Palo Alto Medical Foundation-Fremont
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Modesto
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Mountain View
Palo Alto Medical Foundation-Camino Division
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Palo Alto Medical Foundation-Gynecologic Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Palm Springs
Desert Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 760-416-4730
Palo Alto
Palo Alto Medical Foundation Health Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Roseville
Sutter Cancer Centers Radiation Oncology Services-Roseville
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Sutter Roseville Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Sacramento
Sutter Medical Center Sacramento
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
San Francisco
California Pacific Medical Center-Pacific Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Santa Cruz
Palo Alto Medical Foundation-Santa Cruz
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Santa Maria
Mission Hope Medical Oncology - Santa Maria
Status: ACTIVE
Contact: Site Public Contact
Phone: 916-851-2283
Santa Rosa
Sutter Pacific Medical Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Sunnyvale
Palo Alto Medical Foundation-Sunnyvale
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Vacaville
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Vallejo
Sutter Solano Medical Center / Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686

Colorado

Colorado Springs
Penrose-Saint Francis Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Rocky Mountain Cancer Centers-Penrose
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Denver
Porter Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Durango
Mercy Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Southwest Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Lakewood
Saint Anthony Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Littleton
Littleton Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Longmont
Longmont United Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Rocky Mountain Cancer Centers-Longmont
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Parker
Parker Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Pueblo
Saint Mary Corwin Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Connecticut

Stamford
Stamford Hospital / Bennett Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 203-323-8944

Delaware

Frankford
Beebe South Coastal Health Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-645-3100
Lewes
Beebe Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-645-3770
Newark
Christiana Care Health System-Christiana Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Delaware Clinical and Laboratory Physicians PA
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Helen F Graham Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Medical Oncology Hematology Consultants PA
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Rehoboth Beach
Beebe Health Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-645-3100
Seaford
Nanticoke Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-645-3100
Wilmington
Christiana Care Health System-Wilmington Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450

District of Columbia

Washington
Sibley Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 202-243-2373

Florida

Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-243-2647
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-243-2647
Gainesville
University of Florida Health Science Center - Gainesville
Status: ACTIVE
Contact: Site Public Contact
Phone: 352-273-8010
Jacksonville
Mayo Clinic in Florida
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Miami
UM Sylvester Comprehensive Cancer Center at Kendall
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-243-2647
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-243-2647
Plantation
UM Sylvester Comprehensive Cancer Center at Plantation
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-243-2647

Georgia

Atlanta
Northside Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-303-3355
Duluth
Northside Hospital - Duluth
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-303-3355
Lawrenceville
Northside Hospital - Gwinnett
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-303-3355
Snellville
Suburban Hematology Oncology Associates - Snellville
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-303-3355
Thomasville
Lewis Hall Singletary Oncology Center
Status: ACTIVE
Contact: Site Public Contact

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Mountain States Tumor Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Coeur D'Alene
Kootenai Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Emmett
Walter Knox Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Fruitland
Saint Luke's Mountain States Tumor Institute - Fruitland
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-8059
Meridian
Idaho Urologic Institute-Meridian
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Mountain States Tumor Institute - Meridian
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-8059
Nampa
Saint Alphonsus Medical Center-Nampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Mountain States Tumor Institute - Nampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-8059
Post Falls
Kootenai Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Sandpoint
Kootenai Cancer Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Twin Falls
Saint Luke's Mountain States Tumor Institute-Twin Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-8059

Illinois

Aurora
Rush - Copley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-978-6212
Bloomington
Illinois CancerCare-Bloomington
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Canton
Illinois CancerCare-Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Carbondale
Memorial Hospital of Carbondale
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-457-5200
Carterville
SIH Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-985-3333
Carthage
Illinois CancerCare-Carthage
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Centralia
Centralia Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Chicago
Rush University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-942-5498
Swedish Covenant Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-878-8200
Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Dixon
Illinois CancerCare-Dixon
Status: ACTIVE
Contact: Site Public Contact
Phone: 815-285-7800
Effingham
Carle Physician Group-Effingham
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Eureka
Illinois CancerCare-Eureka
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Galesburg
Illinois CancerCare-Galesburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Western Illinois Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-344-2831
Joliet
Joliet Oncology-Hematology Associates Limited
Status: ACTIVE
Contact: Site Public Contact
Phone: 815-730-3098
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Macomb
Illinois CancerCare-Macomb
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Mount Vernon
Good Samaritan Regional Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-242-4600
O'Fallon
Cancer Care Center of O'Fallon
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Pekin
Illinois CancerCare-Pekin
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peoria
Illinois CancerCare-Peoria
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Methodist Medical Center of Illinois
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peru
Illinois CancerCare-Peru
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Valley Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 815-664-4141
Princeton
Illinois CancerCare-Princeton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Silvis
Genesis Cancer Center - Silvis
Status: ACTIVE
Contact: Site Public Contact
Phone: 563-421-1908
Springfield
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-788-3528
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
Swansea
Southwest Illinois Health Services LLP
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-236-1000
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
The Carle Foundation Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Yorkville
Rush-Copley Healthcare Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-978-6212

Indiana

Carmel
IU Health North Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 317-278-5632
Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 317-278-5632
Richmond
Reid Health
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900

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
Boone
McFarland Clinic PC-Boone
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Mercy Cancer Center-West Lakes
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Council Bluffs
Alegent Health Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Creston
Greater Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Davenport
Genesis Cancer Care Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 563-421-1908
Genesis Medical Center - East Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 563-421-1908
Iowa Cancer Specialists
Status: ACTIVE
Contact: Site Public Contact
Phone: 563-421-1908
Des Moines
Broadlawns Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2200
Iowa Lutheran Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-241-8704
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
Mercy Medical Center - Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
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
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
West Des Moines
Mercy Medical Center-West Lakes
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Methodist West Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-343-1000

Kentucky

Bardstown
Flaget Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Corbin
Commonwealth Cancer Center-Corbin
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Lexington
Saint Joseph Hospital East
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Saint Joseph Radiation Oncology Resource Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
London
Saint Joseph London
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Louisville
Jewish Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Jewish Hospital Medical Center Northeast
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Saints Mary and Elizabeth Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Shepherdsville
Jewish Hospital Medical Center South
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Louisiana

New Orleans
Louisiana State University Health Science Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-210-3539
University Medical Center New Orleans
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-210-3539

Maine

Augusta
Harold Alfond Center for Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-626-4855
Belfast
Waldo County General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-338-2500
Biddeford
MaineHealth / SMHC Cancer Care and Blood Disorders-Biddeford
Status: ACTIVE
Contact: Site Public Contact
Brewer
Lafayette Family Cancer Center-EMMC
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-987-3005
Kennebunk
Maine Center for Cancer Medicine-Kennebunk
Status: ACTIVE
Contact: Site Public Contact
Rockport
Penobscot Bay Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-396-8670
Sanford
MaineHealth / SMHC Cancer Care and Blood Disorders-Sanford
Status: ACTIVE
Contact: Site Public Contact
Scarborough
Maine Center for Cancer Medicine-Scarborough
Status: ACTIVE
Contact: Site Public Contact
Maine Medical Center- Scarborough Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-396-8090
South Portland
Maine Medical Partners - South Portland
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-396-8670
Topsham
Maine Center for Cancer Medicine-Topsham
Status: ACTIVE
Contact: Site Public Contact

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-955-8804

Massachusetts

Beverly
Beverly Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 978-922-3000ext2405
Burlington
Lahey Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 781-744-3421
Gloucester
Addison Gilbert Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 978-283-4000ext559
Springfield
Baystate Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 413-794-3565
Winchester
Winchester Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-823-5923
Worcester
UMass Memorial Medical Center - University Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 508-856-3216

Michigan

Novi
Ascension Providence Hospitals - Novi
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-849-5332
Southfield
Ascension Providence Hospitals - Southfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-849-5332

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015

Mississippi

Jackson
University of Mississippi Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 601-815-6700
Pascagoula
Singing River Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 228-809-5292

Missouri

Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7058
Branson
Cox Cancer Center Branson
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Southeast Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-651-5550
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Farmington
Parkland Health Center - Farmington
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Jefferson City
Capital Region Southwest Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-632-4814
Joplin
Freeman Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-347-4030
Mercy Hospital Joplin
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-556-3074
Rolla
Delbert Day Cancer Institute at PCRMC
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-8776
Mercy Clinic-Rolla-Cancer and Hematology
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-6379
Saint Joseph
Heartland Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 816-271-7937
Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7066
Mercy Hospital South
Status: ACTIVE
Contact: Site Public Contact
Missouri Baptist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Saint Louis Cancer and Breast Institute-South City
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-353-1870
Siteman Cancer Center at Christian Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Siteman Cancer Center-South County
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Springfield
CoxHealth South Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
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
Washington
Mercy Hospital Washington
Status: ACTIVE
Contact: Site Public Contact
Phone: 636-390-1600

Montana

Anaconda
Community Hospital of Anaconda
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Billings
Billings Clinic Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-996-2663
Bozeman
Bozeman Deaconess Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Kalispell
Kalispell Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Missoula
Community Medical Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Saint Patrick Hospital - Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-327-3118

Nebraska

Grand Island
CHI Health Saint Francis
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Kearney
CHI Health Good Samaritan
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Lincoln
Saint Elizabeth Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Omaha
Alegent Health Bergan Mercy Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Alegent Health Immanuel Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Alegent Health Lakeside Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Creighton University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Papillion
Midlands Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Nevada

Carson City
Carson Tahoe Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Henderson
21st Century Oncology-Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Cancer and Blood Specialists-Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Cancer Center-Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Urology - Green Valley
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Pebble
Status: ACTIVE
Contact: Site Public Contact
OptumCare Cancer Care at Seven Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Urology Specialists of Nevada - Green Valley
Status: ACTIVE
Contact: Site Public Contact
Las Vegas
21st Century Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
21st Century Oncology-Fort Apache
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
21st Century Oncology-Vegas Tenaya
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Alliance for Childhood Diseases / Cure 4 the Kids Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Ann M Wierman MD LTD
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Cancer and Blood Specialists-Shadow
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Cancer and Blood Specialists-Tenaya
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Central Valley
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Northwest
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Town Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Summerlin
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Desert West Surgery
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
HealthCare Partners Medical Group Oncology / Hematology-Centennial Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
HealthCare Partners Medical Group Oncology / Hematology-Maryland Parkway
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
HealthCare Partners Medical Group Oncology / Hematology-San Martin
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
HealthCare Partners Medical Group Oncology / Hematology-Tenaya
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Hope Cancer Care of Nevada
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Cancer Center-Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Prostate Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Cathedral Rock
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Pecos
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Smoke Ranch
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Sunset
Status: ACTIVE
Contact: Site Public Contact
OptumCare Cancer Care at Fort Apache
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at MountainView
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at Oakey
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Radiation Oncology Centers of Nevada Central
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Radiation Oncology Centers of Nevada Southeast
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Summerlin Hospital Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Sunrise Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
University Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
University Medical Center of Southern Nevada
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Urology Specialists of Nevada - Central
Status: ACTIVE
Contact: Site Public Contact
Urology Specialists of Nevada - Northwest
Status: ACTIVE
Contact: Site Public Contact
Urology Specialists of Nevada - Southwest
Status: ACTIVE
Contact: Site Public Contact
Pahrump
Hope Cancer Care of Nevada-Pahrump
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Reno
Radiation Oncology Associates
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Renown Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Saint Mary's Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013

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
Manchester
Elliot Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 603-663-1800

New Jersey

Hamilton
The Cancer Institute of New Jersey Hamilton
Status: ACTIVE
Contact: Site Public Contact
Phone: 609-631-6946
Livingston
Saint Barnabas Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 973-322-2934
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE
Contact: Site Public Contact
Phone: 732-235-7356
Somerville
Robert Wood Johnson University Hospital Somerset
Status: ACTIVE
Contact: Site Public Contact
Phone: 908-685-2481

New Mexico

Albuquerque
Lovelace Medical Center-Saint Joseph Square
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-272-0530
Lovelace Women's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-272-0530
Presbyterian Kaseman Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 505-559-6113
University of New Mexico Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-925-0366
Las Cruces
Memorial Medical Center - Las Cruces
Status: ACTIVE
Contact: Site Public Contact
Phone: 575-556-6545
Rio Rancho
Presbyterian Rust Medical Center / Jorgensen Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 505-559-6113

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
Montefiore Medical Center-Einstein Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 718-379-6866
Montefiore Medical Center-Weiler Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 718-379-6866
Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-767-9355
East Syracuse
Hematology Oncology Associates of Central New York-East Syracuse
Status: ACTIVE
Contact: Site Public Contact
Phone: 315-472-7504
Glens Falls
Glens Falls Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 518-926-6700
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

North Carolina

Clinton
Southeastern Medical Oncology Center-Clinton
Status: ACTIVE
Contact: Site Public Contact
Phone: 919-587-9084
Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Status: ACTIVE
Contact: Site Public Contact
Phone: 919-587-9084
Hendersonville
Margaret R Pardee Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 828-696-4716
Jacksonville
Southeastern Medical Oncology Center-Jacksonville
Status: ACTIVE
Contact: Site Public Contact
Phone: 910-587-9084

Ohio

Beavercreek
Indu and Raj Soin Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Boardman
Saint Elizabeth Boardman Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Centerville
Dayton Physicians LLC-Miami Valley South
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Miami Valley Hospital South
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Cincinnati
Bethesda North Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Good Samaritan Hospital - Cincinnati
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Oncology Hematology Care Inc-Kenwood
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
TriHealth Cancer Institute-Anderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
TriHealth Cancer Institute-Westside
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Cleveland
MetroHealth Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 216-778-8526
Dayton
Dayton Physician LLC-Miami Valley Hospital North
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Miami Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Findlay
Armes Family Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Blanchard Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Orion Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Franklin
Atrium Medical Center-Middletown Regional Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Dayton Physicians LLC-Atrium
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Greenville
Dayton Physicians LLC-Wayne
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Wayne Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Kettering
First Dayton Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270
Greater Dayton Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Kettering Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Springfield
Springfield Regional Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-528-2900
Springfield Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-528-2900
Troy
Dayton Physicians LLC-Upper Valley
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Upper Valley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Warren
Saint Joseph Warren Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Youngstown
Saint Elizabeth Youngstown Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900

Oklahoma

Lawton
Cancer Centers of Southwest Oklahoma Research
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-231-4440
Oklahoma City
Mercy Hospital Oklahoma City
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-752-3402
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Baker City
Saint Alphonsus Medical Center-Baker City
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Bend
Saint Charles Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 541-706-2909
Clackamas
Clackamas Radiation Oncology Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Providence Cancer Institute Clackamas Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Coos Bay
Bay Area Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 541-269-8392
Newberg
Providence Newberg Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Ontario
Saint Alphonsus Medical Center-Ontario
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Portland
Providence Portland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Providence Saint Vincent Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Redmond
Saint Charles Health System-Redmond
Status: ACTIVE
Contact: Site Public Contact
Phone: 541-706-2909

Pennsylvania

Chadds Ford
Christiana Care Health System-Concord Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Danville
Geisinger Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
Hazleton
Geisinger Medical Center-Cancer Center Hazleton
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-459-2901
Lewisburg
Geisinger Medical Oncology-Lewisburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-374-8555
Lewistown
Lewistown Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-242-7703
Philadelphia
Fox Chase Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-728-4790
Pottsville
Geisinger Cancer Services-Pottsville
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-275-6401
Scranton
Community Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-703-4768
Selinsgrove
Geisinger Medical Oncology-Selinsgrove
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-374-8555
State College
Geisinger Medical Group
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
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

Puerto Rico

Bayamon
Cancer Center-Metro Medical Center Bayamon
Status: ACTIVE
Contact: Site Public Contact
Phone: 787-395-7085
Caguas
HIMA San Pablo Oncologic Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 787-653-3434
Manati
Doctors Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 787-621-4397
Ponce
Instituto Oncologia Moderna Ponce
Status: ACTIVE
Contact: Site Public Contact
Phone: 787-848-0606
San Juan
Centro Comprensivo de Cancer de UPR
Status: ACTIVE
Contact: Site Public Contact
San Juan City Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 787-763-1296
San Juan Community Oncology Group
Status: ACTIVE
Contact: Site Public Contact
Phone: 787-274-3387

Rhode Island

Providence
Women and Infants Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 401-274-1122

Tennessee

Bristol
Wellmont Bristol Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 423-578-8538
Kingsport
Regional Cancer Center at Indian Path Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 423-578-8538
Wellmont Holston Valley Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 423-578-8538

Texas

Bryan
Saint Joseph Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Dallas
Parkland Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 214-590-5582
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Site Public Contact
Phone: 214-648-7097
Fort Worth
UT Southwestern / Simmons Cancer Center-Fort Worth
Status: ACTIVE
Contact: Site Public Contact
Phone: 214-648-7097
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 713-798-1354
Ben Taub General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 713-873-2000
Laredo
Doctor's Hospital of Laredo
Status: ACTIVE
Contact: Site Public Contact
Phone: 956-523-2650
Richardson
UT Southwestern Clinical Center at Richardson / Plano
Status: ACTIVE
Contact: Site Public Contact
Phone: 972-669-7044

Virginia

Bristol
Wellmont Medical Associates-Bristol
Status: ACTIVE
Contact: Site Public Contact
Phone: 423-578-8538
Mechanicsville
Bon Secours Memorial Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 804-893-8611
Midlothian
Bon Secours Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 804-893-8611
Norfolk
Bon Secours DePaul Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 804-893-8611
Norton
Southwest VA Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 423-578-8538
Portsmouth
Bon Secours Maryview Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 804-893-8611
Richmond
Bon Secours Cancer Institute at Reynolds Crossing
Status: ACTIVE
Contact: Site Public Contact
Phone: 804-893-8611
Bon Secours Saint Mary's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 804-893-8611
VCU Massey Cancer Center at Stony Point
Status: ACTIVE
Contact: Site Public Contact
Phone: 804-628-1939
Virginia Commonwealth University / Massey Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 804-628-1914
South Hill
VCU Community Memorial Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 434-774-2442
Suffolk
Bon Secours Health Center at Harbour View
Status: ACTIVE
Contact: Site Public Contact
Phone: 757-398-4234

Washington

Aberdeen
Providence Regional Cancer System-Aberdeen
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Bellevue
Overlake Hospital Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 425-688-5407
Bellingham
PeaceHealth Saint Joseph Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-788-8238
Bremerton
Harrison HealthPartners Hematology and Oncology-Bremerton
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Harrison Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Burien
Highline Medical Center-Main Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Centralia
Providence Regional Cancer System-Centralia
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Edmonds
Swedish Cancer Institute-Edmonds
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Enumclaw
Saint Elizabeth Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Everett
Providence Regional Cancer Partnership
Status: ACTIVE
Contact: Site Public Contact
Phone: 425-261-3529
Federal Way
Saint Francis Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Issaquah
Swedish Cancer Institute-Issaquah
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Kennewick
Kadlec Clinic Hematology and Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 509-783-4637
Lacey
Providence Regional Cancer System-Lacey
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Lakewood
Saint Clare Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Longview
PeaceHealth Saint John Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-514-2016
Poulsbo
Harrison HealthPartners Hematology and Oncology-Poulsbo
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Renton
Valley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 425-228-3440
Seattle
Pacific Gynecology Specialists
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-Ballard Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-Cherry Hill
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-First Hill
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Sedro-Woolley
PeaceHealth United General Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-788-8238
Shelton
Providence Regional Cancer System-Shelton
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Tacoma
Franciscan Research Center-Northwest Medical Plaza
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Vancouver
PeaceHealth Southwest Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-514-3940
Walla Walla
Providence Saint Mary Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 509-897-5993
Yelm
Providence Regional Cancer System-Yelm
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958

Wisconsin

Appleton
ThedaCare Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-364-3605
Eau Claire
Mayo Clinic Health System Eau Claire Hospital-Luther Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Mayo Clinic Health System-Eau Claire Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
Saint Vincent Hospital Cancer Center at Saint Mary's
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
La Crosse
Gundersen Lutheran Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 608-775-2385
Mayo Clinic Health System-Franciscan Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Oconto Falls
Saint Vincent Hospital Cancer Center at Oconto Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
Sturgeon Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889

Wyoming

Cody
Billings Clinic-Cody
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-996-2663
Sheridan
Welch Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060

PRIMARY OBJECTIVES:

I. To determine if 3-year recurrence-free survival (RFS) is greater than 92% among clinical stages II or IIIa patients with HER2-positive breast cancer who achieve pathologic complete response (pCR) (ypT0/is ypN0) after preoperative therapy with 12 weeks of a taxane, trastuzumab (or Food and Drug Administration [FDA] approved biosimilar) and pertuzumab (THP x 12).

SECONDARY OBJECTIVES:

I. To determine 3-year IDFS (invasive disease-free survival), DDFS (distant disease-free survival), DRFS (distant relapse-free survival), RFI (recurrence-free interval), OS (overall survival) and breast cancer-specific survival in patients who achieve pCR (and by pretreatment clinical stage). (Secondary Clinical Objective)

II. To determine 3-year EFS (event-free survival) in all patients from time of study registration. (Secondary Clinical Objective)

III. To evaluate safety and tolerability for all patients during the pre-operative phase and for patients who attain pCR and de-escalate therapy (Arm A) until the completion of post-surgery protocol assigned therapy (i.e. until the end of trastuzumab and pertuzumab [HP] therapy). (Secondary Clinical Objective)

IV. To evaluate the association of estrogen receptor (ER) status in the untreated primary tumor with pathologic response and with long-term survival outcomes (including RFS, EFS, IDFS, DDFS, DRFS, RFI, OS, and breast cancer-specific survival). (Secondary Correlative Objective)

V. To evaluate the associations of detection of circulating tumor cells (CTCs) in the blood at baseline with pCR. (Secondary Correlative Objective)

VI. To evaluate the association of detection of CTCs in the blood at baseline, after 3 weeks of THP, after 12 weeks of THP (before surgery), after surgery before any additional therapy, and after completion of HER2-targeted therapy with RFS in patients who achieve pCR or not. (Secondary Correlative Objective)

EXPLORATORY OBJECTIVES:

I. To determine 3-year RFS, IDFS (invasive disease-free survival), DDFS (distant disease-free survival), DRFS (distant relapse-free survival), RFI (recurrence-free interval), OS (overall survival) and breast cancer-specific survival in patients who do not achieve pCR (and by pretreatment clinical stage). (Exploratory Clinical Objective)

II. To determine the pathologic response to THP neoadjuvant therapy, as assessed by residual cancer burden (RCB). (Exploratory Clinical Objective)

III. To determine the association between residual cancer burden (RCB) and all described standardized definitions for efficacy end points (STEEP) criteria outcomes. (Exploratory Clinical Objective)

IV. To determine the false negative rate (FNR) of limited staging procedures (defined as sentinel lymph node biopsy [SLNB] plus removal of clipped node) in patients who undergo such procedures with a planned axillary lymph node dissection (ALND). (Exploratory Clinical Objective)

V. To determine axillary pCR rates as a function of the burden of disease at presentation as determined on pre-treatment ultrasound (US) and the axillary staging technique (SLNB plus ensuring removal of clipped node versus ALND). (Exploratory Clinical Objective)

VI. To evaluate the associations between plasma tumor cell-free deoxyribonucleic acid (DNA) (cfDNA) tumor-specific mutations (baseline and after therapy) with pathologic response and long-term outcomes (including RFS, EFS, IDFS, DDFS, DRFS, RFI, OS, and breast cancer-specific survival). (Exploratory Correlative Objective)

VII. To evaluate the associations between tumor infiltrating lymphocytes (TILs) and immune activation gene signatures in the baseline tumor with pathologic response and long-term outcomes (including RFS, EFS, IDFS, DDFS, DRFS, RFI, OS and breast cancer-specific survival). (Exploratory Correlative Objective)

VIII. To determine the frequency of change in intrinsic subtype between pretreatment tumor specimen and residual disease at the time of surgery. (Exploratory Correlative Objective)

IX. To evaluate the associations between DNA copy number, DNA mutations, ribonucleic acid (RNA) expression and protein expression in the baseline tumor and changes from baseline to post-THP therapy with pathologic response and long-term outcomes (including RFS, EFS, IDFS, DDFS, DRFS, RFI, OS, and breast cancer-specific survival). (Exploratory Correlative Objective)

OUTLINE:

PRE-OPERATIVE/NEOADJUVANT THERAPY: Patients receive either paclitaxel or nab-paclitaxel intravenously (IV) on days 1, 8 and 15, or docetaxel IV on day 1 at the discretion of the treating oncologist. Patients also receive trastuzumab IV on day 1 or days 1, 8, and 15, and pertuzumab IV on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

SURGERY: Within 42 days after last dose of neoadjuvant therapy, patients undergo standard of care lumpectomy and/or mastectomy.

POST-OPERATIVE/ADJUVANT THERAPY: Patients are assigned to 1 of 2 arms.

ARM A: Patients with pCR after surgery receive trastuzumab and pertuzumab IV on day 1. Treatment repeats every 21 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo standard of care radiation therapy and receive hormone therapy if appropriate.

ARM B: Patients with remaining tumor after surgery receive standard of care trastuzumab emtansine for 14 doses in the absence of disease progression or unacceptable toxicity. Patients may also receive additional standard of care chemotherapy, as well as hormone therapy if appropriate.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2-5 years, then annually for 5-15 years from date of surgery.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
ECOG-ACRIN Cancer Research Group

Principal Investigator
Nadine Muskatel Tung

  • Primary ID EA1181
  • Secondary IDs NCI-2019-07439
  • Clinicaltrials.gov ID NCT04266249