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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 and pertuzumab are both a form of “targeted therapy” because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach 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. 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 (estrogen 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 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)

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

California

Arroyo Grande
PCR Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013

Connecticut

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

Delaware

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

Illinois

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
Swedish Covenant Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-878-8200
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
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
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
Mount Vernon
Good Samaritan Regional Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-242-4600
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
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
Cancer Care Specialists of Illinois-Swansea
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Southwest Illinois Health Services LLP
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-236-1000

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
Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
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

Maine

Brewer
Lafayette Family Cancer Center-EMMC
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-987-3005

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
Winchester
Winchester Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-823-5923

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

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
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
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

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: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Cancer and Blood Specialists-Tenaya
Status: ACTIVE
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

New Jersey

Hamilton
The Cancer Institute of New Jersey Hamilton
Status: ACTIVE
Contact: Site Public Contact
Phone: 609-631-6946
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE
Contact: Site Public Contact
Phone: 732-235-8675

New York

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
Rochester
University of Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-275-5830

Oklahoma

Oklahoma City
Mercy Hospital Oklahoma City
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-752-3402

Pennsylvania

Chadds Ford
Christiana Care Health System-Concord Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
West Reading
Reading Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 610-988-9323

Washington

Bellevue
Overlake Hospital Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 425-688-5407
Renton
Valley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 425-228-3440

Wisconsin

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
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

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