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ACTIVE NOT RECRUITING

NCT01872975

Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery

Sponsor: NSABP Foundation Inc

View on ClinicalTrials.gov

Summary

This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer

Official title: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1636

Start Date

2013-08

Completion Date

2028-08

Last Updated

2023-12-27

Healthy Volunteers

Conditions

Stage IB Breast Cancer Stage II Breast Cancer

Interventions

RADIATION

regional nodal XRT

RADIATION

chestwall XRT

RADIATION

WBI

Inclusion Criteria: * The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines * The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant therapy); clinical axillary nodal involvement can be assessed by palpation, ultrasound, CT scan, magnetic resonance imaging (MRI), positron emission tomography (PET) scan, or PET/CT scan * Patient must have had pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on either a positive fine needle aspirate (FNA) (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma); the FNA or core needle biopsy can be performed either by palpation or by image guidance; documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy) is not permitted * Patients must have had estrogen receptor (ER) analysis performed on the primary breast tumor before neoadjuvant therapy according to current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for hormone receptor testing; if negative for ER, assessment of progesterone receptor (PgR) must also be performed according to current ASCO/CAP guideline recommendations for hormone receptor testing (http://www.asco.org) * Patients must have had HER2 testing performed on the primary breast tumor before neoadjuvant chemotherapy according to the current ASCO/CAP guideline recommendations for human epidermal growth factor receptor 2 testing in Breast Cancer (http://www.asco.org); patients who have a primary tumor that is either HER2-positive or HER2-negative are eligible * Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen * For patients who receive adjuvant chemotherapy after surgery, a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization; (if treatment delays occur, chemotherapy must be completed within 14 weeks); the dose and schedule of the adjuvant chemotherapy are at the investigator's discretion; Note: It is preferred that all intended chemotherapy be administered in the neoadjuvant setting * Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated * At the time of definitive surgery, all removed axillary nodes must be histologically free from cancer; acceptable procedures for assessment of axillary nodal status at the time of surgery include: * Axillary node dissection * Sentinel node biopsy alone or * Sentinel node biopsy followed by axillary node dissection * Note: Patients are eligible whether there is residual invasive carcinoma in the surgical breast specimen or whether there is evidence of pathologic complete response; patients who are found to be pathologically node-positive at the time of surgery, based on sentinel node biopsy alone, are candidates for A011202, a study developed by the Alliance in Oncology, an NCI Cooperative Group; if A011202 is open at the investigator's institution, patients should be approached about participating in the A011202 study * Patients with pathologic staging of ypN0(i+) or ypN0(mol+) are eligible (Note: Postneoadjuvant therapy is designated with a "yp" prefix.) * Patient who have undergone either a total mastectomy or a lumpectomy are eligible * For patients who undergo lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS as determined by the local pathologist; additional operative procedures may be performed to obtain clear margins; if tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible; (patients with margins positive for lobular carcinoma in situ \[LCIS\] are eligible without additional resection) * For patients who undergo mastectomy, the margins must be histologically free of residual (microscopic or gross) tumor * The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 70 days; also, if adjuvant chemotherapy was administered, the interval between the last chemotherapy treatment and randomization must be no more than 70 days * The patient must have recovered from surgery with the incision completely healed and no signs of infection * If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved Exclusion Criteria: * Definitive clinical or radiologic evidence of metastatic disease * T4 tumors including inflammatory breast cancer * Documentation of axillary nodal positivity before neoadjuvant therapy by sentinel node biopsy alone * N2 or N3 disease detected clinically or by imaging * Patients with histologically positive axillary nodes post neoadjuvant therapy * Patients with microscopic positive margins after definitive surgery * Synchronous or previous contralateral invasive breast cancer or DCIS; (patients with synchronous and/or previous contralateral LCIS are eligible) * Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy; (patients with synchronous or previous ipsilateral LCIS are eligible) * 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 * Any radiation therapy for the currently diagnosed breast cancer prior to randomization * Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy; patients are eligible if these medications are discontinued prior to randomization * Prior breast or thoracic radiation therapy (RT) for any condition * Active collagen vascular disease, specifically dermatomyositis with a creatinine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma * Pregnancy or lactation at the time of study entry; (Note: Pregnancy testing must be performed within 2 weeks prior to randomization according to institutional standards for women of childbearing potential) * Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up * Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements

Locations (514)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

Arizona Breast Cancer Specialists-Gilbert

Gilbert, Arizona, United States

Arizona Center for Cancer Care-Peoria

Peoria, Arizona, United States

Arizona Breast Cancer Specialists-Phoenix

Phoenix, Arizona, United States

Arizona Breast Cancer Specialists-Scottsdale

Scottsdale, Arizona, United States

Arizona Center for Cancer Care-Surprise

Surprise, Arizona, United States

Arizona Oncology Associates-West Orange Grove

Tucson, Arizona, United States

The University of Arizona Medical Center-University Campus

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, United States

Mills - Peninsula Hospitals

Burlingame, California, United States

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, United States

Eden Hospital Medical Center

Castro Valley, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Epic Care-Dublin

Dublin, California, United States

Epic Care Partners in Cancer Care

Emeryville, California, United States

California Cancer Center - North Fresno

Fresno, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

City of Hope Antelope Valley

Lancaster, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

Los Angeles County-USC Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Hoag Memorial Hospital

Newport Beach, California, United States

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Kaiser Permanente Oakland-Broadway

Oakland, California, United States

Saint Joseph Hospital - Orange

Orange, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Desert Regional Medical Center

Palm Springs, California, United States

Huntington Memorial Hospital

Pasadena, California, United States

Pomona Valley Hospital Medical Center

Pomona, California, United States

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, United States

Rohnert Park Cancer Center

Rohnert Park, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

Sutter Roseville Medical Center

Roseville, California, United States

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, United States

Sutter General Hospital

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Naval Medical Center -San Diego

San Diego, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, United States

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Saint Helena Hospital

St. Helena, California, United States

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, United States

Sutter Cancer Centers Radiation Oncology Services-Vacaville

Vacaville, California, United States

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora, Colorado, United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Memorial Hospital Colorado Springs

Colorado Springs, Colorado, United States

Porter Adventist Hospital

Denver, Colorado, United States

The Shaw Regional Cancer Center

Edwards, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Rocky Mountain Cancer Centers-Thornton

Thornton, Colorado, United States

SCL Health Lutheran Medical Center

Wheat Ridge, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Middlesex Hospital

Middletown, Connecticut, United States

The Hospital of Central Connecticut

New Britain, Connecticut, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Florida Hospital Cancer Institute Altamonte

Altamonte Springs, Florida, United States

John Fitzgerald Kennedy Medical Center

Atlantis, Florida, United States

Morton Plant Hospital

Clearwater, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

University of Florida

Gainesville, Florida, United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Jackson Memorial Hospital-Holtz Children's Hospital

Miami, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

South Miami Hospital

Miami, Florida, United States

Baptist Hospital of Miami

Miami, Florida, United States

Florida Hospital Orlando

Orlando, Florida, United States

UF Cancer Center at Orlando Health

Orlando, Florida, United States

21st Century Oncology-Palatka

Palatka, Florida, United States

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Grady Health System