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ACTIVE NOT RECRUITING

NCT00433511

PHASE3

Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and 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. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery and help prevent the tumor from returning. It is not yet known whether doxorubicin hydrochloride, cyclophosphamide, and paclitaxel are more effective with or without bevacizumab.

Official title: A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Bevacizumab or Placebo in Patients With Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4994

Start Date

2007-11-02

Completion Date

2027-02-20

Last Updated

2026-05-29

Healthy Volunteers

Conditions

Breast Adenocarcinoma

Interventions

BIOLOGICAL

Bevacizumab

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Paclitaxel

Given IV

OTHER

Placebo Administration

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies (closed as of 5/28/10)

Inclusion Criteria: * Patients must have histologically confirmed adenocarcinoma of the breast at significant risk of distant recurrence based on at least one of the following criteria: * For axillary lymph node positive disease: * Involvement of at least one sentinel or axillary lymph node on routine histologic examination; patients with negative sentinel nodes and negative axillary nodes or involvement only demonstrated by immunohistochemistry are not eligible unless they meet one of the other eligibility criteria below * NOTE: consider intramammary nodes as equivalent to axillary nodes for the purposes of eligibility and stratification * For axillary lymph node negative disease: * Estrogen receptor (ER) negative tumor \>= 1 cm * ER+ tumor \>= 5 cm regardless of recurrence score * ER+ tumor \>= 1 cm but \< 5 cm with a recurrence score \>= 11 (patients enrolled in the TAILORx trial are eligible) * NOTE: axillary dissection is strongly encouraged in patients with lymph node involvement identified on sentinel node biopsy * Patients must have completed definitive breast surgery including total mastectomy and axillary dissection (modified radical mastectomy), total mastectomy and sentinel node biopsy, breast conservation surgery and axillary dissection or breast conservation surgery and sentinel node biopsy * NOTE: breast conservation surgery includes lumpectomy, partial mastectomy, and excisional biopsy * Margins of breast conservation surgery or mastectomy must be histologically free of invasive breast cancer and ductal carcinoma in situ (DCIS); patients with resection margins positive for lobular carcinoma in situ (LCIS) are eligible * Time from last surgery for breast cancer (breast conservation surgery, mastectomy, sentinel node biopsy, axillary dissection or re-excision of breast conservation surgery margins) to planned treatment start date must be \> 28 days and =\< 84 days * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Within =\< 8 weeks prior to randomization: Absolute neutrophil count \>= 1,000/mm\^3 * Within =\< 8 weeks prior to randomization: Platelet count \>= 100,000/mm\^3 * Within =\< 8 weeks prior to randomization: Total bilirubin =\< 1.5 mg/dL * Within =\< 8 weeks prior to randomization: Aspartate aminotransferase (AST) =\< 2 times upper limit of normal(ULN) * Within =\< 8 weeks prior to randomization: Serum creatinine =\< 1.5 mg/dL * Within =\< 8 weeks prior to randomization: Urine protein:creatinine ratio \< 1.0 or 24-hour protein * Within =\< 8 weeks prior to randomization: Partial thromboplastin time (PTT) =\< 1.5 times ULN * Within =\< 8 weeks prior to randomization: Left ventricle ejection fraction (LVEF) \>= institutional limits of normal by multigated acquisition scan (MUGA) or echocardiogram (ECHO) * Patients who have undergone breast conservation surgery must receive radiation; prior to randomization, the investigator must specify the planned radiation technique: * Whole breast radiation (WBRT) after chemotherapy * Accelerated partial breast radiation (APBI) after chemotherapy * Accelerated partial breast radiation (APBI) prior to chemotherapy * NOTE: if APBI was completed prior to study entry, day 1 of protocol therapy must be at least 4 weeks after the completion of APBI * Post-mastectomy radiation therapy (RT) is required for all patients with a primary tumor of \>= 5 cm or involvement of 4 or more lymph nodes; post-mastectomy RT may be administered at the investigator's discretion for all other mastectomy patients * Patients with human epidermal growth factor receptor (HER)2 + (3+ by immunohistochemistry \[IHC\] or fluorescent in situ hybridization \[FISH\] ratio \>= 2) breast cancer are not eligible * Patients with synchronous bilateral breast cancer (diagnosed within one month) are eligible if the higher tumor, node, metastasis (TNM) stage tumor meets the eligibility criteria for this trial * Patients must not have clinical evidence of inflammatory disease or fixed axillary nodes at diagnosis * Patients must not have received prior cytotoxic chemotherapy or hormonal therapy for this breast cancer; prior treatment with an anthracycline, anthracenedione or taxane for any condition is not allowed * NOTE: prior use of tamoxifen for chemoprevention is allowed but must be discontinued at study entry; similarly, prior raloxifene use is allowed but must be discontinued at study entry * Patients must not have had any major surgical procedure within 28 days of planned treatment start date * NOTE: non-operative biopsy or placement of a vascular access device is not considered a major surgery * Patients may not have had placement of a vascular access device within 24 hours of planned day 1 of treatment * Patients must not have clinically significant cardiovascular or cerebrovascular disease, including: * Any history of * Cerebrovascular disease including transient ischemic attack (TIA), stroke or subarachnoid hemorrhage * Ischemic bowel * Within the last 12 months * Myocardial infarction * Unstable angina * New York Heart Association (NYHA) class II or greater congestive heart failure * Grade II or greater peripheral vascular disease * Uncontrolled hypertension defined as systolic blood pressure (SBP) \> 160 or diastolic blood pressure (DBP) \> 90 * Uncontrolled or clinically significant arrhythmia * NOTE: blood pressure must be obtained within =\< 8 weeks prior to randomization * NOTE: patients with controlled atrial fibrillation are eligible * Patients who require full-dose anticoagulation may enroll provided they meet the following criteria: * The patient must have an in-range international normalized ratio (INR) (usually between 2 and 3) on a stable dose of warfarin or be on stable dose of low molecular weight (LMW) heparin * The patient must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. varices) * NOTE: prophylactic use of anticoagulants to maintain patency of a vascular access device is permitted * Patients must not have a bleeding diathesis, hereditary or acquired bleeding disorder or coagulopathy * Patients must not have a non-healing wound or fracture; patients with an abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to randomization are not eligible * Patients must not have hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, Chinese hamster ovary cell products or other recombinant human antibodies * Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood or urine test within 7 days prior to randomization to rule out pregnancy * Women of childbearing potential and sexually active males must use an accepted and effective method of contraception

Locations (843)

Northeast Alabama Regional Medical Center

Anniston, Alabama, United States

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Providence Hospital

Mobile, Alabama, United States

Alaska Regional Hospital

Anchorage, Alaska, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

Virginia G Piper Cancer Care-Del Camino

Scottsdale, Arizona, United States

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

PCR Oncology

Arroyo Grande, California, United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Mills-Peninsula Medical Center

Burlingame, California, United States

East Bay Radiation Oncology Center

Castro Valley, California, United States

Eden Hospital Medical Center

Castro Valley, California, United States

Valley Medical Oncology Consultants-Castro Valley

Castro Valley, California, United States

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Kaiser Permanente-Fremont

Fremont, California, United States

Valley Medical Oncology Consultants-Fremont

Fremont, California, United States

Washington Hospital

Fremont, California, United States

California Cancer Associates for Research and Excellence (cCare)

Fresno, California, United States

Glendale Memorial Hospital and Health Center

Glendale, California, United States

Marin Cancer Care Inc

Greenbrae, California, United States

Marin General Hospital

Greenbrae, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Fremont - Rideout Cancer Center

Marysville, California, United States

Community Hospital of Monterey Peninsula

Monterey, California, United States

El Camino Hospital

Mountain View, California, United States

Palo Alto Medical Foundation-Camino Division

Mountain View, California, United States

Sutter Cancer Research Consortium

Novato, California, United States

Wilma Chan Highland Hospital

Oakland, California, United States

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Bay Area Tumor Institute

Oakland, California, United States

Hematology and Oncology Associates-Oakland

Oakland, California, United States

Tom K Lee Inc

Oakland, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Desert Regional Medical Center

Palm Springs, California, United States

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Valley Care Health System - Pleasanton

Pleasanton, California, United States

Valley Medical Oncology Consultants

Pleasanton, California, United States

Pomona Valley Hospital Medical Center

Pomona, California, United States

Eisenhower Medical Center

Rancho Mirage, California, United States

Kaiser Permanente-Redwood City

Redwood City, California, United States

Kaiser Permanente-Richmond

Richmond, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Kaiser Permanente-South Sacramento

Sacramento, California, United States

Kaiser Permanente Sacramento Medical Center

Sacramento, California, United States

Salinas Valley Memorial

Salinas, California, United States

UC San Diego Medical Center - Hillcrest

San Diego, California, United States

Kaiser Permanente-San Diego Mission

San Diego, California, United States

Sharp Memorial Hospital

San Diego, California, United States

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

UCSF Medical Center-Mount Zion

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Kaiser Permanente San Leandro

San Leandro, California, United States

Doctors Medical Center- JC Robinson Regional Cancer Center

San Pablo, California, United States

Kaiser Permanente-San Rafael

San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Saint Helena Hospital

St. Helena, California, United States

Kaiser Permanente-Stockton

Stockton, California, United States

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Boulder Community Foothills Hospital

Boulder, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Kaiser Permanente-Franklin

Denver, Colorado, United States

AdventHealth Porter

Denver, Colorado, United States

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Saint Joseph Hospital - Cancer Centers of Colorado

Denver, Colorado, United States

Rose Medical Center

Denver, Colorado, United States

Western States Cancer Research NCORP

Denver, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

Banner North Colorado Medical Center

Greeley, Colorado, United States

Kaiser Permanente-Rock Creek

Lafayette, Colorado, United States

CommonSpirit Saint Anthony Hospital Cancer Center

Lakewood, Colorado, United States

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

Banner North Colorado Medical Center - Loveland Campus

Loveland, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

North Suburban Medical Center

Thornton, Colorado, United States

Intermountain Health Lutheran Hospital

Wheat Ridge, Colorado, United States

Danbury Hospital

Danbury, Connecticut, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

Middlesex Hospital

Middletown, Connecticut, United States

The Hospital of Central Connecticut

New Britain, Connecticut, United States

Norwalk Hospital

Norwalk, Connecticut, United States

Stamford Hospital/Bennett Cancer Center

Stamford, Connecticut, United States

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, United States

Bayhealth Hospital Kent Campus

Dover, Delaware, United States

Beebe Medical Center

Lewes, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 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

George Washington University Medical Center

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

Howard University Hospital

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

Lynn Regional Cancer Center - West

Boca Raton, Florida, United States

Boca Raton Comprehensive Cancer Center

Boca Raton, Florida, United States

Boca Raton Regional Hospital

Boca Raton, Florida, United States

Halifax Health Cancer Center for Hope - Daytona Beach

Daytona Beach, Florida, United States

Broward Health North

Deerfield Beach, Florida, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Florida Cancer Specialists-Gainesville Cancer Center

Gainesville, Florida, United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Jupiter Medical Center

Jupiter, Florida, United States

Lakeland Regional Health Hollis Cancer Center

Lakeland, Florida, United States

The Watson Clinic

Lakeland, Florida, United States

Cancer Centers of Central Florida PA

Leesburg, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Cleveland Clinic-Weston

Weston, Florida, United States

University Cancer and Blood Center LLC

Athens, Georgia, United States

Grady Health System