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ACTIVE NOT RECRUITING

NCT00070564

PHASE3

S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer

Sponsor: SWOG Cancer Research Network

View on ClinicalTrials.gov

Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating resected breast cancer. PURPOSE: This randomized phase III trial is comparing 2 different regimens of combination chemotherapy to see how well they work in treating patients who have undergone surgery for stage I, stage II, or stage III breast cancer.

Official title: Phase III Trial of Continuous Schedule AC + G vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3294

Start Date

2003-11

Completion Date

2027-01

Last Updated

2025-07-31

Healthy Volunteers

Conditions

Breast Cancer

Interventions

BIOLOGICAL

pegfilgrastim

Given IV

DRUG

AC regimen

Given IV

DRUG

cyclophosphamide

Given IV

DRUG

doxorubicin hydrochloride

Given IV

DRUG

paclitaxel

Given IV

DISEASE CHARACTERISTICS: * Histologically confirmed stage I-III invasive breast cancer * Operable disease * Stage I, II, IIIA, and IIIC (T1-3, N3a only) * No T4 tumors * High-risk disease, defined by 1 of the following: * Tumor ≥ 2 cm in greatest diameter (includes both invasive and intraductal component) * Patients with nodal status of N0+ (i.e., no cluster of tumor cells in any node greater than 0.2 mm) are considered to be node negative and must have a primary tumor ≥ 2 cm in size or have a tumor ≥ 1 cm with high risk features * Patients who are node negative on the basis of a sentinel node procedure and fewer than 6 axillary nodes are removed are eligible OR at least 6 axillary or intramammary nodes must be negative * Tumor ≥ 1 cm in diameter and meeting 1 of the following criteria: * ER-negative and PgR-negative * ER-positive or PgR-positive with a Genomic Health Recurrence Score of ≥ 26 * One or more axillary or intramammary nodes are involved by metastatic breast cancer * If one or more nodes is involved, a minimum of 6 axillary or intramammary nodes must have been examined histologically * Patients with N0(I+) disease will be considered node negative * HER2/neu-positive tumors (3+ by immunohistochemical staining or amplified by fluorescence in-situ hybridization) allowed * Bilateral synchronous breast cancer diagnosed within 1 month of each other allowed provided the higher TNM stage primary tumor meets the eligibility criteria * Prior modified radical mastectomy OR local excision of all tumors with axillary lymph node dissection or sentinel node resection required * No more than 84 days since prior surgery for the primary tumor and/or axilla * Final resection margins for the primary tumor must be histologically negative for invasive cancer and ductal carcinoma in situ * Resection margins positive for lobular carcinoma in situ are allowed * Hormone receptor status: * Estrogen receptor status known * Progesterone receptor status known PATIENT CHARACTERISTICS: Age * 18 and over Sex * Male or female Menopausal status * Not specified Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,200/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than upper limit of normal (ULN) * Alkaline phosphatase no greater than 2 times ULN * SGOT or SGPT no greater than 2 times ULN Renal * Creatinine no greater than ULN Cardiovascular * No congestive heart failure * No active angina pectoris * LVEF greater than or equal to the lower limit of normal\* by MUGA or echocardiogram NOTE: Patients age 60 and over OR with a history of hypertension Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, in situ cervical carcinoma, or lobular carcinoma in situ of the breast * Prior invasive breast cancer or ductal carcinoma in situ allowed if disease-free for 5 years * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior cytotoxic chemotherapy for this breast cancer * No prior chemotherapy with an anthracycline, anthracenedione, or taxane Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy for this malignancy * At least 2 weeks since prior radiotherapy for ductal carcinoma in situ Surgery * See Disease Characteristics

Locations (542)

Regional Medical Center

Anniston, Alabama, United States

UAB Comprehensive Cancer Center

Birmingham, Alabama, United States

Providence Cancer Center at Providence Hospital

Mobile, Alabama, United States

Providence Cancer Center

Anchorage, Alaska, United States

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, United States

Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

Fort Smith, Arkansas, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Alta Bates Summit Comprehensive Cancer Center

Berkeley, California, United States

Peninsula Medical Center

Burlingame, California, United States

East Bay Radiation Oncology Center

Castro Valley, California, United States

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, United States

Valley Medical Oncology

Fremont, California, United States

California Cancer Center - Woodward Park Office

Fresno, California, United States

Todd Cancer Institute at Long Beach Memorial Medical Center

Long Beach, California, United States

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Tibotec Therapeutics - Division of Ortho Biotech Products, LP

Marysville, California, United States

Memorial Medical Center

Modesto, California, United States

El Camino Hospital Cancer Center

Mountain View, California, United States

Sutter Health - Western Division Cancer Research Group

Novato, California, United States

Highland General Hospital

Oakland, California, United States

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Bay Area Breast Surgeons, Incorporated

Oakland, California, United States

CCOP - Bay Area Tumor Institute

Oakland, California, United States

Larry G Strieff MD Medical Corporation

Oakland, California, United States

Tom K Lee, Incorporated

Oakland, California, United States

St. Joseph Hospital Regional Cancer Center - Orange

Orange, California, United States

Desert Regional Medical Center Comprehensive Cancer Center

Palm Springs, California, United States

Valley Medical Oncology Consultants - Pleasanton

Pleasanton, California, United States

Sutter Cancer Center at Roseville Medical Center

Roseville, California, United States

Sutter Cancer Center

Sacramento, California, United States

University of California Davis Cancer Center

Sacramento, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

California Pacific Medical Center - California Campus

San Francisco, California, United States

Doctors Medical Center - San Pablo Campus

San Pablo, California, United States

Sutter Solano Medical Center

Vallejo, California, United States

San Luis Valley Regional Medical Center

Alamosa, Colorado, United States

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, United States

Memorial Hospital Cancer Center - Colorado Springs

Colorado Springs, Colorado, United States

Denver Health Medical Center

Denver, Colorado, United States

Veterans Affairs Medical Center - Denver

Denver, Colorado, United States

Shaw Regional Cancer Center

Edwards, Colorado, United States

Valley View Hospital Cancer Center

Glenwood Springs, Colorado, United States

Montrose Memorial Hospital Cancer Center

Montrose, Colorado, United States

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Yale Cancer Center

New Haven, Connecticut, United States

Washington Cancer Institute at Washington Hospital Center

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

Herbert D. Kerman Regional Oncology Center - Daytona Beach

Daytona Beach, Florida, United States

Florida Hospital Memorial Medical Center

Daytona Beach, Florida, United States

Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

Fort Lauderdale, Florida, United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Ella Milbank Foshay Cancer Center at Jupiter Medical Center

Jupiter, Florida, United States

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, United States

Piedmont Hospital

Atlanta, Georgia, United States

Northside Hospital Cancer Center

Atlanta, Georgia, United States

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, United States

CCOP - Atlanta Regional

Atlanta, Georgia, United States

WellStar Cobb Hospital

Austell, Georgia, United States

John B. Amos Cancer Center

Columbus, Georgia, United States

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Decatur, Georgia, United States

Piedmont Fayette Hospital

Fayetteville, Georgia, United States

Dwight David Eisenhower Army Medical Center

Fort Gordon, Georgia, United States

Gwinnett Medical Center

Lawrenceville, Georgia, United States

Kennestone Cancer Center at Wellstar Kennestone Hospital

Marietta, Georgia, United States

Southern Regional Medical Center

Riverdale, Georgia, United States

Harbin Clinic Cancer Center - Medical Oncology

Rome, Georgia, United States

Pearlman Comprehensive Cancer Center at South Georgia Medical Center

Valdosta, Georgia, United States

Cancer Research Center of Hawaii