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Clinical Trials in Israel / NCT00070564
Active, not recruiting Phase 3

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

NCT00070564 · tracked via the Priya Life Science Israel tracker
Phase
Phase 3
Started
2003-11
Last updated
2026-08-28

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

pegfilgrastim →AC regimencyclophosphamide →doxorubicin hydrochloride →paclitaxel →

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (542)

FacilityCityRegionStatus
Regional Medical Center Anniston Alabama
UAB Comprehensive Cancer Center Birmingham Alabama
Providence Cancer Center at Providence Hospital Mobile Alabama
Providence Cancer Center Anchorage Alaska
Mayo Clinic Scottsdale Scottsdale Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center Tucson Arizona
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center Fort Smith Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas
Alta Bates Summit Comprehensive Cancer Center Berkeley California
Peninsula Medical Center Burlingame California
East Bay Radiation Oncology Center Castro Valley California
Valley Medical Oncology Consultants - Castro Valley Castro Valley California
Valley Medical Oncology Fremont California
California Cancer Center - Woodward Park Office Fresno California
Todd Cancer Institute at Long Beach Memorial Medical Center Long Beach California
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California
Contra Costa Regional Medical Center Martinez California
Tibotec Therapeutics - Division of Ortho Biotech Products, LP Marysville California
Memorial Medical Center Modesto California
El Camino Hospital Cancer Center Mountain View California
Sutter Health - Western Division Cancer Research Group Novato California
Highland General Hospital Oakland California
Alta Bates Summit Medical Center - Summit Campus Oakland California
Bay Area Breast Surgeons, Incorporated Oakland California
CCOP - Bay Area Tumor Institute Oakland California
Larry G Strieff MD Medical Corporation Oakland California
Tom K Lee, Incorporated Oakland California
St. Joseph Hospital Regional Cancer Center - Orange Orange California
Desert Regional Medical Center Comprehensive Cancer Center Palm Springs California
Valley Medical Oncology Consultants - Pleasanton Pleasanton California
Sutter Cancer Center at Roseville Medical Center Roseville California
Sutter Cancer Center Sacramento California
University of California Davis Cancer Center Sacramento California
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California
California Pacific Medical Center - California Campus San Francisco California
Doctors Medical Center - San Pablo Campus San Pablo California
Sutter Solano Medical Center Vallejo California
San Luis Valley Regional Medical Center Alamosa Colorado
University of Colorado Cancer Center at UC Health Sciences Center Aurora Colorado
Memorial Hospital Cancer Center - Colorado Springs Colorado Springs Colorado

+ 502 more sites — see the full list on the official registry below.

More SWOG Cancer Research Network trials in Israel

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00070564 on ClinicalTrials.gov ↗ ← All trials in Israel