Sequential Adjuvant Chemotherapy With Doxorubicin, Taxol, and Cyclophosphamide for Stage II or III Resectable Breast Cancer With Four or More Involved Axillary Lymph Nodes
18 Years
N/A
Both
Breast Cancer
Trial Information
Sequential Adjuvant Chemotherapy With Doxorubicin, Taxol, and Cyclophosphamide for Stage II or III Resectable Breast Cancer With Four or More Involved Axillary Lymph Nodes
OBJECTIVES: I. Evaluate the efficacy of dose intensive, sequential adjuvant chemotherapy
with doxorubicin, paclitaxel, and cyclophosphamide in patients with stage II/III resected
breast cancer. II. Evaluate the toxicity of this regimen in these patients.
OUTLINE: All patients receive sequential chemotherapy regimens consisting of 3 courses each
of doxorubicin, paclitaxel, and cyclophosphamide on a schedule of one course every 14 days.
Following completion of chemotherapy, patients who underwent breast conservation surgery
receive radiotherapy. Mastectomy patients with 10 or more positive nodes or with T3-4 tumors
are also eligible for delayed radiotherapy. Patients who are hormone receptor positive (or
whose receptor status is unknown) are treated with oral tamoxifen for 5 years, beginning
after completion of all other therapy. Patients are followed every 3 months for 2 years,
every 6 months for 3 years, then yearly.
PROJECTED ACCRUAL: At total of 90 patients will be entered.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the breast with
involvement of 4 or more axillary nodes, including any T N1 M0 Concurrent bilateral breast
cancer allowed Complete resection required Total mastectomy or breast conserving surgery
Adjuvant radiotherapy planned after protocol chemotherapy Clear surgical margins Axillary
dissection yielding at least 9 lymph nodes Entry required within 8 weeks of definitive
surgery Hormone receptor status: Any status
PATIENT CHARACTERISTICS: Age: Over 18 Sex: Not specified Menopausal status: Not specified
Performance status: Karnofsky 80%-100% ECOG 0 or 1 Hematopoietic: Absolute granulocyte
count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL
Hepatic: Bilirubin no greater than 1.5 times normal AST no greater than 2 times normal
Alkaline phosphatase no greater than 2 times normal Renal: Creatinine no greater than 1.8
mg/dL OR Creatinine clearance at least 60 mL/min Urinalysis normal Cardiovascular: Left
ventricular ejection fraction normal on MUGA or echocardiogram No congestive heart failure
requiring medical therapy No serious arrhythmia No first-, second-, or third-degree heart
block Other: No abnormal CT of chest or abdomen No uncontrolled infection No serious
medical condition that would prevent treatment No second malignancy except curatively
treated: Nonmelanomatous skin cancer Carcinoma in situ of the cervix Not pregnant Negative
pregnancy test Barrier contraception required of fertile patients before, during, and for
6 months after protocol therapy
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic
chemotherapy Endocrine Therapy: No concurrent hormonal therapy unless unrelated to cancer
Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: No
concurrent medication affecting conduction unless cleared by a cardiologist, e.g.: Beta
blockers Digoxin Antiarrhythmia agents Calcium channel blockers
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Maysa Abu-Khalaf, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Yale University
Authority:
United States: Federal Government
Study ID:
CDR0000064337
NCT ID:
NCT00002679
Start Date:
February 1994
Completion Date:
January 2002
Related Keywords:
- Breast Cancer
- stage II breast cancer
- stage IIIA breast cancer
- male breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
