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Sequential Adjuvant Chemotherapy With Doxorubicin, Taxol, and Cyclophosphamide for Stage II or III Resectable Breast Cancer With Four or More Involved Axillary Lymph Nodes


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

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