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A Prospective Randomized Comparison of CMF Versus Sequential Epirubicin Followed by SMF as Adjuvant Chemotherapy for Women With Early Breast Cancer


Phase 3
N/A
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

A Prospective Randomized Comparison of CMF Versus Sequential Epirubicin Followed by SMF as Adjuvant Chemotherapy for Women With Early Breast Cancer


OBJECTIVES: I. Compare the effects of 4 courses of epirubicin followed by 4 courses of
cyclophosphamide/methotrexate/fluorouracil (CMF) versus 8 courses of CMF as adjuvant
chemotherapy in women with node positive early breast cancer, as measured by overall and
event free survival from the date or randomization. II. Compare the effects of 4 courses of
epirubicin followed by 4 courses of CMF with 8 courses of CMF as adjuvant chemotherapy in
these patients, as measured by acute and chronic toxicities. III. Compare the effects of 4
courses of epirubicin followed by 4 courses of CMF versus 8 courses of CMF as adjuvant
chemotherapy in these patients, as measured by quality of life.

OUTLINE: This is a randomized, multicenter study. Patients are randomized into 2 treatment
arms within 4 weeks of surgery. Treatment begins within 6 weeks of surgery. One treatment
arm receives 8 courses of cyclophosphamide/methotrexate/fluorouracil (CMF) given
intravenously (IV) every 3 weeks. The other arm receives 4 courses of epirubicin followed by
4 courses of CMF given IV every 3 weeks. Patients are followed annually for 10 years.

PROJECTED ACCRUAL: A total of 1,000 patients will be accrued over 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed, early stage, unilateral invasive breast
cancer of TNM stages T0 - T3, N0-1, M0, i.e., Histologically proven axillary node
metastases OR Lymph node negative Not locally advanced If supraclavicular node is enlarged
or suspicious of metastasis, negative biopsy for supraclavicular node metastases required
No evidence of any other metastases clinically or on routine staging investigations No
past history of pure in situ carcinoma in either breast Primary tumor is completely
excised

PATIENT CHARACTERISTICS: Age: Not specified Sex: Female Performance status: Not specified
Hematopoietic: Neutrophil count greater than 2,000/mm3 Platelet count greater than
100,000/mm3 No evidence of sepsis Hepatic: Adequate hepatic function Bilirubin normal
AST/ALT normal Renal: Adequate renal function Creatinine less than 1.2 mg/dL
Cardiovascular: No clinically significant cardiovascular disease Other: No prior or
concurrent other malignancy except adequately treated basal or squamous cell carcinoma of
the skin or in situ carcinoma of the cervix Not pregnant or nursing Fertile patients must
use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Prior tamoxifen allowed Radiotherapy: No prior
radiotherapy Surgery: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Chris Twelves, MD, BMedSci, FRCP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Glasgow

Authority:

United States: Federal Government

Study ID:

CDR0000065590

NCT ID:

NCT00003012

Start Date:

October 1996

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms

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