Combination Chemotherapy in Treating Women With Stage I Breast Cancer

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating early breast cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of different regimens of combination chemotherapy in treating women who have stage I breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Cyclophosphamide; Epirubicin; Fluorouracil

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed nonmetastatic, unilateral adenocarcinoma of the breast

• Stage I

• No clinically or radiologically suspicious metastases

• No positive sentinel lymph nodes by immunohistochemistry for tumors less than 2 cm

• No clinically proven positive axillary lymph nodes

• Tumor cells found on immunohistochemistry only allowed

• No clinically or radiologically contralateral suspicious lesions

• No deeply adherent disease

• No cutaneous invasion

• No inflammatory disease

• Complete surgical resection within the past 42 days

• At least 8 lymph nodes removed

• Tumor at least 1 cm with no residual disease

• Presenting with at least 1 of the following factors of a poor prognosis:

• Tumor greater than 2 cm

• Hormone receptor negative tumor

• Grade II or III

• 35 years old or under

• Hormone receptor status:

• Positive or negative

PATIENT CHARACTERISTICS:

Age

• 18 to 65

Sex

• Female

Menopausal status

• Not specified

Performance status

• WHO 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC at least 2,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than 1.25 times upper limit of normal (ULN)

• AST and ALT no greater than 1.25 times ULN

• Alkaline phosphatase no greater than 2.5 times ULN

• No chronic hepatitis B

• No active hepatitis C

Renal

• Creatinine no greater than 1.25 times ULN

Pulmonary

• FEV normal

Other

• Not pregnant or nursing

• HIV negative

• No prior breast cancer or other malignancy

• No familial, social, or geographical reason that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• No prior anticancer hormone therapy

Radiotherapy

• No prior radiotherapy

Surgery

• See Disease Characteristics