Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

• Status: Completed
• Trial end date: 2009-12-01
• 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. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy with or without trastuzumab is more effective in treating breast cancer.

PURPOSE: Randomized phase III trial to compare two different chemotherapy regimens plus radiation therapy with or without trastuzumab in treating women who have breast cancer that has spread to lymph nodes in the axilla (under the arm).

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

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed nonmetastatic, unilateral adenocarcinoma of the breast

• Axillary lymph node invasion (N1, N2, or N3)

• No cutaneous invasion

• No T4a or greater disease

• No clinically or radiologically suspected metastases

• No clinically or radiologically suspected contralateral lesion

• No deeply adherent or inflammatory disease

• Complete surgical resection performed, including removal of at least 5 lymph nodes, and with no residual tumor, within the past 42 days

• No prior breast cancer

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 18 to 64

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

• ALT and AST no greater than 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase no greater than 2.5 times ULN

• Bilirubin no greater than ULN

• Hepatitis B and hepatitis C negative

• No hepatic dysfunction

Renal

• Creatinine less than 1.3 mg/dL OR

• Creatinine clearance greater than 60 mL/min

Cardiovascular

• ECHO normal

• LVEF at least 50%

Pulmonary

• FEV normal

• No dyspnea at rest

• No supplemental oxygen dependence

Other

• Not pregnant

• Fertile patients must use effective contraception

• HIV negative

• No active infection

• No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix

• No contraindication to anthracycline therapy

• No chronic medical or psychological condition

• No geographic or social reason that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• At least 4 weeks since prior chemotherapy

• No other concurrent chemotherapy

• No contraindication to anthracycline therapy

Endocrine therapy

• No prior hormonal therapy

Radiotherapy

• No prior radiotherapy

Surgery

• See Disease Characteristics

Other

• At least 4 weeks since prior experimental therapy