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

Launched by UNICANCER · Feb 5, 2003

Keywords

ClinConnect Summary

OBJECTIVES:

* Compare the efficacy of adjuvant cyclophosphamide, epirubicin, and fluorouracil vs adjuvant docetaxel and epirubicin, in terms of 5-year survival without relapse, in women with nonmetastatic adenocarcinoma of the breast with lymph node invasion.
* Determine survival of patients treated with these regimens.
* Compare the tolerability of trastuzumab (Herceptin) in patients treated with these regimens.
* Determine the efficacy and tolerability of trastuzumab in patients with hormone receptor-positive tumors.
* Evaluate the quality of life of patients treated with these regimens....

Gender

FEMALE

Eligibility 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