Combination Chemotherapy in Treating Patients With Early Stage Breast Cancer That Has Been Removed By Surgery

• Status: Active, not recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating early stage breast cancer that has been removed by surgery.

PURPOSE: This randomized phase III trial is studying four different combination chemotherapy regimens to compare how well they work in treating patients with early stage breast cancer that has been removed by surgery.

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

Details

• Lead Sponsor: Institute of Cancer Research, United Kingdom
• Treatments: Capecitabine; Cyclophosphamide; Epirubicin; Fluorouracil; Methotrexate

Criteria

DISEASE CHARACTERISTICS:

• Histological diagnosis of invasive breast carcinoma

• Cytological proof of malignancy alone is not sufficient

• Early stage disease (T0-3, N0-2, M0) without clinical suspicion or evidence of distant metastases on routine staging

• No locally advanced breast cancer (T4 and/or N3 disease)

• Completely resected disease by breast-conserving surgery with axillary node clearance or modified radical mastectomy within the past 4-8 weeks

• Negative surgical margins required, unless either of the following are true:

• Deep surgical margins after full thickness resection

• Noninvasive cancer at surgical margins for which a mastectomy is planned after completion of study chemotherapy

• No contraindication for or refusal of postoperative radiotherapy in patients who underwent prior breast-conserving surgery

• Definite indication for adjuvant chemotherapy

• No prior or current invasive breast cancer or bilateral breast cancer

• Prior surgically-treated ductal carcinoma in situ or lobular carcinoma in situ allowed

• Hormone receptor status:

• Estrogen receptor- and/or progesterone receptor-positive or -negative tumor

PATIENT CHARACTERISTICS:

• Sex: male or female

• Menopausal status: premenopausal or postmenopausal

• No previous malignancy except basal cell carcinoma, carcinoma in situ of the cervix, or any cancer from which the patient has been disease-free for 10 years and for which treatment consisted solely of resection

• ECOG status 0 or 1

• Hemoglobin > 9 g/dL

• WBC > 3,000/mm³

• Platelet count > 10,000/mm³

• Bilirubin normal (unless due to known Gilbert's disease)

• AST and ALT ≤ 1.5 times upper limit of normal (ULN)

• Albumin normal

• Creatinine ≤ 1.5 times ULN

• Creatinine clearance > 50 mL/min

• No active, uncontrolled infection

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No concurrent medical, psychiatric, or geographic problems that might prevent completion of treatment or follow-up

• Available for a minimum of 5 years' follow-up

• No known serious viral infection such as active hepatitis B, hepatitis C, or HIV

• No significant cardiac disease, such as impaired left ventricular function or active angina requiring regular anti-anginal medication and/or resulting in restricted physical activity

• No history of significant renal impairment or disease

PRIOR CONCURRENT THERAPY:

• No simultaneous participation in the active intervention phase of another treatment trial

• Not being approached or recruited for another trial within 2 months of study entry

• No previous chemotherapy, hormonal therapy or radiotherapy for the treatment of pre-invasive or invasive cancer except for either of the following:

• Previous radiotherapy for basal cell carcinoma

• Previous preoperative endocrine therapy, provided there was no evidence of progression during this therapy, it lasted for less than 6 weeks in duration, and it was stopped at least one month prior to trial entry

• Concurrent luteinizing hormone-releasing hormone analog therapy allowed for premenopausal patients

• More than 4 weeks since prior hormone replacement therapy (HRT) or pre-operative endocrine therapy

• No prior breast conserving surgery if there is a contradiction for or refusal of postoperative radiotherapy