Combination Chemotherapy Before Surgery in Treating Women With Breast Cancer

• Status: Completed
• Trial end date: 1969-12-31
• 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 and shrink tumors so they can be removed during surgery.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy before surgery in treating women who have locally advanced, inflammatory, or large surgically removable breast cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Capecitabine; Cyclophosphamide; Epirubicin

Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed carcinoma of the breast Locally advanced or inflammatory disease (T4, any N or any T, N2 or N3 or T4d) OR Large operable disease (large T2 or T3 for which tumor shrinkage is needed) No distant metastasis on chest x-ray, liver ultrasound, or bone scan except for ipsilateral supraclavicular nodes No abnormal bone scintigrams that cannot be confirmed as benign Hormone Receptor Status Not specified

PATIENT CHARACTERISTICS: Age: 18 to 70 Sex: Female Menopausal status: Not specified Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: LVEF normal by echocardiography or MUGA Other: Not pregnant or nursing Fertile patients must use effective contraception No other serious uncontrolled illnesses No uncontrolled psychiatric or addictive disorders No other concurrent or prior malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix

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