Combination Chemotherapy in Treating Women With Breast Cancer Who Have Undergone Surgery

• Status: Unknown status
• 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. It is not yet known which chemotherapy regimen is more effective in treating women after surgery for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel, epirubicin, and cyclophosphamide with or without gemcitabine in treating women who have undergone surgery for breast cancer.

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

Details

• Lead Sponsor: Cancer Research Campaign Clinical Trials Centre
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Epirubicin; Gemcitabine; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed newly diagnosed invasive breast cancer

• Early stage disease

• Completely resected disease

• No more than 8 weeks since prior resection

• Any nodal status

• Indication for adjuvant chemotherapy

• No metastatic disease

• Hormone receptor status:

• Estrogen receptor negative or weakly positive OR

• Estrogen receptor positive AND progesterone receptor negative or weakly positive

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 3,000/mm3

• Platelet count greater than 100,000/mm3

• Hemoglobin greater than 9 g/dL

Hepatic:

• Bilirubin normal

• AST and ALT no greater than 1.5 times normal

Renal:

• Creatinine no greater than 1.5 times normal

Other:

• Fit to receive study chemotherapy

• No active uncontrolled infection

• No other malignancy within the past 10 years except basal cell carcinoma or carcinoma in situ of the cervix

• No other concurrent medical or psychiatric problems that would preclude study

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• See Disease Characteristics