Epirubicin and Tamoxifen With or Without Docetaxel in Treating Postmenopausal Women With Breast Cancer

• 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. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. Combining chemotherapy with hormone therapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of epirubicin and tamoxifen with or without docetaxel in treating postmenopausal women who have breast cancer that has spread to the lymph nodes.

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

Details

• Lead Sponsor: International Collaborative Cancer Group
• Treatments: Docetaxel; Epirubicin; Tamoxifen

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven node-positive breast cancer

• Postmenopausal

• Last menstrual period more than 12 months before initial surgery OR

• Any age with prior bilateral oophorectomy OR

• Age 50 or over with prior hysterectomy without oophorectomy (unrelated to malignancy)

• No distant metastases

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• See Disease Characteristics

Sex:

• Female

Menopausal status:

• See Disease Characteristics

Performance status:

• WHO (ECOG) 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm3 OR

• Absolute neutrophil count at least 1,500/mm3

• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin normal

• SGOT and SGPT no greater than 1.5 times normal

• Alkaline phosphatase no greater than 1.5 times normal

Renal:

• Creatinine less than 1.5 times normal

Cardiovascular:

• No history of significant angina, congestive heart failure, or myocardial infarction within the past year

• No clinically significant arrhythmias or uncontrolled hypertension

• LVEF normal by MUGA, LV gated scan, or echocardiogram

Other:

• No other concurrent serious illness

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics