Comparison of Three Combination Chemotherapy Regimens in Treating Women With Stage I or Stage II Breast Cancer

• Status: Completed
• Trial end date: 2005-09-01
• 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.

PURPOSE: This randomized phase II trial is studying three regimens of combination chemotherapy to compare how well they work in treating women with stage I or stage II breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Marsden NHS Foundation Trust
• Treatments: Cyclophosphamide; Doxorubicin; Epirubicin; Liposomal doxorubicin; Mitoxantrone; Vinorelbine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary breast cancer that is potentially operable

• Synchronous bilateral tumors eligible

• At least 3 cm in maximum diameter

• Tumors at least 2 cm eligible provided primary chemotherapy is deemed appropriate and radical surgery would otherwise be required

• No evidence of metastatic disease

• No prior breast cancer

• 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:

• WBC at least 3,000/mm^3

• Platelet count at least 150,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• Transaminases no greater than 1.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No uncontrolled angina pectoris

• No heart failure

• No clinically significant uncontrolled cardiac arrhythmias

• LVEF at least 50%

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No medical or psychiatric condition that impairs ability to cope physically or psychologically with the chemotherapy regimen

• No other serious uncontrolled medical condition

• No other prior malignancy except basal cell carcinoma of the skin or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics