Combination Chemotherapy After Surgery With or Without Chinese Herbal Therapy to Treat Symptoms in Women With Breast Cancer

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Herbs used in traditional Chinese medicine may decrease the side effects of chemotherapy.

PURPOSE: Randomized phase I/II trial to study the effectiveness of herbs used in traditional Chinese medicine in decreasing the side effects of chemotherapy after surgery in women who have stage I, stage II, or early stage III breast cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage I, II, or early stage III breast cancer for which adjuvant doxorubicin and cyclophosphamide is recommended

• No metastatic disease

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• Over 18

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Karnofsky 80-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Hemoglobin at least 9.0 g/dL

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• AST no greater than 2 times normal

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No evidence of acute ischemic cardiac disease on ECG

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No history of multiple severe food or medicine allergies or sensitivities

• No medical or psychological condition that would preclude study participation

• No severe concurrent illness

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent immunotherapy

Chemotherapy:

• See Disease Characteristics

• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent hormonal therapy

Radiotherapy:

• At least 3 weeks since prior radiotherapy

• No concurrent radiotherapy

Surgery:

• Not specified

Other:

• At least 3 weeks since prior investigational agents

• At least 3 weeks since prior herbal therapy

• No other concurrent investigational agents

• No other concurrent herbal therapy or alternative medicine

• Concurrent acupuncture allowed