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.

Condition	Treatment or Intervention	Phase
stage I breast cancer stage II breast cancer stage IIIA breast cancer recurrent breast cancer Drug Toxicity	Drug: Chinese herbs  Drug: cyclophosphamide  Drug: doxorubicin  Procedure: chemoprotection  Procedure: chemotherapy  Procedure: supportive care/therapy	Phase I Phase II

Further Study Details: 

OBJECTIVES:

• Determine the toxic effects and safety of chinese herbal therapy (CHT) when administered for toxicity attenuation in combination with adjuvant doxorubicin and cyclophosphamide in women with stage I, II, or early stage III breast cancer.
• Determine patient compliance and the feasibility of using CHT by daily treatment calendars, weekly symptom inventories, and quality of life and mood state questionnaires completed by these patients.
• Determine patient preferences and concerns about CHT.
• Determine, preliminarily, the efficacy of CHT in ameliorating the toxic effects/side effects of adjuvant chemotherapy with doxorubicin and cyclophosphamide, in terms of the incidence and severity of adverse events, in these patients.

OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are randomized to one of two treatment arms.

• Arm I: Patients receive adjuvant doxorubicin IV and cyclophosphamide IV over 1 hour on days 0, 21, 42, and 63. Patients also receive oral chinese herbal therapy three times daily on days -10 to 105.
• Arm II: Patients receive adjuvant chemotherapy as in arm I and oral placebo three times daily on days -10 to 105. Quality of life is assessed at baseline and on days 3, 24, 45, 66, 84, and 105.

Patients are followed at day 105.

PROJECTED ACCRUAL: A total of 60 patients (30 per treatment arm) will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

California
      UCSF Comprehensive Cancer Center, San Francisco,  California,  94115-1710,  United States

Study chairs or principal investigators

Hope S. Rugo, MD,  Study Chair,  University of California, San Francisco   

Study ID Numbers:  CDR0000069154; UCSF-CRO-97755; UCSF-IND-54870; NCI-G01-2042
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  January 4, 2002
ClinicalTrials.gov Identifier:  NCT00028964
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08