Herbal Therapy in Treating Women With Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: The Chinese herb Scutellaria barbata contains ingredients that may slow the growth of cancer cells and may be an effective treatment for metastatic breast cancer.

PURPOSE: Phase I/II trial to study the effectiveness of Scutellaria barbata in treating women who have metastatic breast cancer.

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

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer (may include original primary cancer diagnosis)

• Measurable disease

• Metastatic involvement with minimal or no symptoms

• Solitary metastases require histological confirmation

• No extensive liver involvement (more than 50% of liver parenchyma)

• No lymphangitic pulmonary involvement

• CNS involvement or spinal cord compression allowed if stabilized by therapy for more than 3 months

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-1

Life expectancy:

• More than 6 months

Hematopoietic:

• WBC at least 2,500/mm^3

• Platelet count at least 75,000/mm^3

Hepatic:

• See Disease Characteristics

• Bilirubin no greater than 1.7 mg/dL

Renal:

• Creatinine no greater than 2.0 mg/dL

Other:

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

• No history of multiple or severe food or medicine allergies

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 1 week since prior biologic therapy

• No concurrent anticancer biologic therapy

Chemotherapy:

• At least 1 week since prior chemotherapy

• No concurrent anticancer chemotherapy

Endocrine therapy:

• At least 1 week since prior hormonal therapy

• No concurrent anticancer hormonal therapy

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• Recovered from prior anticancer therapy

• At least 1 week since prior investigational agents

• At least 1 week since prior herbal medications

• No other concurrent anticancer therapy

• No other concurrent investigational agents

• Concurrent pamidronate allowed

• Concurrent acupuncture or other nonherbal therapy allowed

• Concurrent nutritional vitamin supplementation (up to 5 times recommended daily allowance) allowed