RATIONALE: The Chinese herb scutellaria barbatae 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 barbatae in treating women who have metastatic breast cancer.

Condition	Treatment or Intervention	Phase
stage IV breast cancer recurrent breast cancer	Drug: herba scutellaria barbatae  Procedure: biologically based therapies  Procedure: cancer prevention intervention  Procedure: complementary and alternative therapy  Procedure: herbal medicine / botanical therapy	Phase I Phase II

Further Study Details: 

OBJECTIVES:

• Determine the efficacy of herba scutellaria barbatae (Chinese herbal extract) in terms of tumor response in women with metastatic breast cancer.
• Determine the safety and toxicity of this therapy in these patients.
• Determine the feasibility of this therapy in these patients.
• Determine the time to progression, overall survival, and resource utilization of patients treated with this therapy.
• Determine the quality of life of patients treated with this therapy.
• Determine the bioavailability and pharmacokinetics of this therapy in these patients.

OUTLINE: Patients receive oral herba scutellaria barbatae (Chinese herbal extract) twice daily for 12 months in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

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

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

California
      UCSF Comprehensive Cancer Center, San Francisco,  California,  94115-1710,  United States; Recruiting
Florida
      Cancer Research Network, Inc., Plantation,  Florida,  33324,  United States; Recruiting

Study chairs or principal investigators

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

Study ID Numbers:  CDR0000069155; UCSF-CRO-00758; UCSF-IND-59521; NCI-G01-2043; NCT00028977
Record last reviewed:  December 2003
Last Updated:  April 4, 2005
Record first received:  January 4, 2002
ClinicalTrials.gov Identifier:  NCT00028977
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08