Herbal Therapy in Treating Women With Metastatic Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Determine the efficacy of Scutellaria barbata (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 Scutellaria barbata (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.

Official Title
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A Pilot Safety, Feasibility, Efficacy And Correlative (Phase I/II) Study Assessing Herba Scutellaria Barbatae (HSB) For Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: herba scutellaria barbata
* Other: herba scutellaria Barbatae (HSB)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: herba scutellaria barbata|nan|
|Other: herba scutellaria Barbatae (HSB)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer