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Herbal Therapy in Treating Women With Metastatic Breast Cancer

Phase 1
Completed
Conditions
Breast Cancer
Registration Number
NCT00028977
Lead Sponsor
University of California, San Francisco
Brief 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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
21
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

UCSF Comprehensive Cancer Center

🇺🇸

San Francisco, California, United States

Cancer Research Network, Incorporated

🇺🇸

Plantation, Florida, United States

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