Herbal Therapy in Treating Women With Metastatic Breast Cancer
NCT ID: NCT00028977
Last Updated: 2012-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
21 participants
INTERVENTIONAL
2001-08-31
2006-04-30
Brief Summary
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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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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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herba scutellaria barbata
herba scutellaria Barbatae (HSB)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Hope S. Rugo, MD
Role: STUDY_CHAIR
University of California, San Francisco
Locations
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UCSF Comprehensive Cancer Center
San Francisco, California, United States
Cancer Research Network, Incorporated
Plantation, Florida, United States
Countries
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Other Identifiers
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UCSF-CRO-00758
Identifier Type: -
Identifier Source: secondary_id
UCSF-IND-59521
Identifier Type: -
Identifier Source: secondary_id
NCI-G01-2043
Identifier Type: -
Identifier Source: secondary_id
CDR0000069155
Identifier Type: -
Identifier Source: org_study_id