- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00028977
Herbal Therapy in Treating Women With Metastatic Breast Cancer
A Pilot Safety, Feasibility, Efficacy And Correlative (Phase I/II) Study Assessing Herba Scutellaria Barbatae (HSB) For Metastatic Breast Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94115
- UCSF Comprehensive Cancer Center
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Florida
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Plantation, Florida, United States, 33324
- Cancer Research Network, Incorporated
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Hope S. Rugo, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000069155
- UCSF-CRO-00758
- UCSF-IND-59521
- NCI-G01-2043
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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