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| Sponsor: | UCSF Helen Diller Family Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00028977 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Dietary Supplement: herba scutellaria barbata |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Pilot Safety, Feasibility, Efficacy And Correlative (Phase I/II) Study Assessing Herba Scutellaria Barbatae (HSB) For Metastatic Breast Cancer |
| Estimated Enrollment: | 25 |
| Study Start Date: | August 2001 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Metastatic involvement with minimal or no symptoms
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, California | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| United States, Florida | |
| Cancer Research Network, Incorporated | |
| Plantation, Florida, United States, 33324 | |
| Study Chair: | Hope S. Rugo, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000069155, UCSF-CRO-00758, UCSF-IND-59521, NCI-G01-2043 |
| Study First Received: | January 4, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00028977 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer |
|
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |