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Herbal Therapy in Treating Women With Metastatic Breast Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Herbal Therapy in Treating Women With Metastatic Breast Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Herbal Therapy in Treating Women With Metastatic Breast Cancer Clinical research trials and Herbal Therapy in Treating Women With Metastatic Breast Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Herbal Therapy in Treating Women With Metastatic Breast Cancer. Herbal Therapy in Treating Women With Metastatic Breast Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Herbal Therapy in Treating Women With Metastatic Breast Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Herbal Therapy in Treating Women With Metastatic Breast Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "H" Clinical Trials Conditions > Herbal Therapy in Treating Women With Metastatic Breast Cancer  Herbal Therapy in Treating Women With Metastatic Breast Cancer
Herbal Therapy in Treating Women With Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: Recruiting
Sponsor(s): University of California, San Francisco , National Cancer Institute (NCI)
Synopsis: RATIONALE: The Chinese herb scutellaria barbatae 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 barbatae in treating women who have metastatic breast cancer.
Details: OBJECTIVES: - Determine the efficacy of herba scutellaria barbatae (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 herba scutellaria barbatae (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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HopeRugo, Study Chair, University of California, San Francisco
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115-1710
United States
Recruiting Hope Rugo 415-353-7428
Cancer Research Network Inc. *Recruiting*
Plantation, Florida, 33324
United States
Recruiting Charles Vogel 954-473-6776
Additional Information:
Study ID Numbers: CDR0000069155; NCI-G01-2043,UCSF-IND-59521,UCSF-CRO-00758
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028977
Other Recurrent Breast Cancer Studies:
1. Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer
2. Trastuzumab and Radiation Therapy in Treating Women With Stage III or Stage IV Invasive Primary Cancer of the Breast
3. Vinorelbine and Docetaxel in Treating Women With Metastatic Breast Cancer
4. Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer
5. Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer
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Herbal Therapy in Treating Women With Metastatic Breast Cancer
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