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Trial record 10 of 46 for:    herbal medicine | United States

Herbal Therapy in Treating Women With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00028977
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 17, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: herba scutellaria barbata Other: herba scutellaria Barbatae (HSB) Phase 1 Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Safety, Feasibility, Efficacy And Correlative (Phase I/II) Study Assessing Herba Scutellaria Barbatae (HSB) For Metastatic Breast Cancer
Study Start Date : August 2001
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


Intervention Details:
  • Drug: herba scutellaria barbata
  • Other: herba scutellaria Barbatae (HSB)
    Other Name: Traditional Chinese Medicine



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00028977


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
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Investigators
Study Chair: Hope S. Rugo, MD University of California, San Francisco

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00028977     History of Changes
Other Study ID Numbers: CDR0000069155
UCSF-CRO-00758
UCSF-IND-59521
NCI-G01-2043
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 17, 2012
Last Verified: September 2012

Keywords provided by University of California, San Francisco:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases