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Herbal Therapy in Treating Women With Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 4, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date September 17, 2012
Study Start Date  ICMJE August 2001
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Herbal Therapy in Treating Women With Metastatic Breast Cancer
Official Title  ICMJE A Pilot Safety, Feasibility, Efficacy And Correlative (Phase I/II) Study Assessing Herba Scutellaria Barbatae (HSB) For Metastatic Breast Cancer
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: herba scutellaria barbata
  • Other: herba scutellaria Barbatae (HSB)
    Other Name: Traditional Chinese Medicine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September¬†13,¬†2012)
21
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2006
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00028977
Other Study ID Numbers  ICMJE CDR0000069155
UCSF-CRO-00758
UCSF-IND-59521
NCI-G01-2043
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Hope S. Rugo, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP