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A Pilot Safety, Feasibility, Efficacy And Correlative (Phase I/II) Study Assessing Herba Scutellaria Barbatae (HSB) For Metastatic Breast Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Pilot Safety, Feasibility, Efficacy And Correlative (Phase I/II) Study Assessing Herba Scutellaria Barbatae (HSB) For Metastatic Breast Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Hope S. Rugo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000069155

NCT ID:

NCT00028977

Start Date:

August 2001

Completion Date:

April 2006

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Cancer Research Network, IncorporatedPlantation, Florida  33324