Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Herbal Therapy in Treating Women With Metastatic Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 18 and over NCI UCSF-CRO-00758 UCSF-IND-59521, NCI-G01-2043, NCT00028977

Objectives

1. Determine the efficacy of Scutellaria barbata (Chinese herbal extract) in terms of tumor response in women with metastatic breast cancer.
2. Determine the safety and toxicity of this therapy in these patients.
3. Determine the feasibility of this therapy in these patients.
4. Determine the time to progression, overall survival, and resource utilization of patients treated with this therapy.
5. Determine the quality of life of patients treated with this therapy.
6. Determine the bioavailability and pharmacokinetics of this therapy in these patients.

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

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

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/mm³
• Platelet count at least 75,000/mm³

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

Expected Enrollment

A total of 25 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

UCSF Helen Diller Family Comprehensive Cancer Center

Hope Rugo, MD, Protocol chair		Ph: 415-353-7428; 800-888-8664 Email: hrugo@medicine.ucsf.edu

Registry Information
Official Title		A Pilot Safety, Feasibility, Efficacy And Correlative (Phase I/II) Study Assessing Herba Scutellaria Barbatae (HSB) For Metastatic Breast Cancer
Trial Start Date		2001-08-10
Registered in ClinicalTrials.gov		NCT00028977
Date Submitted to PDQ		2001-11-15
Information Last Verified		2008-12-29
NCI Grant/Contract Number		CA82103

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