NCT00028977

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started Aug 2001

Typical duration for phase_1 breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

September 17, 2012

Status Verified

September 1, 2012

Enrollment Period

4.7 years

First QC Date

January 4, 2002

Last Update Submit

September 13, 2012

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Interventions

herba scutellaria barbataDRUG
herba scutellaria Barbatae (HSB)OTHER
Also known as: Traditional Chinese Medicine

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Cancer Research Network, Incorporated

Plantation, Florida, 33324, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ban-zhi-lianMedicine, Chinese Traditional

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Medicine, East Asian TraditionalMedicine, TraditionalComplementary TherapiesTherapeutics

Study Officials

  • Hope S. Rugo, MD

    University of California, San Francisco

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2002

First Posted

January 27, 2003

Study Start

August 1, 2001

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

September 17, 2012

Record last verified: 2012-09

Locations

US(2)