Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028977
Status:
COMPLETED
Last Update Posted:
2012-09-17
First Post:
2002-01-04
Brief Title:
Herbal Therapy in Treating Women With Metastatic Breast Cancer
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Pilot Safety Feasibility Efficacy And Correlative Phase III Study Assessing Herba Scutellaria Barbatae HSB For Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 III trial to study the effectiveness of Scutellaria barbata in treating women who have metastatic breast cancer
PURPOSE Phase III 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G01-2043 | None | None | None |
| UCSF-CRO-00758 | None | None | None |
| UCSF-IND-59521 | None | None | None |