Phase II of Oral Satraplatin in Patients With Metastatic Breast Cancer (MBC)
18 Years
N/A
Both
Metastatic Breast Cancer
Trial Information
Phase II of Oral Satraplatin in Patients With Metastatic Breast Cancer (MBC)
This is a Phase II open label, nonrandomized study for patients with metastatic breast
cancer.
WHAT IS SATRAPLATIN:
Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based
drugs have been clinically proven to be one of the most effective classes of anticancer
therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given
orally.
Inclusion Criteria
1. Has cytologically or pathologically confirmed breast cancer that is metastatic
2. Must have had prior HerceptinÒ therapy if patient has HER2+ (overexpressing) breast
cancer. HER2 is considered overexpressed if it is 3+ by IHC or if the gene is
amplified by Flourescence in situ hybridization (FISH)
3. Has had no more than 1 prior chemotherapy regimen for MBC
4. Has had no prior platinum-based therapy
5. Has an ECOG Performance Status (PS) 0-2
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the objective response rate (ORR) of oral satraplatin in patients with metastatic breast cancer
Outcome Time Frame:
1 year
Safety Issue:
Yes
Principal Investigator
Joyce O'Shaughnessy, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
US Oncology
Authority:
United States: Food and Drug Administration
Study ID:
Protocol 05-021
NCT ID:
NCT00265655
Start Date:
November 2005
Completion Date:
February 2008
Related Keywords:
- Metastatic Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| US Oncology | Houston, Texas 77060 |
