Metastatic Breast Cancer Clinical Trial
Official title:
Phase II of Oral Satraplatin in Patients With Metastatic Breast Cancer (MBC)
Verified date | March 2012 |
Source | Agennix |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To determine the objective response rate (ORR) of oral satraplatin in patients with Metastatic Breast Cancer.
Status | Completed |
Enrollment | 40 |
Est. completion date | February 2008 |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
1. Has cytologically or pathologically confirmed breast cancer that is metastatic 2. Must have had prior HerceptinÃ’ 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | US Oncology | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Agennix |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the objective response rate (ORR) of oral satraplatin in patients with metastatic breast cancer | 1 year | Yes | |
Secondary | To determine duration of response | 6 weeks | Yes | |
Secondary | To determine progression-free survival (PFS) | 1 year | Yes | |
Secondary | To determine 1-year survival | 1 year | Yes | |
Secondary | To evaluate the toxicities of satraplatin in MBC patients | 6 weeks | Yes | |
Secondary | In patients with nonmeasurable MBC, to assess the clinical utility of serum CA27.29 (or CA15.3) and circulating tumor cells as predictors of time to disease progression | 6 weeks | Yes |
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