Metastatic Breast Cancer
Conditions
Brief summary
To determine the objective response rate (ORR) of oral satraplatin in patients with Metastatic Breast Cancer.
Detailed description
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.
Interventions
DRUGSatraplatin
Patients will receive 80mg/m2 Satraplatin on Days 1-5 of Cycles 1 and 2. A cycle consists of 21 days.
Sponsors
Agennix
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the objective response rate (ORR) of oral satraplatin in patients with metastatic breast cancer | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| To determine duration of response | 6 weeks |
| To determine progression-free survival (PFS) | 1 year |
| To determine 1-year survival | 1 year |
| To evaluate the toxicities of satraplatin in MBC patients | 6 weeks |
| 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 |
Countries
United States
Outcome results
None listed