Satraplatin for Patients With Metastatic Breast Cancer (MBC)

Agennix

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: Satraplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00265655

Protocol 05-021

Details and patient eligibility

About

To determine the objective response rate (ORR) of oral satraplatin in patients with Metastatic Breast Cancer.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)