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Phase II of Oral Satraplatin in Patients With Metastatic Breast Cancer (MBC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Breast Cancer

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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 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

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 OncologyHouston, Texas  77060