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Satraplatin for Patients With Metastatic Breast Cancer (MBC)

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ClinicalTrials.gov Identifier: NCT00265655
Recruitment Status : Completed
First Posted : December 15, 2005
Last Update Posted : March 28, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Satraplatin Phase 2

Detailed Description:

This is a Phase II open label, nonrandomized study for patients with metastatic breast cancer.


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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II of Oral Satraplatin in Patients With Metastatic Breast Cancer (MBC)
Study Start Date : November 2005
Primary Completion Date : January 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Intervention Details:
    Drug: Satraplatin
    Patients will receive 80mg/m2 Satraplatin on Days 1-5 of Cycles 1 and 2. A cycle consists of 21 days.

Primary Outcome Measures :
  1. To determine the objective response rate (ORR) of oral satraplatin in patients with metastatic breast cancer [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To determine duration of response [ Time Frame: 6 weeks ]
  2. To determine progression-free survival (PFS) [ Time Frame: 1 year ]
  3. To determine 1-year survival [ Time Frame: 1 year ]
  4. To evaluate the toxicities of satraplatin in MBC patients [ Time Frame: 6 weeks ]
  5. 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 [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00265655

United States, Texas
US Oncology
Dallas, Texas, United States, 75204
Sponsors and Collaborators
Principal Investigator: Joyce O'Shaughnessy, MD US Oncology

Responsible Party: Agennix
ClinicalTrials.gov Identifier: NCT00265655     History of Changes
Other Study ID Numbers: Protocol 05-021
First Posted: December 15, 2005    Key Record Dates
Last Update Posted: March 28, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents