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Completed

NCT Number: NCT00265655

Satraplatin for Patients With Metastatic Breast Cancer (MBC)

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

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

US Oncology

Dallas, Texas, 75204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Has cytologically or pathologically confirmed breast cancer that is metastatic
  • 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)
  • Has had no more than 1 prior chemotherapy regimen for MBC
  • Has had no prior platinum-based therapy
  • Has an ECOG Performance Status (PS) 0-2

Treatment and study plan

Satraplatin

Drug

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

Primary outcomes

  1. To determine the objective response rate (ORR) of oral satraplatin in patients with metastatic breast cancer

    Time frame: 1 year

Secondary outcomes

  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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Agennix

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Dec 15, 2005
Registry last updated
Mar 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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