NCT00265655

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 1, 2005

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 15, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

March 28, 2012

Status Verified

March 1, 2012

Enrollment Period

2.2 years

First QC Date

December 1, 2005

Last Update Submit

March 22, 2012

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (5)

  • 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

Interventions

SatraplatinDRUG

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

US Oncology

Dallas, Texas, 75204, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

satraplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Joyce O'Shaughnessy, MD

    US Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2005

First Posted

December 15, 2005

Study Start

November 1, 2005

Primary Completion

January 1, 2008

Study Completion

February 1, 2008

Last Updated

March 28, 2012

Record last verified: 2012-03

Locations

US(1)