Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer

Phase 2

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT00193102
• Lead Sponsor: SCRI Development Innovations, LLC

Brief Summary

The lack of non-overlapping toxicities between the two drugs, the ease of all oral drug administration, and the possibility for antitumor synergy make exploration of this combination regimen attractive in women with previously treated metastatic breast cancer. This phase II trial will be performed in collaboration with the Minnie Pearl Cancer Research Network, a multicenter, community-based clinical trials group.

Detailed Description

Upon determination of eligibility, patients will be receive:

Thalidomide + Capecitebine

Study Timeline

• Study Start: 2001-04
• Primary Completion: 2005-02
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2010-06
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-02
• Last Update Posted: 2011-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

To be included in this study, you must meet the following criteria:

• Metastatic breast cancer confirmed by biopsy
• Measurable or evaluable disease
• Females > 18 years
• Able to perform activities of daily living with minimal assistance
• Life expectancy > 3 months
• Adequate bone marrow, liver and kidney function
• All patients must give written informed consent in order to participate.

Exclusion Criteria

You cannot participate in this study if any of the following apply to you:

• Women who are pregnant or lactating.
• Received more than 3 prior chemotherapy regimens in the metastatic setting.
• Received continuous infusion 5-fluorouracil lasting > 120 hours.
• Received thalidomide or capecitabine as their last prior regimen.
• Preexisting moderate to severe neuropathy

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall response rate	18 Months