Know Cancer

forgot password

Phase II Study of Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Phase II Study of Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer

Upon determination of eligibility, patients will be receive:

Thalidomide + Capecitebine

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Time Frame:

18 Months

Safety Issue:


Principal Investigator

Howard Burris, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

April 2001

Completion Date:

June 2010

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms