Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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Upon determination of eligibility, patients will be receive:

Thalidomide + Capecitebine

Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Thalidomide

Intervention Type DRUG

Capecitabine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No