Breast Cancer
Conditions
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
Interventions
DRUGCapecitabine
Capecitabine
DRUGThalidomide
Thalidomide
Sponsors
Celgene Corporation
SCRI Development Innovations, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | 18 Months |
Outcome results
None listed