Combination Chemotherapy Before Surgery in Treating Women With Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00008034|
Recruitment Status : Completed
First Posted : February 3, 2004
Last Update Posted : July 18, 2012
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells and shrink tumors so they can be removed during surgery.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy before surgery in treating women who have locally advanced, inflammatory, or large surgically removable breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: capecitabine Drug: cyclophosphamide Drug: epirubicin hydrochloride||Phase 1|
OBJECTIVES: I. Determine the toxicity of neoadjuvant capecitabine, cyclophosphamide, and epirubicin in women with locally advanced or inflammatory or large operable breast cancer. II. Determine the maximum tolerated dose of this regimen in this patient population.
OUTLINE: This is a multicenter dose escalation study of capecitabine. Patients receive neoadjuvant cyclophosphamide IV and epirubicin IV on day 1 and oral capecitabine twice daily on days 1-14. Treatment continues every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: A total of 3-33 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Official Title:||A Phase I Study Of Cyclophoshamide And Epirubicin In Combination With Capecitabine (XELODA) (CEX) As Primary Treatment Of Locally Advanced/Inflammatory Or Large Operable Breast Cancer|
|Study Start Date :||February 2000|
|Actual Primary Completion Date :||December 2000|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00008034
|Hopital Cantonal Universitaire de Geneva|
|Geneva, Switzerland, CH-1211|
|Study Chair:||Herve Bonnefoi, MD||Hopital Cantonal Universitaire de Geneve|