Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00347438|
Recruitment Status : Terminated (a result of slow accrual)
First Posted : July 4, 2006
Results First Posted : December 14, 2015
Last Update Posted : December 14, 2015
The purpose of this study is to assess the safety and effectiveness of capecitabine before surgery.
The study will also help gain more information about the effects of the capecitabine on physical and emotional well-being and how well the participants on capecitabine follow the study drug plan.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Capecitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study to Evaluate the Efficacy, Safety, and Genomic Markers of Response of Capecitabine as NeoAdjuvant Therapy in Women With Newly Diagnosed Locally Advanced Breast Cancer|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
Capecitabine will be given at 1000mg/m2 twice daily for 2 weeks x 8 cycles, with a one-week pause in-between cycles.
Capecitabine twice daily for 14 days followed by 7 days without taking drug (1 cycle). This schedule is followed for 8 cycles (about 24 weeks).
Other Name: Xeloda
- Overall Clinical Response Rate (OCR) [ Time Frame: After the first three cycles of therapy, an average of 9 weeks ]Overall clinical response rate (OCR) was defined as a proportion of patients with a best response of Complete Clinical Response (CCR) or Partial Clinical Response (PCR). CCR was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease. PCR was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.
- Partial Clinical Response Rate (PR) [ Time Frame: After the first three cycles of therapy, an average of 9 weeks ]Partial Clinical Response (PR) was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.
- Complete Clinical Response Rate (CCR) [ Time Frame: After the first three cycles of therapy, an average of 9 weeks ]Complete Clinical Response (CCR) was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease.
- Complete Pathologic Response Rate (cPR) [ Time Frame: After the first three cycles of therapy, an average of 9 weeks ]Complete Pathologic Response rate (cPR) was defined as the absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery.
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): NCT00347438
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|University of Ibadan|
|Obafemi Awolowo University|
|Principal Investigator:||Olufunmilayo I Olopade, MD||University of Chicago|