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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
Sponsor:
Collaborators:
Breast Cancer Research Foundation
Roche Pharma AG
Information provided by (Responsible Party):
University of Chicago

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Drug: Capecitabine
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Capecitabine
Hide Arm/Group Description Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
Period Title: Overall Study
Started 18
Completed 16
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Physician Decision             1
Arm/Group Title Capecitabine
Hide Arm/Group Description Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
50.1  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
18
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Overall Clinical Response Rate (OCR)
Hide Description 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.
Time Frame After the first three cycles of therapy, an average of 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.
Arm/Group Title Capecitabine
Hide Arm/Group Description:
Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: percentage of participants
31.3
2.Primary Outcome
Title Partial Clinical Response Rate (PR)
Hide Description 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.
Time Frame After the first three cycles of therapy, an average of 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.
Arm/Group Title Capecitabine
Hide Arm/Group Description:
Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: participants
5
3.Primary Outcome
Title Complete Clinical Response Rate (CCR)
Hide Description 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.
Time Frame After the first three cycles of therapy, an average of 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.
Arm/Group Title Capecitabine
Hide Arm/Group Description:
Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: percentage of participants
0
4.Primary Outcome
Title Complete Pathologic Response Rate (cPR)
Hide Description 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.
Time Frame After the first three cycles of therapy, an average of 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.
Arm/Group Title Capecitabine
Hide Arm/Group Description:
Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: percentage of participants
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Capecitabine
Hide Arm/Group Description Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
All-Cause Mortality
Capecitabine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Capecitabine
Affected / at Risk (%)
Total   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Capecitabine
Affected / at Risk (%)
Total   15/16 (93.75%) 
Gastrointestinal disorders   
Diarrhea  3/16 (18.75%) 
Nausea  1/16 (6.25%) 
General disorders   
Fatigue  1/16 (6.25%) 
Metabolism and nutrition disorders   
Anorexia  1/16 (6.25%) 
Nervous system disorders   
Dizziness  1/16 (6.25%) 
Respiratory, thoracic and mediastinal disorders   
Sore throat  1/16 (6.25%) 
Skin and subcutaneous tissue disorders   
Skin rash  1/16 (6.25%) 
Hand and foot syndrome  12/16 (75.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Funmi Olopade
Organization: University of Chicago Medical Center
Phone: 773-702-1632
EMail: folopade@medicine.bsd.uchicago.edu
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00347438     History of Changes
Other Study ID Numbers: 14201B
First Submitted: June 29, 2006
First Posted: July 4, 2006
Results First Submitted: October 5, 2015
Results First Posted: December 14, 2015
Last Update Posted: December 14, 2015