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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

Tracking Information
First Submitted Date  ICMJE June 29, 2006
First Posted Date  ICMJE July 4, 2006
Results First Submitted Date  ICMJE October 5, 2015
Results First Posted Date  ICMJE December 14, 2015
Last Update Posted Date December 14, 2015
Study Start Date  ICMJE September 2006
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2015)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 29, 2006)
Determine the overall, partial, clinical complete and pathological complete response rate to capecitabine dose of 1,000 mg/m2 twice daily given for 24 weeks as neoadjuvant therapy for locally advanced, non-metastatic breast cancer.
Change History Complete list of historical versions of study NCT00347438 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2006)
  • Document toxicity associated with capecitabine dose of 1,000 mg/m2 twice daily.
  • Investigate the effects of capecitabine on gene and protein expression profiles of intracellular and extracellular mediators that regulate cell growth and survival.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: Capecitabine
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
Study Arms  ICMJE Experimental: Capecitabine
Capecitabine will be given at 1000mg/m2 twice daily for 2 weeks x 8 cycles, with a one-week pause in-between cycles.
Intervention: Drug: Capecitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 14, 2014)
18
Original Enrollment  ICMJE
 (submitted: June 29, 2006)
48
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with locally advanced, histologically confirmed adenocarcinoma of the female breast. Women with ulcerated breast lesions may be enrolled. Patients with asymptomatic metastases to the bone are eligible.
  • Ability to provide written informed consent prior to study-specific screening procedures
  • TNM Stage:T3-4, N0-3 M0; Patients with asymptomatic bone metastases may be enrolled. Patients with large T2 tumors whose surgeons believe their results with breast conserving surgery will be improved by neoadjuvant therapy may be enrolled.
  • Age 18 years or older
  • Negative serum or urine pregnancy test within 7 days prior to starting therapy (female patients of childbearing potential).
  • Performance status 0-1
  • Required Initial Laboratory Data:
  • Granulocytes >=1,200/µl
  • Platelet count >=100,000/µl
  • Calculated Creatinine Clearance > 30 mL/min
  • Total bilirubin <= Upper Limit Normal
  • Alkaline Phosphatase <=Upper Limit Normal
  • SGPT, SGOT <=Upper Limit Normal
  • Normal chest x-ray

Exclusion Criteria:

  • HER2 positive breast cancer
  • Pregnant or lactating woman
  • Life expectancy < 3 months
  • Serious, uncontrolled, concurrent infection(s)
  • Any prior fluoropyrimidine therapy or other chemotherapy
  • Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hyper-sensitivity to 5-fluorouracil or known DPD deficiency.
  • Patients who have received more than four weeks of tamoxifen therapy for this malignancy.
  • Treatment for other carcinomas within the last five years, except cured non- melanoma skin and treated in-situ cervical cancer.
  • Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
  • Evidence of metastatic disease to sites other than the bone or with symptomatic bone lesions.
  • Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
  • Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
  • Known, existing uncontrolled coagulopathy or concurrent treatment with Coumadin and Phenytoin
  • Any of the following laboratory values:
  • Abnormal hematologic values (neutrophils < 1.0 x 109/L, platelet count < 100 x 109/L)
  • Impaired renal function (estimated creatinine clearance <30ml/min as calculated with Cockcroft-Gault equation)
  • Serum bilirubin > upper normal limit.
  • SGOT, SGPT > upper normal limit
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Nigeria,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00347438
Other Study ID Numbers  ICMJE 14201B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE
  • Breast Cancer Research Foundation
  • Roche Pharma AG
Investigators  ICMJE
Principal Investigator: Olufunmilayo I Olopade, MD University of Chicago
PRS Account University of Chicago
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP