Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer

This study has been terminated.
(a result of slow accrual)
Sponsor:
Collaborators:
Breast Cancer Research Foundation
Roche Pharma AG
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00347438
First received: June 29, 2006
Last updated: November 5, 2015
Last verified: November 2015
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Capecitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Overall Clinical Response Rate (OCR) [ Time Frame: After the first three cycles of therapy, an average of 9 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 18
Study Start Date: September 2006
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347438

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Nigeria
University of Ibadan
Ibadan, Nigeria
Obafemi Awolowo University
Ile-Ife, Nigeria
Sponsors and Collaborators
University of Chicago
Breast Cancer Research Foundation
Roche Pharma AG
Investigators
Principal Investigator: Olufunmilayo I Olopade, MD University of Chicago
  More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00347438     History of Changes
Other Study ID Numbers: 14201B 
Study First Received: June 29, 2006
Results First Received: October 5, 2015
Last Updated: November 5, 2015
Health Authority: United States: Institutional Review Board
Nigeria: Institutional Review Board

Keywords provided by University of Chicago:
breast cancer
neoadjuvant
locally advanced

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 30, 2016