Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer

November 5, 2015 updated by: University of Chicago

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
      • Ibadan, Nigeria
        • University of Ibadan
      • Ile-Ife, Nigeria
        • Obafemi Awolowo University
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After the first three cycles of therapy, an average of 9 weeks
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.
After the first three cycles of therapy, an average of 9 weeks
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.
After the first three cycles of therapy, an average of 9 weeks
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.
After the first three cycles of therapy, an average of 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Roche Pharma AG
Breast Cancer Research Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

June 29, 2006

First Submitted That Met QC Criteria

June 29, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

December 14, 2015

Last Update Submitted That Met QC Criteria

November 5, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14201B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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