Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine for Early Stage Breast Cancer

February 12, 2007 updated by: Georgia Center for Oncology Research & Education

Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine as in Induction Therapy for Early Stage Breast Cancer

The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

Induction chemotherapy offers the possibility of less surgery and determines tumor sensitivity in vivo. Previous trials have demonstrated that complete pathologic response in the breast at surgery corresponds with improved outcome. Additionally, we will correlate specific molecular markers in the breast tumors before and after chemotherapy, with response to treatment.

Expression of these molecular markets may be used in the future to predict the likelihood of response to chemotherapy given post-operatively.

Approximately 100 patients will participate at Emory Winship Cancer Institute and Emory Crawford W. Long Hospital and Grady Health System in Atlanta, Georgia.

Study Type

Interventional

Enrollment

100

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

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute of Emory University
        • Contact:
          • Rita Johnson
          • Phone Number: 404-778-7777
        • Principal Investigator:
          • Ruth O'Regan
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Grady Memorial Hospital
        • Contact:
          • Rita Johnson
          • Phone Number: 404-778-7777
        • Principal Investigator:
          • Ruth O'Regan
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory Crawford Long Hospital
        • Contact:
          • Rita Johnson
          • Phone Number: 404-778-7777
        • Principal Investigator:
          • Ruth O'Regan

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:

  • Histologically or cytologically confirmed breast carcinoma.
  • Early stage breast cancer (stage 1, 2, 3).
  • No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.
  • 18 years of age or older.
  • Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Exclusion Criteria:

  • Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.
  • Major surgery within 28 days of study entry.
  • Evidence of CNS metastases.
  • Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Georgia Center for Oncology Research & Education

Collaborators

Sanofi

Investigators

  • Principal Investigator: Ruth O'Regan, MD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

December 1, 2006

Study Registration Dates

First Submitted

December 20, 2006

First Submitted That Met QC Criteria

December 20, 2006

First Posted (Estimate)

December 22, 2006

Study Record Updates

Last Update Posted (Estimate)

February 13, 2007

Last Update Submitted That Met QC Criteria

February 12, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EU822-03

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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