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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Georgia Center for Oncology Research & Education.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sanofi
Information provided by:
Georgia Center for Oncology Research & Education
ClinicalTrials.gov Identifier:
NCT00415285
First received: December 20, 2006
Last updated: February 12, 2007
Last verified: February 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
 Drug: Docetaxel
Drug: Capecitabine
Drug: Docetaxel/Capecitabine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine as in Induction Therapy for Early Stage Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Georgia Center for Oncology Research & Education:

Estimated Enrollment: 100
Study Start Date: December 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415285

Contacts
Contact: Rita Johnson 404-778-7777

Locations
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Rita Johnson     404-778-7777        
Principal Investigator: Ruth O'Regan            
Emory Crawford Long Hospital Recruiting
Atlanta, Georgia, United States, 30308
Contact: Rita Johnson     404-778-7777        
Principal Investigator: Ruth O'Regan            
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Contact: Rita Johnson     404-778-7777        
Principal Investigator: Ruth O'Regan            
Sponsors and Collaborators
Georgia Center for Oncology Research & Education
Sanofi
Investigators
Principal Investigator: Ruth O'Regan, MD Winship Cancer Institute of Emory University
  More Information

Additional Information:
Georgia Center for Oncology Research and Education  This link exits the ClinicalTrials.gov site
Winship Cancer Institute  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00415285     History of Changes
Other Study ID Numbers: EU822-03
Study First Received: December 20, 2006
Last Updated: February 12, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Georgia Center for Oncology Research & Education:
Breast
Cancer
Early-Stage
Chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Docetaxel
Capecitabine
Fluorouracil
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013