Status:

COMPLETED

Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer

Lead Sponsor:

Emory University

Collaborating Sponsors:

Georgia Center for Oncology Research & Education

Sanofi

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

The purpose of this study is to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

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 t...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

August 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2012

Estimated Enrollment :

51 Patients enrolled

Trial Details

Trial ID

NCT00209092

Start Date

August 1 2006

End Date

October 1 2012

Last Update

March 27 2015

Active Locations (19)

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Page 1 of 5 (19 locations)

1

Grady Memorial Hospital

Atlanta, Georgia, United States, 30303

2

Emory Crawford Long Hospital

Atlanta, Georgia, United States, 30308

3

Emory University Winship Cancer Institute

Atlanta, Georgia, United States, 30322

4

Augusta Oncology Associates, PC 1348 Walton Way, Ste. 4300

Augusta, Georgia, United States, 30901