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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Neoplasms

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Trial Information

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.

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Ruth O'Regan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Winship Cancer Institute of Emory University

Authority:

United States: Institutional Review Board

Study ID:

EU822-03

NCT ID:

NCT00415285

Start Date:

December 2006

Completion Date:

Related Keywords:

  • Breast Neoplasms
  • Breast
  • Cancer
  • Early-Stage
  • Chemotherapy
  • Breast Neoplasms
  • Neoplasms

Name

Location

Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Grady Memorial HospitalAtlanta, Georgia  30335
Emory Crawford Long HospitalAtlanta, Georgia  30308