Recruiting

Phase 2

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

Sponsor:

Georgia Center for Oncology Research & Education

Code:

NCT00415285

Conditions

Breast Neoplasms

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Docetaxel

Capecitabine

Docetaxel/Capecitabine

Study Details

Brief summary:

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.

Conditions

Breast Neoplasms

Study ID

NCT00415285

Start date

Dec, 2006

Status verified date

Feb, 2007

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Docetaxel

Capecitabine

Docetaxel/Capecitabine

Central Contacts and Locations

Central contacts

Rita Johnson

404-778-7777

Locations

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Rita Johnson

404-778-7777

Principal Investigator:

Ruth O'Regan

Emory Crawford Long Hospital

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Rita Johnson

404-778-7777

Principal Investigator:

Ruth O'Regan

Winship Cancer Institute of Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Rita Johnson

404-778-7777

Principal Investigator:

Ruth O'Regan

More Information

Sponsor

Georgia Center for Oncology Research & Education

Last update posted

Feb 13, 2007

Last verified

Feb, 2007

Keywords

Breast
Cancer
Early-Stage
Chemotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgia Center for Oncology Research & Education on 2007-02-13.