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

Sponsor

Georgia Center for Oncology Research & Education (Other)

Overall Status

Unknown status

CT.gov ID

NCT00415285

Collaborator

Sanofi (Industry)

100

Enrollment

Locations

33.3

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms	Drug: Docetaxel Drug: Capecitabine Drug: Docetaxel/Capecitabine	Phase 2

Detailed Description

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Grady Memorial Hospital	Atlanta	Georgia	United States	30303
2	Emory Crawford Long Hospital	Atlanta	Georgia	United States	30308
3	Winship Cancer Institute of Emory University	Atlanta	Georgia	United States	30322