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

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00415285
• Other study ID #: EU822-03
• Status: Recruiting
• Phase: Phase 2
• First received: December 20, 2006
• Last updated: February 12, 2007
• Start date: December 2006

Study information

• Verified date: February 2007
• Source: Georgia Center for Oncology Research & Education
• Contact: Rita Johnson
• Phone: 404-778-7777
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Docetaxel

• Capecitabine

• Docetaxel/Capecitabine

Locations

Country	Name	City	State
United States	Emory Crawford Long Hospital	Atlanta	Georgia
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Georgia Center for Oncology Research & Education	Sanofi

Country where clinical trial is conducted

United States, 

External Links

•   Georgia Center for Oncology Research and Education
•   Winship Cancer Institute