NCT00540800

BREAST-10: Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer

Phase III Multicenter Study of the Effects on Quality of Life of Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: Female
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

Some chemotherapies, including docetaxel, are better tolerated and just as effective when giving the dose weekly rather than on an every three week basis. The purpose of this study is to compare 2 schedules of combination chemotherapy with docetaxel for the effects on quality of life. Standard every three week chemotherapy will be compared with weekly chemotherapy for metastatic or locally advanced breast cancer.

Detailed description

Patients with locally advanced breast cancer and patients with metastatic breast cancer who have not previously received an anthracycline will be treated with docetaxel and epirubicin. Patients with metastatic breast cancer who have already received anthracyclines will be treated with docetaxel and capecitabine. All patients will be randomized to receive their treatment either on an every three week schedule, or on a weekly schedule.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	docetaxel	given in combination with epirubicin or capecitabine
DRUG	epirubicin	for patients with locally advanced breast cancer, or metastatic breast cancer not previously treated with anthracyclines
DRUG	capecitabine	for metastatic breast cancer patients previously treated with anthracyclines

Timeline

• Start date: 2004-02-01
• Primary completion: 2009-09-01
• Completion: 2009-12-01
• First posted: 2007-10-08
• Last updated: 2016-01-14

Locations

3 sites across 1 country: Italy