NCT01440413

Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, non-randomized study which aims to evaluate the response to a neoadjuvant chemotherapy according to the the antitumor immune response in localized breast cancer. 40 patients will be enrolled in the study. They will receive chemotherapy : 3 or 4 anthracycline cycles or 3 or 4 FEC-100 cycles followed by 3 or 4 taxane cycles. Trastuzumab will be added to taxane for HER2+/Neu+ patients. Then, patients will be operated and receive an adjuvant treatment which will both depend on the investigator's appreciation. Blood sample will be collected on the first day of the first chemotherapy cycle, on the first day of the third cycle, on surgery, 6 months after the surgery and in case of relapse. Tumor sample will be collected on diagnosis as much as possible and on surgery. Patients will be followed during 5 years.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Blood and tumor sample	Blood samples will be collected on the first day of the first cycle of chemotherapy (before injection of chemotherapy), on the first day of the third cycle (before injection of chemotherapy), on day of surgery and 6 months after surgery and in case of relapse. Tumor samples will be collected on diagnosis, on surgery and on the first day of the third chemotherapy course (optional).

Timeline

• Start date: 2011-12-01
• Primary completion: 2018-12-01
• Completion: 2020-12-01
• First posted: 2011-09-26
• Last updated: 2020-03-24

Locations

2 sites across 1 country: France