NCT02473120

Study of ESR1 Mutations in Metastatic Breast Cancer

Determination of ESR1 Mutations by Digital PCR During Aromatase Inhibitor Treatment in Metastatic Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Centre Henri Becquerel · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to determine the frequency ESR1 mutations by Digital PCR in patient with metastatic breast cancer.

Detailed description

Breast cancer is the most common cancer in woman. Aromatase inhibitors have demonstrated a real efficacy however a resistance to treatment exists. ESR1 mutations appear like involved in the mechanism of resistance to aromatase inhibitors treatment. The purpose of the study is to determine the frequency ESR1 mutations by Digital PCR in patient with metastatic breast cancer. The significance of the Digital PCR technique will be determined first in plasma issued from healthy volunteers. At the initiation of aromatase inhibitors treatment patient with metastatic breast cancer will be included in the study. During their follow-up visit every 3 months), their status towards their disease will be collected and a plasma will be collected too. When the patient progress clinically or radiologically the plasma concomitant to this progression will be analysed by Digital PCR to detect ESR1 mutations. The patient will be followed during 2 years.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Determination of ESR1 mutations	Blood sample prelevement. Plasma issued from patient with metastatic breast cancer will be analysed at progression by Digital PCR to detect ESR1 mutations

Timeline

• Start date: 2015-06-01
• Primary completion: 2019-09-01
• Completion: 2019-10-01
• First posted: 2015-06-16
• Last updated: 2020-07-30

Locations

1 site across 1 country: France