Study of ESR1 Mutations in Metastatic Breast Cancer

Not Applicable

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Biological: Determination of ESR1 mutations

• Registration Number: NCT02473120
• Lead Sponsor: Centre Henri Becquerel

Brief 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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-08
• Study First Submitted QC: 2015-06-12
• Study First Posted: 2015-06-16
• Primary Completion: 2019-09
• Study Completion: 2019-10
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-29
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 104

Inclusion Criteria

• Woman aged superior to 18 years old
• Inform consent signed
• Metastatic breast cancer or loco-regionnaly advanced breast cancer
• Inoperable
• With an indication to treat with aromatase inhibitor
• Treatment with aromatase inhibitors innitiated at the inclusion or at least 6 months before inclusion with a stable disease
• Without precedent treatment or with treatment by chemotherapy/tamoxifen/faslodex or aromatase inhibitors in a adjuvant treatment and with a time frame of 2 years between last treatment with aromatase inhibitors and metastatic evolution
• Treatment by aromatase inhibitors alone or in combination with a targeted therapy (trastuzumab +/- pertuzumab, bevacizumab, everolimus)

Exclusion Criteria

• No inform consent signed
• Patient under guardianship, curatorship
• Psychosocial disorder
• No affiliated or beneficiary of a social benefit system

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Determination of ESR1 mutations	Determination of ESR1 mutations	Blood sample will be collected every 3 months during two years to determine ESR1 mutations

Primary Outcome Measures

Name	Time	Method
Frequency of ESR1 mutations	up to 24 months	Determination of the frequency of ESR1 mutation in patient who have a clinical and/or a radiological progression disease

Secondary Outcome Measures

Name	Time	Method
Time between introduction of aromatase inhibitor and detection of ESR1 mutations	up to 24 months	Time between introduction of aromatase inhibitor and detection of ESR1 mutations by digital PCR
Frequency of progression without ESR1 mutations	up to 24 months	Determination of frequency of patient with a progression disease and without any ESR1 mutations

Trial Locations

Locations (1)

Centre Henri Becquerel; 🇫🇷 Rouen, France