Study of ESR1 Mutations in Metastatic Breast Cancer

Centre Henri Becquerel104 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

104

Conditions

Metastatic Breast Cancer

Interventions

Determination of ESR1 mutationsBIOLOGICAL

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

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Centre Henri Becquerel

Rouen, France

Outcomes

Primary Outcomes

Frequency of ESR1 mutations

Determination of the frequency of ESR1 mutation in patient who have a clinical and/or a radiological progression disease

Time frame: up to 24 months

Secondary Outcomes

Frequency of progression without ESR1 mutations

Determination of frequency of patient with a progression disease and without any ESR1 mutations

Time frame: up to 24 months

Time between introduction of aromatase inhibitor and detection of ESR1 mutations

Time between introduction of aromatase inhibitor and detection of ESR1 mutations by digital PCR

Time frame: up to 24 months

Data from ClinicalTrials.gov

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