Study of ESR1 Mutations in Metastatic Breast Cancer (FMER)

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

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

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Biological: Determination of ESR1 mutations

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76038
    • Centre Henri Becquerel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Determination of ESR1 mutations; Blood sample will be collected every 3 months during two years to determine ESR1 mutations	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of progression without ESR1 mutations	Determination of frequency of patient with a progression disease and without any ESR1 mutations	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	up to 24 months

Collaborators and Investigators

• Sponsor: Centre Henri Becquerel
• Investigators: Principal Investigator: Anne Perdrix, MD, Centre Henri Becquerel

Publications and helpful links

General Publications

• Clatot F, Perdrix A, Beaussire L, Lequesne J, Levy C, Emile G, Bubenheim M, Lacaille S, Calbrix C, Augusto L, Guillemet C, Alexandru C, Fontanilles M, Sefrioui D, Burel L, Guenot S, Richard D, Sarafan-Vasseur N, Di Fiore F. Risk of early progression according to circulating ESR1 mutation, CA-15.3 and cfDNA increases under first-line anti-aromatase treatment in metastatic breast cancer. Breast Cancer Res. 2020 May 28;22(1):56. doi: 10.1186/s13058-020-01290-x.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: June 8, 2015
• First Submitted That Met QC Criteria: June 12, 2015
• First Posted (Estimate): June 16, 2015

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: breast cancer; metastatic; aromatase inhibitor; ESR1
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CHB 15.01