Study of ESR1 Mutations in Metastatic Breast Cancer (FMER)

• ClinicalTrials.gov Identifier: NCT02473120
• Recruitment Status: Completed
• First Posted: June 16, 2015
• Last Update Posted: July 30, 2020
• Sponsor: Centre Henri Becquerel
• Information provided by (Responsible Party): Centre Henri Becquerel

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Metastatic Breast Cancer	Biological: Determination of ESR1 mutations	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 104 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Determination of ESR1 Mutations by Digital PCR During Aromatase Inhibitor Treatment in Metastatic Breast Cancer
• Actual Study Start Date: June 2015
• Actual Primary Completion Date: September 2019
• Actual Study Completion Date: October 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Frequency of ESR1 mutations [ Time Frame: 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 :

1. Frequency of progression without ESR1 mutations [ Time Frame: up to 24 months ]
   Determination of frequency of patient with a progression disease and without any ESR1 mutations
2. Time between introduction of aromatase inhibitor and detection of ESR1 mutations [ Time Frame: up to 24 months ]
   Time between introduction of aromatase inhibitor and detection of ESR1 mutations by digital PCR

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

France

Centre Henri Becquerel

Rouen, France, 76038

Sponsors and Collaborators

Centre Henri Becquerel

Investigators

• Principal Investigator: Anne Perdrix, MD; Centre Henri Becquerel

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Clatot F, Perdrix A, Beaussire L, Lequesne J, Lévy C, Emile G, Bubenheim M, Lacaille S, Calbrix C, Augusto L, Guillemet C, Alexandru C, Fontanilles M, Sefrioui D, Burel L, Guénot 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.

• Responsible Party: Centre Henri Becquerel
• ClinicalTrials.gov Identifier: NCT02473120
• Other Study ID Numbers: CHB 15.01
• First Posted: June 16, 2015
• Last Update Posted: July 30, 2020
• Last Verified: July 2020

Keywords provided by Centre Henri Becquerel:

metastatic; ESR1; aromatase inhibitor; breast cancer

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases