Back to resultsStudy of ESR1 Mutations in Metastatic Breast Cancer (FMER)
Primary Purpose
Metastatic Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Determination of ESR1 mutations
Sponsored by
About this trial
This is an interventional other trial for Metastatic Breast Cancer focused on measuring metastatic, ESR1, aromatase inhibitor, breast cancer
Eligibility 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
Sites / Locations
- Centre Henri Becquerel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Determination of ESR1 mutations
Arm Description
Blood sample will be collected every 3 months during two years to determine ESR1 mutations
Outcomes
Primary Outcome Measures
Frequency of ESR1 mutations
Determination of the frequency of ESR1 mutation in patient who have a clinical and/or a radiological progression disease
Secondary Outcome Measures
Frequency of progression without ESR1 mutations
Determination of frequency of patient with a progression disease and without any ESR1 mutations
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02473120
Brief Title
Study of ESR1 Mutations in Metastatic Breast Cancer
Acronym
FMER
Official Title
Determination of ESR1 Mutations by Digital PCR During Aromatase Inhibitor Treatment in Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
October 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
metastatic, ESR1, aromatase inhibitor, breast cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Determination of ESR1 mutations
Arm Type
Experimental
Arm Description
Blood sample will be collected every 3 months during two years to determine ESR1 mutations
Intervention Type
Biological
Intervention Name(s)
Determination of ESR1 mutations
Intervention Description
Blood sample prelevement. Plasma issued from patient with metastatic breast cancer will be analysed at progression by Digital PCR to detect ESR1 mutations
Primary Outcome Measure Information:
Title
Frequency of ESR1 mutations
Description
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 Outcome Measure Information:
Title
Frequency of progression without ESR1 mutations
Description
Determination of frequency of patient with a progression disease and without any ESR1 mutations
Time Frame
up to 24 months
Title
Time between introduction of aromatase inhibitor and detection of ESR1 mutations
Description
Time between introduction of aromatase inhibitor and detection of ESR1 mutations by digital PCR
Time Frame
up to 24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Perdrix, MD
Organizational Affiliation
Centre Henri Becquerel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
32466779
Citation
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.
Results Reference
derived
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Study of ESR1 Mutations in Metastatic Breast Cancer
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