Study of ESR1 Mutations in Metastatic Breast Cancer
FMER
Determination of ESR1 Mutations by Digital PCR During Aromatase Inhibitor Treatment in Metastatic Breast Cancer
1 other identifier
interventional
104
1 country
1
Brief Summary
The purpose of the study is to determine the frequency ESR1 mutations by Digital PCR in patient with metastatic breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 8, 2015
CompletedFirst Posted
Study publicly available on registry
June 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedJuly 30, 2020
July 1, 2020
4.3 years
June 8, 2015
July 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Frequency of progression without ESR1 mutations
up to 24 months
Time between introduction of aromatase inhibitor and detection of ESR1 mutations
up to 24 months
Study Arms (1)
Determination of ESR1 mutations
EXPERIMENTALBlood sample will be collected every 3 months during two years to determine ESR1 mutations
Interventions
Blood sample prelevement. Plasma issued from patient with metastatic breast cancer will be analysed at progression by Digital PCR to detect ESR1 mutations
Eligibility Criteria
You may qualify if:
- 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
- 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)
You may not qualify if:
- No inform consent signed
- Patient under guardianship, curatorship
- Psychosocial disorder
- No affiliated or beneficiary of a social benefit system
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Henri Becquerel
Rouen, 76038, France
Related Publications (1)
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.
PMID: 32466779DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Perdrix, MD
Centre Henri Becquerel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2015
First Posted
June 16, 2015
Study Start
June 1, 2015
Primary Completion
September 1, 2019
Study Completion
October 1, 2019
Last Updated
July 30, 2020
Record last verified: 2020-07