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Study of ESR1 Mutations in Metastatic Breast Cancer (FMER)

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

Tracking Information
First Submitted Date  ICMJE June 8, 2015
First Posted Date  ICMJE June 16, 2015
Last Update Posted Date July 30, 2020
Actual Study Start Date  ICMJE June 2015
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2015)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of ESR1 Mutations in Metastatic Breast Cancer
Official Title  ICMJE Determination of ESR1 Mutations by Digital PCR During Aromatase Inhibitor Treatment in Metastatic Breast Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Determination of ESR1 mutations
Blood sample will be collected every 3 months during two years to determine ESR1 mutations
Intervention: Biological: Determination of ESR1 mutations
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2018)
104
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2015)
120
Actual Study Completion Date  ICMJE October 2019
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02473120
Other Study ID Numbers  ICMJE CHB 15.01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Henri Becquerel
Study Sponsor  ICMJE Centre Henri Becquerel
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anne Perdrix, MD Centre Henri Becquerel
PRS Account Centre Henri Becquerel
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP