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

Tracking Information

• First Submitted Date: June 8, 2015
• First Posted Date: June 16, 2015
• Last Update Posted Date: July 30, 2020
• Actual Study Start Date: June 2015
• Actual Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of ESR1 Mutations in Metastatic Breast Cancer
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Metastatic Breast Cancer

Intervention

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

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 10, 2018): 104
• Original Estimated Enrollment (submitted: June 12, 2015): 120
• Actual Study Completion Date: October 2019
• Actual Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02473120
• Other Study ID Numbers: CHB 15.01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Centre Henri Becquerel
• Study Sponsor: Centre Henri Becquerel
• Collaborators: Not Provided

Investigators

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

• PRS Account: Centre Henri Becquerel
• Verification Date: July 2020