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Study of ESR1 Mutations in Metastatic Breast Cancer (FMER)

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ClinicalTrials.gov Identifier: NCT02473120
Recruitment Status : Active, not recruiting
First Posted : June 16, 2015
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Henri Becquerel

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
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
Study Start Date : June 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473120


Locations
France
Centre Henri Becquerel
Rouen, France, 76038
Sponsors and Collaborators
Centre Henri Becquerel
Investigators
Principal Investigator: Anne Perdrix, MD Centre Henri Becquerel

Responsible Party: Centre Henri Becquerel
ClinicalTrials.gov Identifier: NCT02473120     History of Changes
Other Study ID Numbers: CHB 15.01
First Posted: June 16, 2015    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018

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
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs