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Completed

NCT Number: NCT02473120

Study of ESR1 Mutations in Metastatic Breast Cancer

The purpose of the study is to determine the frequency ESR1 mutations by Digital PCR in patient with metastatic breast cancer.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Henri Becquerel

Rouen, 76038, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Determination of ESR1 mutations

Biological

Blood sample prelevement. Plasma issued from patient with metastatic breast cancer will be analysed at progression by Digital PCR to detect ESR1 mutations

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Official study title

Determination of ESR1 Mutations by Digital PCR During Aromatase Inhibitor Treatment in Metastatic Breast Cancer

Acronym: FMER

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 16, 2015
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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