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
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Biological: Determination of ESR1 mutations||Not Applicable|
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)|
|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|
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
- 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
- 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
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
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Principal Investigator:||Anne Perdrix, MD||Centre Henri Becquerel|