Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to determine the frequency ESR1 mutations by Digital PCR in patient with metastatic breast cancer.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Determination of ESR1 mutations | Experimental | Blood sample will be collected every 3 months during two years to determine ESR1 mutations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of ESR1 mutations | Determination of the frequency of ESR1 mutation in patient who have a clinical and/or a radiological progression disease | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of progression without ESR1 mutations | Determination of frequency of patient with a progression disease and without any ESR1 mutations | up to 24 months |
| Time between introduction of aromatase inhibitor and detection of ESR1 mutations |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anne Perdrix, MD | Centre Henri Becquerel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Henri Becquerel | Rouen | 76038 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32466779 | Derived | Clatot F, Perdrix A, Beaussire L, Lequesne J, Levy C, Emile G, Bubenheim M, Lacaille S, Calbrix C, Augusto L, Guillemet C, Alexandru C, Fontanilles M, Sefrioui D, Burel L, Guenot 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Time between introduction of aromatase inhibitor and detection of ESR1 mutations by digital PCR
| up to 24 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |