Clinical trial NCT02473120: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Breast Cancer
Keywords: metastatic
ESR1
aromatase inhibitor
breast cancer
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2015-06-16
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Frequency of ESR1 mutations
timeFrame: up to 24 months
Secondary outcomes:
measure: Frequency of progression without ESR1 mutations
timeFrame: up to 24 months
measure: Time between introduction of aromatase inhibitor and detection of ESR1 mutations
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Centre Henri Becquerel
name: Anne Perdrix, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.