Study of ESR1 Mutations in Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

— FMER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02473120
• Other study ID #: CHB 15.01
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: October 2019

Study information

• Verified date: July 2020
• Source: Centre Henri Becquerel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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

Locations

Country	Name	City	State
France	Centre Henri Becquerel	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Frequency of progression without ESR1 mutations	Determination of frequency of patient with a progression disease and without any ESR1 mutations	up to 24 months
Secondary	Time between introduction of aromatase inhibitor and detection of ESR1 mutations	Time between introduction of aromatase inhibitor and detection of ESR1 mutations by digital PCR	up to 24 months