Metastatic Breast CancerFMERNCT02473120
Study of ESR1 Mutations in Metastatic Breast Cancer
A study testing Determination of ESR1 mutations in people with Metastatic Breast Cancer, run by Centre Henri Becquerel at 1 site in France.
Trial summary
The purpose of the study is to determine the frequency ESR1 mutations by Digital PCR in patient with metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Determination of ESR1 mutations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- No inform consent signed
- Patient under guardianship, curatorship
- Psychosocial disorder
- No affiliated or beneficiary of a social benefit system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of ESR1 Mutations by Digital PCR During Aromatase Inhibitor Treatment 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.
Read the 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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Determination of ESR1 mutations
- Keywords
- metastatic, ESR1, aromatase inhibitor, breast cancer
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of ESR1 mutationsBiological
Blood sample prelevement. Plasma issued from patient with metastatic breast cancer will be analysed at progression by Digital PCR to detect ESR1 mutations
| Study group | Role | What they receive |
|---|---|---|
| Determination of ESR1 mutations | Experimental | Blood sample will be collected every 3 months during two years to determine ESR1 mutations Receives: Biological: Determination of ESR1 mutations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of ESR1 mutations
Determination of the frequency of ESR1 mutation in patient who have a clinical and/or a radiological progression disease
Measured: up to 24 months
Secondary outcomes (2)
Frequency of progression without ESR1 mutations
Determination of frequency of patient with a progression disease and without any ESR1 mutations
Measured: up to 24 months
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
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Perdrix, MD, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473120
- Sponsor's protocol ID
- CHB 15.01
- Acronym
- FMER
- Status last verified
- Jul 2020
- First submitted
- 8 Jun 2015
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32466779
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of ESR1 Mutations by Digital PCR During Aromatase Inhibitor Treatment in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT02473120
- Acronym / sponsor ID
- FMER / CHB 15.01
- Conditions
- Metastatic Breast Cancer
- Keywords
- metastatic, ESR1, aromatase inhibitor, breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 16 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Determination of ESR1 mutations | Experimental | Biological: Determination of ESR1 mutationsBlood sample will be collected every 3 months during two years to determine ESR1 mutations |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- No inform consent signed
- Patient under guardianship, curatorship
- Psychosocial disorder
- No affiliated or beneficiary of a social benefit system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determination of ESR1 mutationsBlood sample prelevement. Plasma issued from patient with metastatic breast cancer will be analysed at progression by Digital PCR to detect ESR1 mutations | Biological | Determination of ESR1 mutations |
Primary outcome
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
2 secondary outcomes
Frequency of progression without ESR1 mutations
Time frame: up to 24 months
Time between introduction of aromatase inhibitor and detection of ESR1 mutations
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Derived from this study: PubMed 32466779Clatot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Perdrix, MD principal investigator
Centre Henri Becquerel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Determination of ESR1 mutations in people with Metastatic Breast Cancer, run by Centre Henri Becquerel at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of ESR1 mutations (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02473120, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.