Clinical trial · Interventional
Study of ESR1 Mutations in Metastatic Breast Cancer
Determination of ESR1 Mutations by Digital PCR During Aromatase Inhibitor Treatment in Metastatic Breast Cancer
NCT02473120CI-TRIAL-00046288FMERcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to determine the frequency ESR1 mutations by Digital PCR in patient with metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Determination of ESR1 mutations | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Determination of ESR1 mutations
- description
- Blood sample will be collected every 3 months during two years to determine ESR1 mutations
- interventionNames
- Biological: Determination of ESR1 mutations
Primary outcomes (1)
- measure
- Frequency of ESR1 mutations
- timeFrame
- up to 24 months
- description
- Determination of the frequency of ESR1 mutation in patient who have a clinical and/or a radiological progression disease
Secondary outcomes (2)
- measure
- Frequency of progression without ESR1 mutations
- timeFrame
- up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDClatot 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. PMID 32466779