Drugs / Amcenestrant
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05126329 | Nov 2021 → May 2022 | liver disorder | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04940026 | Jun → Aug 2021 | breast cancer | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT03816839 | Mar 2019 → Oct 2020 | breast cancer | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03284957 | Sep 2017 → Nov 2024 | breast cancer | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 23 trials · 1 missed | ||||||
| Phase 2 | NCT04191382 | Feb 2020 → Apr 2021 | breast cancer | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04059484 | Oct 2019 → Feb 2022 | breast cancer | Sanofi | Terminated | Missed primary Stop: Business |
| Phase 2 | NCT01042379 | Mar 2010 → Dec 2030 expected | HER2 positive breast carcinoma, angiosarcoma, female breast carcinoma, hormone receptor-positive breast cancer +1 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 32 trials · 1 missed | ||||||
| Phase 3 | NCT05128773 | Feb → Oct 2022 | breast cancer | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04478266 | Oct 2020 → Jun 2022 | breast cancer | Sanofi | Terminated | Missed primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2022-08-17 | Sanofi | Results Press Release: Sanofi provides update on amcenestrant clinical development program sanofi.com ↗
An Independent Data Monitoring Committee (IDMC) found that amcenestrant in combination with palbociclib did not meet the prespecified boundary for continuation in comparison with the control arm and recommended stopping the trial. |
| 2022-03-14 | Sanofi | Results Press Release: Sanofi provides update on Phase 2 study evaluating amcenestrant in ER+/HER2- advanced or metastatic breast cancer sanofi.com ↗
The Phase 2 AMEERA-3 clinical trial evaluating amcenestrant, an investigational optimized oral selective estrogen receptor degrader (SERD), did not meet its primary endpoint of improving progression-free survival (PFS) as assessed by an independent central review. |
| 2021-05-19 | Sanofi | Results Sanofi to showcase data from its transformative oncology pipeline at 2021 ASCO Meeting sanofi.com ↗
Early clinical data for investigational oral selective estrogen receptor (SERD), amcenestrant, show potential to become a new endocrine backbone therapy in ER+ HER2- breast cancer |
| 2021-05-19 | Sanofi | Results Early amcenestrant data featured at ASCO support its potential to become a new endocrine backbone therapy for ER+/HER2- breast cancer sanofi.com ↗
Amcenestrant, an investigational oral selective estrogen receptor degrader (SERD), achieved an objective response rate of 34% and a clinical benefit rate of 74% in Phase 1 study (AMEERA-1) in combination with palbociclib |
All press releases naming this drug 5 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Amcenestrant | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01042379 ↗ |
| Known as | SAR439859 | “Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer” NCT04059484 ↗4“Amcenestrant (SAR439859), 200mg QD, p.o.” NCT01042379 ↗ “Drug: Amcenestrant (SAR439859)” NCT04191382 ↗ “Amcenestrant (SAR439859)” NCT03816839 ↗ |
| Action | Deplete | “Estrogen receptor alpha degrader” CHEMBL4475463 ↗ |
| Action | Inhibit | “Paired tumor biopsy and cell-free DNA analyses revealed ER inhibition and degradation” PMID 35840573 ↗ Jul 2022 |
| Modality | Other / unclassified | “selective estrogen receptor degrader (SERD)” PMID 36977973 ↗ Mar 2023 |
| Route | Oral | “Amcenestrant (SAR439859), 200mg QD, p.o.” NCT01042379 ↗ |
| Target | ESR1 | “Estrogen receptor alpha degrader” CHEMBL4475463 ↗ |