Therapy Detail
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| Therapy Name | Amcenestrant |
| Synonyms | |
| Therapy Description |
Amcenestrant (SAR439859) is a selective estrogen receptor degrader that down-regulates ER expression and signaling, resulting in tumor cell growth inhibition (Cancer Res 2017;77(4 Suppl):Abstract nr P3-04-05, PMID: 31721572). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Amcenestrant | SAR-439859|SAR 439859|SAR439859 | Hormone - Anti-estrogens 29 | Amcenestrant (SAR439859) is a selective estrogen receptor degrader that down-regulates ER expression and signaling, resulting in tumor cell growth inhibition (Cancer Res 2017;77(4 Suppl):Abstract nr P3-04-05, PMID: 31721572). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04059484 | Phase II | Amcenestrant | Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer (AMEERA-3) | Active, not recruiting | USA | TUR | POL | LVA | ITA | ISR | GRC | FRA | ESP | CZE | CAN | BRA | BEL | AUS | ARG | 8 |
| NCT05101564 | Phase II | Amcenestrant Alpelisib Infigratinib Tamoxifen Letrozole Amcenestrant + Letrozole | Umbrella Trial Testing Integrative Subtype Targeted Therapeutics in Estrogen Receptor Positive, HER2-Negative Breast Cancer | Active, not recruiting | USA | 0 |
| NCT04191382 | Phase II | Letrozole Amcenestrant | Phase 2 Window Study of SAR439859 Versus Letrozole in ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer (AMEERA-4) | Terminated | USA | ITA | FRA | ESP | BEL | 4 |
| NCT05128773 | Phase III | Tamoxifen Amcenestrant | Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity (AMEERA-6) | Terminated | 2 | |
| NCT03284957 | Phase Ib/II | Amcenestrant Alpelisib + Amcenestrant Amcenestrant + Palbociclib Abemaciclib + Amcenestrant Amcenestrant + Everolimus | Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer (AMEERA-1) | Active, not recruiting | USA | POL | ITA | GBR | FRA | ESP | CZE | CAN | BEL | 1 |
| NCT01042379 | Phase II | Trilaciclib Trastuzumab Duocarmazine Cyclophosphamide + Doxorubicin Cemiplimab Amcenestrant Abemaciclib + Amcenestrant Carboplatin + Dostarlimab-gxly + HM30181A + Paclitaxel + Trastuzumab Amcenestrant + Letrozole Carboplatin + Dostarlimab-gxly + HM30181A + Paclitaxel Pertuzumab + Trastuzumab + Trilaciclib Paclitaxel + Trastuzumab Pertuzumab + Trastuzumab Cemiplimab + Fianlimab | I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (I-SPY) | Recruiting | USA | 0 |
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