Therapy Detail
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| Therapy Name | Amcenestrant + Palbociclib |
| Synonyms | |
| Therapy Description | |
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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). | |
| Palbociclib | Ibrance | PD0332991|PD-0332991 | CDK4/6 Inhibitor 14 | Ibrance (palbociclib) is a selective inhibitor of cyclin-dependent kinase 4 (CDK4) and 6 (CDK6) (PMID: 19874578). Ibrance (palbociclib) is approved in combination with an aromatase inhibitor in postmenopausal patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer, and in combination with Faslodex (fulvestrant) in patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer (FDA.gov). |
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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 |
|---|---|---|---|---|---|---|
| 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 |
| NCT04478266 | Phase III | Letrozole + Palbociclib Amcenestrant + Goserelin + Palbociclib Goserelin + Letrozole + Palbociclib Amcenestrant + Palbociclib | SAR439859 Plus Palbociclib as First Line Therapy for Patients With ER(+) HER2(-) Advanced Breast Cancer (AMEERA-5) | Terminated | USA | TUR | POL | NLD | ITA | HUN | GBR | FRA | FIN | ESP | DEU | CZE | CAN | BRA | BGR | BEL | AUT | AUS | ARG | 11 |
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