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Therapy Name | Amcenestrant + Goserelin + Palbociclib |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Amcenestrant | SAR-439859|SAR 439859|SAR439859 | Hormone - Anti-estrogens 31 | 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). | |
Goserelin | Zoladex | Goserelin acetate | Zoladex (goserelin) is a synthetic analog of lutenizing hormone-releasing hormone, which causes decreased testosterone production in males and decreased estradiol production in females, and is FDA approved for use in prostate carcinoma (FDA.gov). | |
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). |
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 |
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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 |