Therapy Detail
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| Therapy Name | Giredestrant + Ribociclib |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Giredestrant | RG6171|GDC9545|GDC 9545|GDC-9545) | Hormone - Anti-estrogens 29 | Giredestrant (GDC-9545) is a selective estrogen receptor degrader (SERD) that prevents cell proliferation of ER-positive cells (Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020) 1023-1023). | |
| Ribociclib | Kisqali | LEE011|LEE-011|LEE 011 | CDK4/6 Inhibitor 14 | Kisqali (ribociclib) is a dual CDK4/6 inhibitor, which may induce cell cycle arrest and reduce proliferation in cancer cells (PMID: 24045179). Kisqali (ribociclib) is FDA-approved in combination with an aromatase inhibitor in women with hormone receptor-positive, ERBB2 (HER2)-negative breast cancer, and in combination with Faslodex (fulvestrant) in postmenopausal women with hormone receptor-positive, ERBB2 (HER2)-negative 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 |
|---|---|---|---|---|---|---|
| NCT06065748 | Phase III | Fulvestrant + Palbociclib Abemaciclib + Fulvestrant Giredestrant + Ribociclib Giredestrant + Palbociclib Abemaciclib + Giredestrant Fulvestrant + Ribociclib | A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) | Recruiting | USA | SVN | POL | NZL | ITA | ISR | HUN | GRC | FRA | FIN | ESP | DEU | CAN | BRA | BEL | AUT | AUS | ARG | 15 |
| NCT04802759 | Phase Ib/II | Abemaciclib + Giredestrant Giredestrant + Ipatasertib Giredestrant Everolimus + Giredestrant Giredestrant + Inavolisib Giredestrant + Ribociclib | A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer | Recruiting | USA | ISR | ESP | AUS | 1 |
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