Therapy Detail
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| Therapy Name | Giredestrant + Palbociclib |
| 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). | |
| 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 |
|---|---|---|---|---|---|---|
| NCT03332797 | Phase I | Giredestrant + Palbociclib Giredestrant | A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer | Active, not recruiting | USA | GBR | ESP | AUS | 1 |
| NCT04546009 | Phase III | Letrozole + Palbociclib Giredestrant + Palbociclib | A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer) | Active, not recruiting | USA | TUR | POL | NZL | ITA | ISR | HUN | GRC | GBR | FRA | ESP | DNK | DEU | CAN | BRA | BEL | AUT | AUS | ARG | 11 |
| 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 |
| NCT04436744 | Phase II | Giredestrant + Palbociclib Anastrozole + Palbociclib | A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of GDC-9545 Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer | Completed | USA | POL | HUN | ESP | DEU | BRA | AUS | 4 |
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