Therapy Detail
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| Therapy Name | Abemaciclib + Giredestrant |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Abemaciclib | Verzenio | LY2835219 | CDK4/6 Inhibitor 14 | Verzenio (abemaciclib) is a dual CDK4/6 inhibitor, which inhibits Rb1 protein phosphorylation and may induce cell cycle arrest and prevent growth in cancer cells (PMID: 24919854). Verzenio (abemaciclib) is FDA approved as a monotherapy and in combination with Faslodex (fulvestrant) in patients with hormone receptor-positive, ERBB2 (HER2) receptor-negative advanced or metastatic breast cancer, in combination with endocrine therapy as adjuvant treatment for patients with hormone receptor-positive, ERBB2 (HER2) receptor-negative, node-positive, early breast cancer at high risk of recurrence, and in combination with an aromatase inhibitor as initial therapy for patients with hormone receptor-positive, ERBB2 (HER2) receptor-negative advanced or metastatic breast cancer (FDA.gov). |
| Giredestrant | RG6171|GDC9545|GDC 9545|GDC-9545) | Hormone - Anti-estrogens 31 | 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). |
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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 |
|---|---|---|---|---|---|---|
| NCT06259929 | Phase II | Abemaciclib + Giredestrant | NEOadjuvant Abemaciclib and GIredestrant triaL in Patients With ER-positive, HER2-negative Early Breast Cancer (Neo-AGILE) | Recruiting | ITA | 0 |
| NCT07100106 | Phase Ib/II | Abemaciclib + Giredestrant Giredestrant + RGT-419B | A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer | Recruiting | USA | AUS | 0 |
| NCT04486352 | Phase Ib/II | Atezolizumab + Talazoparib Atezolizumab + Ipatasertib Abemaciclib + Giredestrant Inavolisib + Letrozole | A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer (EndoMAP) | Recruiting | USA | 0 |
| 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 |
| 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 | TUR | SVN | ROU | POL | NZL | ITA | ISR | HUN | GRC | FRA | FIN | ESP | DEU | CAN | BRA | BEL | AUT | AUS | ARG | 17 |
| NCT05708235 | Phase II | Giredestrant + Inavolisib Abemaciclib + Giredestrant Giredestrant | A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population (MiRaDoR) | Active, not recruiting | GBR | ESP | 0 |
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