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Therapy Name | Giredestrant + Inavolisib |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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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). | |
Inavolisib | Itovebi | GDC-0077|RO7113755|RG6114|GDC0077|GDC 0077 | PIK3CA inhibitor 24 | Itovebi (inavolisib) inhibits PIK3CA, with selectivity for mutant PIK3CA over wild-type PIK3CA, potentially resulting in increased apoptosis and decreased growth of PIK3CA-mutant tumors (PMID: 36455032). Itovebi (inavolisib) in combination with Ibrance (palbociclib) and Faslodex (fulvestrant) is FDA-approved for use in patients with endocrine-resistant, hormone receptor (HR)-positive, ERBB2 (HER2)-negative, locally advanced or metastatic breast cancer harboring PIK3CA mutations (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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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 |
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 |