Therapy Detail
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| Therapy Name | Fulvestrant + Inavolisib |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Fulvestrant | Faslodex | ICI 182,780 | Hormone - Anti-estrogens 29 | Faslodex (fulvestrant) is a competitive inhibitor of estrogen that binds and deforms estrogen receptors, and causes inhibition of growth in cultured estrogen-sensitive breast cancer cells and is FDA approved for use in patients with hormone receptor-positive breast cancer (FDA.gov). |
| 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). |
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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 |
|---|---|---|---|---|---|---|
| NCT03006172 | Phase I | Inavolisib + Letrozole + Palbociclib Inavolisib Fulvestrant + Inavolisib Inavolisib + Letrozole | To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer | Active, not recruiting | USA | GBR | FRA | ESP | CAN | 0 |
| NCT05646862 | Phase III | Alpelisib + Fulvestrant Fulvestrant + Inavolisib | A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy (INAVO121) | Recruiting | USA | TUR | POL | ITA | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS | ARG | 6 |
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