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Therapy Name | Fulvestrant + GDC-0077 + Palbociclib |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Fulvestrant | Faslodex | ICI 182,780 | Hormone - Anti-estrogens 24 | 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). |
GDC-0077 | RO7113755|RG6114|GDC0077|GDC 0077|inavolisib | PIK3CA inhibitor 18 | GDC-0077 inhibits PIK3CA, with selectivity for mutant PIK3CA over wild-type PIK3CA, potentially resulting in increased apoptosis and decreased growth of PIK3CA-mutant tumors (AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 156). | |
Palbociclib | Ibrance | PD0332991 | CDK4/6 Inhibitor 12 | 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). |
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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NCT04191499 | Phase II | Fulvestrant + Palbociclib Fulvestrant + GDC-0077 + Palbociclib | A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 17 |