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|Molecular Profile||Indication/Tumor Type||Response Type||Relevant Treatment Approaches||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|ERBB2 pos PIK3CA H1047R||Her2-receptor positive breast cancer||predicted - sensitive||Neratinib||Phase III||Actionable||In a Phase III trial (ExteNET), Nerlynx (neratinib) treatment resulted in improved 5-year invasive disease-free survival (92.4% vs 84.5%, HR=0.41, p=0.028) and clinical benefit (HR=0.40, p=0.041) compared to placebo in patients with ERBB2 (HER2)-positive early breast cancer who completed trastuzumab-based adjuvant therapy, and harbored PIK3CA amplification (n=61) or mutations (n=210), including H1047R (n=110), E542K (n=18), and E545K/D (n=82) (PMID: 30867034; NCT00878709).||30867034|
|ERBB2 pos PIK3CA H1047R||Her2-receptor positive breast cancer||sensitive||Ado-trastuzumab emtansine||Preclinical - Cell line xenograft||Actionable||In a preclinical study, Kadcyla (trastuzumab emtansine) inhibited survival of Herceptin (trastuzumab)-resistant ERBB2 (HER2) positive breast cancer cells harboring PIK3CA H1047R in culture, and induced tumor regression in cell line xenograft models (PMID: 26920887).||26920887|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|