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Molecular Profile PTEN inact mut
Therapy Ipatasertib + Paclitaxel
Indication/Tumor Type triple-receptor negative breast cancer
Response Type no benefit

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
PTEN inact mut triple-receptor negative breast cancer no benefit Ipatasertib + Paclitaxel Phase III Actionable In a Phase III trial (IPATunity130), the addition of Ipatasertib (GDC-0068) to treatment with Abraxane (paclitaxel) did not result in improved median progression-free survival (7.4 mo vs 6.1 mo, HR=1.02, p=0.92), median overall survival (24.4 mo vs 24.9 mo, HR=1.08), objective response rate (39% vs 35%) or clinical benefit rate (47% vs 45%) in patients with metastatic triple-negative breast cancer harboring PIK3CA and/or AKT activating mutations or PTEN inactivating mutations (PMID: 39058425; NCT03337724). 39058425
PTEN inact mut triple-receptor negative breast cancer no benefit Ipatasertib + Paclitaxel Phase II Actionable In a Phase II trial (LOTUS), Ipatasertib (GDC-0068) in combination with Abraxane (paclitaxel) resulted a median progression free survival of 6.2 vs 4.9 months with placebo in triple-receptor negative breast cancer patients harboring activating mutations in PIK3CA or AKT1, or inactivating mutations in PTEN (PMID: 28800861; NCT02162719). 28800861
PubMed Id Reference Title Details
(28800861) Ipatasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer (LOTUS): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Full reference...
(39058425) Ipatasertib plus Paclitaxel for Patients with PIK3CA/AKT1/PTEN-Altered Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer in the IPATunity130 Phase III Trial. Full reference...