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Association details:
| Biomarker: | PTEN mutation |
|---|---|
| Cancer: | Triple Negative Breast Cancer |
| Drug: | ipatasertib (RG7440) (PI3K inhibitor, AKT inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
GS3-04 Double-blind placebo (PBO)-controlled randomized phase III trial evaluating first-line ipatasertib (IPAT) combined with paclitaxel (PAC) for PIK3CA/AKT1/PTEN-altered locally advanced unresectable or metastatic triple-negative breast cancer (aTNBC): primary results from IPATunity130 Cohort A
Published date:
10/12/2020
Excerpt:
CONTRADICTING EVIDENCE: Treatment with ipatasertib plus paclitaxel (Abraxane) failed to show a significant improvement in progression-free survival versus placebo plus paclitaxel in patients with PIK3CA/AKT1/PTEN-altered locally advanced, unresectable, or metastatic triple-negative breast cancer.
Secondary therapy:
albumin-bound paclitaxel
Trial ID:
Source:
Title:
A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors (LOTUS)
Excerpt:
PFS in Participants With Phosphatidylinositol-4,5-bisphosphate 3-kinase Catalytic Subunit Alpha (PIK3CA)/ Protein Kinase B (AKT1)/ PTEN-altered Tumors...
Trial ID:
Source:
Title:
A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer (IPATunity130)
Excerpt:
Confirmation of biomarker eligibility using an appropriately validated molecular assay at a diagnostic laboratory, Clinically Laboratory Improvement Amendments (CLIA) or equivalently accredited i.e., valid results from either central testing or local testing of tumor tissue or blood demonstrating PIK3CA/AKT1/PTEN-altered status...
Trial ID:
Less C2 evidence
Source:
Title:
139O - Final results of the double-blind placebo (PBO)-controlled randomised phase II LOTUS trial of first-line ipatasertib (IPAT) + paclitaxel (PAC) for inoperable locally advanced/metastatic triple-negative breast cancer (mTNBC)
Published date:
05/23/2020
Excerpt:
In the ITT population, median OS was numerically longer in the IPAT + PAC arm (Table). Similarly, median OS favoured IPAT + PAC vs PBO + PAC in the PTEN-low (n=48; 23.1 vs 15.8 mo) and PIK3CA/AKT1/PTEN-altered (n=42; 25.8 vs 22.1 mo) subgroups.
Secondary therapy:
paclitaxel
Trial ID:
