ArticleFrontiers in pharmacology2025
Pharmacokinetics, safety and tolerability of ipatasertib in combination with palbociclib and fulvestrant in patients with advanced breast cancer in a phase Ib study.
Article in Frontiers in pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04060862 (A Phase Ib/III Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer), which is not on this map. Cited by 1 paper.
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A Phase Ib/III Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer
Who cites it
1 citing paper in PubMed.
- Transcription factor targeting strategies in cancer: mechanisms, challenges and cutting-edge progress.Acta pharmacologica Sinica · 2026Review
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7 authors.
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Abstract
Introduction: Ipatasertib is a potent, highly selective, small molecule AKT inhibitor that has been evaluated in combination with palbociclib and fulvestrant for the treatment of hormone receptor-positive (HR+) human epidermal growth factor receptor two negative (HER2-) breast cancer. Ipatasertib is a sensitive CYP3A4 substrate and is extensively metabolized to its major metabolite, M1 (G-037720). Ipatasertib is also a mild to moderate CYP3A inhibitor Methods: The study reported herein is a Phase Ib clinical trial that aimed to evaluate the safety and pharmacokinetics (PK) of 300 mg ipatasertib in combination with palbociclib and fulvestrant (NCT04060862). The ipatasertib and M1 PK at steady state as a single agent were compared to that in combination with palbociclib and fulvestrant to evaluate the magnitude of DDI between ipatasertib and palbociclib. Results: The PK analysis showed that the area under the concentration-time curve from time 0-24 h at steady state (AUC Conclusion: This study indicated a DDI between ipatasertib and palbociclib, leading to increased ipatasertib exposure. The combination regimen of ipatasertib 300 mg with palbociclib and fulvestrant had a notable and manageable safety profile, that is generally consistent with the known risks of each individual study drugs in patients with HR + HER2-breast cancer.
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