Clinical trials
Full profile accessFollow clinical development from study design and recruitment through results.
- Trial phase
- Status
- Readouts
Drug intelligence / Profile preview
Palbociclib + gedatolisib is a combination therapy investigated primarily for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. Palbociclib is a selective small molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6), which blocks cell cycle progression in tumor cells. Gedatolisib is a dual inhibitor targeting both the phosphatidylinositol 3-kinase (PI3K) and mammalian target of rapamycin (mTOR) pathways, both of which are central to cell proliferation and survival. The combination aims to simultaneously inhibit cell cycle progression and critical oncogenic signaling, particularly useful in overcoming or delaying acquired resistance to CDK4/6 inhibitors. Clinical trials have shown promising response rates and manageable toxicity, with the most common adverse events being neutropenia, stomatitis, rash, and hyperglycemia. This combination is under active investigation in Phase 3 studies for HR+/HER2- advanced breast cancer, both in treatment-naive patients and those previously treated with CDK4/6 inhibitors[1][2][3][9][4][5][7].
Beyond the preview
Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.
Follow clinical development from study design and recruitment through results.
Explore development by indication, patient population, and geography.
Trace asset ownership, licensing agreements, and commercial partnerships.
Explore the patent landscape and regulatory exclusivity around an asset.
Compare development programs by target, modality, and indication.
Connect source evidence and development news to your research questions.
See how Gosset can support your research on palbociclib + gedatolisib.