Kazia Therapeutics Expanded Paxalisib Breast Cancer Trial
The clinical study is investigating if the drug can restore sensitivity to existing hormone therapies.
Updated on Sept. 28, 2026 in Cancer
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Kazia Therapeutics has expanded a clinical trial testing the drug paxalisib in patients with HR-positive, HER2-negative breast cancer. The research aims to determine if the treatment can resensitize tumors that have become resistant to CDK4/6 inhibitors.
Why it matters
The study addresses a critical clinical challenge, as many breast cancer patients eventually develop resistance to standard CDK4/6 inhibitor treatments. By combining paxalisib with existing therapies like fulvestrant, researchers hope to improve outcomes for patients with limited options.
The clinical trial is currently enrolling participants in Australia and testing two dosage levels of paxalisib combined with fulvestrant and palbociclib. To date, paxalisib has been administered to more than 550 patients across various brain cancer programs.
The players
Kazia Therapeutics
An oncology-focused biotechnology company that develops innovative therapies for patients with difficult-to-treat cancers.
The details
The ongoing trial evaluates the safety and tolerability of paxalisib when paired with fulvestrant and palbociclib in HR-positive, HER2-negative breast cancer. Researchers are analyzing blood and tissue samples to detect specific biomarkers and mutations that could indicate treatment response.
Timeline
September 28, 2026: The study expansion was formally announced.
The Big Picture
This study follows the established standard of care involving CDK4/6 inhibitor breast cancer treatment protocols. It represents a potential strategy to extend the efficacy of these standard therapies in patients who have developed treatment resistance.
This research could eventually offer new treatment pathways for patients currently facing resistance to standard hormone-blocking therapies. As the trial progresses toward potential expansion into the United States, further data on safety and tolerability will determine future access.
The takeaway
Clinical studies focusing on treatment-resistant cancers are essential for evolving standard therapy protocols beyond existing limitations. Patients and healthcare providers should monitor trial progress as investigators continue to analyze blood and tissue samples for signs of efficacy.
Further reading
For additional context on oncology breakthroughs, visit the Cancer section.
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