Trial Expanded for New Breast Cancer Treatment Approach
Researchers are testing if an experimental drug can help patients who have stopped responding to standard therapies.
Updated on Sept. 28, 2026 in Cancer
Live Poll
Would you participate in an early-stage clinical trial for a treatment-resistant cancer diagnosis?
Kazia Therapeutics has expanded a clinical trial testing the drug paxalisib in patients with HR-positive, HER2-negative breast cancer. The study aims to determine if this approach can overcome resistance to existing treatment options.
Why it matters
Many patients with advanced breast cancer eventually develop resistance to standard CDK4/6 inhibitor treatments, leaving them with few effective alternatives. This study investigates whether adding paxalisib can resensitize tumors, potentially offering a new path to extend treatment efficacy.
This clinical trial is evaluating the safety and tolerability of paxalisib when combined with fulvestrant and palbociclib in humans. Preliminary evidence suggesting the drug may resensitize treatment-resistant tumors was limited to cell cultures, blood samples, and animal studies.
The players
Kazia Therapeutics
A biotechnology company focused on developing new oncology treatments, including investigational therapies for brain and breast cancer.
The details
Paxalisib is being studied in combination with the hormone therapy fulvestrant and the CDK4/6 inhibitor palbociclib. The trial evaluates two different dosages to determine how effectively they work together to inhibit tumor growth. Researchers are also analyzing blood and tissue samples from participants to identify specific mutations or biomarkers that might indicate a patient's likelihood of responding to this regimen.
Timeline
September 28, 2026
Health Landscape
This study addresses the common challenge of resistance that occurs during standard CDK4/6 inhibitor therapy regimens. It represents an evolving effort to improve outcomes by layering new agents onto existing standard-of-care treatments.
This study is currently limited to participants enrolled in Australia, with future expansion planned for the United States. If you are managing HR-positive, HER2-negative breast cancer, discuss the potential of combination clinical trials with your oncologist to see if such options are suitable.
The takeaway
This trial investigates a potential new way to restore sensitivity to common breast cancer treatments. Patients interested in emerging options should track study progress and discuss clinical trial availability with their specialized care team.
Further reading
Learn more about the latest research developments in our Cancer section.
Live Poll
Would you participate in an early-stage clinical trial for a treatment-resistant cancer diagnosis?
