Viktoria-1 Reveals Promising New Treatment for Metastatic Breast Cancer
The latest findings demonstrated that gedatolisib, when combined with fulvestrant (Faslodex), with or without palbociclib (Ibrance), nearly doubled progression-free survival compared with the current standard treatment of fulvestrant and alpelisib (Piqray) in patients with a PIK3CA mutation. Progression-free survival refers to the length of time a person lives without their cancer growing or spreading. In the VIKTORIA-1 study, patients receiving gedatolisib experienced a median progression-free survival of approximately 11 months, compared with 5.6 months for those receiving fulvestrant and alpelisib.
Who Could Benefit?
The trial focused on people with HR-positive, HER2-negative metastatic breast cancer whose disease had progressed despite treatment with both:
- a CDK4/6 inhibitor (such as palbociclib), and
- an aromatase inhibitor, a commonly prescribed hormone therapy.
Importantly, earlier results from the VIKTORIA-1 trial also demonstrated improved outcomes for patients without a PIK3CA mutation, suggesting gedatolisib may have the potential to benefit a broader group of people living with metastatic breast cancer.
What Does This Mean for Patients?
While metastatic breast cancer remains incurable, advances in targeted therapies continue to improve treatment options by delaying disease progression and helping people maintain their quality of life for longer. Gedatolisib works by blocking two important signalling pathways involved in cancer cell growth—the PI3K and mTOR pathways—which are frequently overactive in hormone receptor-positive breast cancers. By targeting these pathways simultaneously, researchers hope to overcome treatment resistance that can develop with existing therapies.
The U.S. Food and Drug Administration (FDA) is expected to review gedatolisib for approval during 2026, bringing it one step closer to becoming an additional treatment option for eligible patients worldwide.
BCRC-WA’s Commitment to Research
Breast Cancer Research Centre WA is proud to contribute to international clinical trials that help shape the future of breast cancer treatment. Through our Clinical Trials Unit, eligible Western Australian patients have access to innovative therapies years before they become widely available. Every clinical trial brings us closer to more personalised, effective treatments and ultimately, better outcomes for people affected by breast cancer.
