A Phase 3 Open-label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant HR+ HER2- Locally Advanced or Metastatic Breast Cancer

Brief description of study

This is a Phase 3 study testing whether the study medicine RLY-2608 (selective inhibitors of PI3Ka) along with fulvestrant (standard hormone therapy) is more effective and safer than other medicines, such as capivasertib (AKT inhibitor) and fulvestrant combination for patients with HR+/HER2- advanced breast cancer, whose cancer has come back after prior treatment with a CDK4/6 inhibitor and shows changes in the PIK3CA gene.

Patients will be randomly divided into two groups. Group 1 will receive the RLY-2608 and fulvestrant, and Group 2 will receive capivasertib and fulvestrant. The study team will monitor all patients for the time interval it takes for the cancer to come back or worsen (PFS) for both groups, as well as the overall survival of patients. Blood samples will be collected from all patients to see how their bodies are handling the study medicine and to check their overall well-being. Specialized testing known as ctDNA testing will be done for all patients to learn about their cancer. All patients will undergo special scans to check how their tumors are responding to the medication. All patients will be closely monitored for potential side effects and safety concerns.


Clinical Study Identifier: s25-00226
ClinicalTrials.gov Identifier: NCT06982521
Principal Investigator: Nancy Chan.
Other Investigators: Caitlin Elizabeth Ordonez Ferri, Ariel Karwat, Shridar Ganesan, Elizabeth Comen, Yan Fon Mei, Danielle Seidman, Natalie Jill Klar, Yelena Novik, Marleen I Meyers, Neil Vasan, Elena Katz, Yael Simons, Zhanna Logman, Helen Pass, Maryann J Kwa, Nina D'Abreo, Stephanie M Erichsen, Alana Grace Spadalik, Samantha Lynn Heller, Amanda Marie Buzolich, Anastasiya Apanasyuk, Ruth Oratz, Amy N. Solan, Naomi Yu Ko, Mary L. Gemignani, Naamit K. Gerber, Wanqing Iris Zhi, Soojin Ahn, Jonathan Haas, Thomas B. Daniels, Phyu Phyu Soe, Douglas K Marks, Alexander A Hindenburg.


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