A PHASE Ib/II OPEN-LABEL MULTICENTER RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE TREATMENT COMBINATIONS IN PATIENTS WITH METASTATIC BREAST CANCER (MORPHEUS-panBC)

Brief description of study

This is a Phase 1b/2 clinical study for people with metastatic (which is breast cancer that has spread to other parts of the body) or locally advanced breast cancer that cannot be removed by surgery. The study is testing several new treatment combinations to see how well they work, how safe they are, and how the body processes them. The study includes different types of breast cancer, including triple-negative breast cancer (TNBC), hormone receptor-positive (HR+), HER2-negative breast cancer, and HER2-positive or HER2-low breast cancer. Even though treatments are available for these cancers, many patients eventually stop responding to them and their cancer continues to grow. Researchers are looking for better treatment options to help patients live longer and improve disease control.

The study is divided into six groups (cohorts) based on the type of breast cancer a patient has and any previous treatments they have received. Cohort 1 includes patients with PD-L1-positive TNBC who have not yet received treatment for metastatic disease. Cohort 2 includes patients with TNBC whose cancer worsened after their first treatment for advanced disease. Cohort 3 includes patients with HR-positive, HER2-negative breast cancer that has a PIK3CA gene mutation. Cohort 4 includes patients with HER2-positive or HER2-low breast cancer with a PIK3CA mutation whose cancer has worsened after standard treatments. Cohort 5 includes patients with HR-positive, HER2-negative breast cancer, a PIK3CA mutation, and pre-diabetes. Cohort 6 includes patients with HR-positive, HER2-negative breast cancer and a PIK3CA mutation who are receiving a CDK4 inhibitor, a type of targeted cancer treatment. By studying these groups at the same time, researchers hope to learn which treatment combinations work best for different types of advanced breast cancer and which patients may benefit the most.

Please note the only Cohort being opened at our site will be Cohort 5.


Clinical Study Identifier: s25-01689
ClinicalTrials.gov Identifier: NCT03424005
Principal Investigator: Maryann J Kwa.
Other Investigators: Caitlin Elizabeth Ordonez Ferri, Anam Qureshi, Shridar Ganesan, Elizabeth Comen, Danielle Seidman, Natalie Jill Klar, Annmarie Johnson-Rowe, Yelena Novik, Laura Palazzolo, Marleen I Meyers, Neil Vasan, Jonathan B Kahn, Akilah Monique Bryant, Carol M Lee, Amanda Marie Buzolich, Anastasiya Apanasyuk, Ruth Oratz, Stacy Antwi, Naomi Yu Ko, Wanqing Iris Zhi, Amy M Ciriaco, Nancy Chan, Phyu Phyu Soe, Alexander A Hindenburg, Douglas K Marks.


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