Morpheus: This Phase I/II trial is evaluating how safe and tolerable a targeted cancer drug (Giredestrant) is alone, or combined with various other cancer drugs, in people with ER-positive breast cancerA Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS- BREAST CANCER)

Summary

This is an open-label, randomised umbrella study for people with inoperable, locally advanced or metastatic, ER-positive breast cancer. It has one Active Comparator Arm and five Experimental Arms. In the Active Comparator Arm, participants will receive Giredestrant monotherapy, administered as 30mg orally, once per day in a 28-day cycle. In Experimental Arm 1, participants will receive Giredestrant (30mg orally, once per day in a 28-day cycle) in combination with Abemaciclib (150mg orally, twice daily in a 28-day cycle). In Experimental Arm 2, participants will receive Giredestrant (30mg orally, once per day in a 28-day cycle) in combination with Ipatasertib (400mg orally, once per day on Days 1-21 of a 28-day cycle). In Experimental Arm 3, participants will receive Giredestrant (30mg orally, once per day in a 28-day cycle) in combination with Inavolisib (9mg orally, once per day in a 28-day cycle). In Experimental Arm 4, participants will receive Giredestrant (30mg orally, once per day in a 28-day cycle) in combination with Ribociclib (600mg orally, once per day on Days 1-21 of a 28-day cycle). Finally, participants in Experimental Arm 5 will receive Giredestrant (30mg orally, once per day in a 28-day cycle) in combination with Everolimus (10mg orally, once per day in a 28-day cycle). All treatments will be taken until unacceptable toxicity or disease progression.