MoonROSE
Research type
Research Study
Full title
A PHASE Ib/II MULTICENTER, OPEN-LABEL, RANDOMIZED STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF GDC-4198 ALONE AND IN COMBINATION WITH GIREDESTRANT IN COMPARISON WITH ABEMACICLIB AND GIREDESTRANT IN PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE BREAST CANCER WHO HAVE PREVIOUSLY PROGRESSED DURING OR AFTER A CDK4/6 INHIBITOR
IRAS ID
1012912
Contact name
Head of EU Trial Information Support Line-TISL, Switzerland
Contact email
Sponsor organisation
Genentech, Inc.
Eudract number
2025-521128-31
Clinicaltrials.gov Identifier
Research summary
Breast cancer is the most frequent cancer diagnosed in women. As per WHO, around 2.3 million new cases were reported in 2022 globally. Oestrogen receptor positive (ER+) refers to a type of breast cancer where high levels of oestrogen (a hormone) in the cancer cells promote growth and spread of cancer.
This study is being conducted to evaluate the safety and activity of study drug, GDC‑4198 alone or in combination with another experimental drug called giredestrant in participants with ER+ breast cancer. GDC-4198 blocks proteins (CDK2, CDK4 and CDK6) that help breast cancer cells grow and multiply. Cyclin-dependent kinases (CDKs) are enzymes that regulate the cell cycle. Based on the data, it is assumed that GDC-4198 and giredestrant will effectively target cell division, multiplication and oestrogen-driven spread. The combination therapy also offers a treatment that may provide an improved and more durable clinical benefit for patients. Abemaciclib is an approved CDK4/6 inhibitor used for the treatment of breast cancer.
All participants aged 18 years and above at time of signing Informed Consent Form are eligible to participate in the study. The study is being conducted at 4 NHS sites in the UK. Approximately 15 participants will take part in the study in the UK and 285 worldwide.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
25/NE/0231
Date of REC Opinion
26 Mar 2026
REC opinion
Further Information Unfavourable Opinion