A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
NCT07100106
Phase
Phase 1/Phase 2
Recruitment status
Recruiting
Participants
Lead sponsor
Genentech, Inc.
Start date
2025-10-07
Number of sites
- Summary
- The purpose of this study is to assess the safety of GDC-4198 alone and in combination with giredestrant and also the efficacy of GDC-4198 + giredestrant versus abemaciclib + giredestrant in participants with locally advanced or metastatic ER+, HER2- breast cancer. The study consists of 2 phases: Phase Ib and Phase II. Phase Ib will evaluate the safety and pharmacokinetics (PK) of GDC-4198 alone and in combination with giredestrant. Phase II stage will compare the activity and safety of GDC-4198 and giredestrant with abemaciclib and giredestrant. Participants from Study RGT-419B\_01-101 (NCT05304962) who are experiencing clinical benefit with GDC-4198, as determined by the investigator, may enroll in this study and continue receiving GDC-4198 at their current dose level following closure of Study RGT-419B\_01-101.
- Acronym
- MoonROSE
- Short title
- A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
- Official 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1/Phase 2
- Study type
- Interventional
- Completion date
- 2028-08-31
- First posted
- 2025-08-03
- Registry last updated
- 2026-10-26
- Primary completion date
- 2028-08-31
- Start date
- 2025-10-07
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Genentech, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07100106
- ClinicalTrials.gov ID
- NCT07100106
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
Phase Ib: Incidence and Severity of Adverse Events (AEs)
Timeframe: Up to 36 months
Severity of AEs determined according to the CTCAE v5.0 grading scale
Phase Ib: Number of Participants With Dose-Limiting Toxicity (DLTs)
Timeframe: From Day 1 to Day 28 of Cycle 1 (1 cycle=28 days)
Phase II: Progression-free Survival (PFS)
Timeframe: Up to 36 months
Phase Ib: Objective Response Rate (ORR)
Timeframe: Up to 36 months
Phase Ib: Clinical Benefit Rate (CBR)
Timeframe: Up to 36 months
Phase II: ORR
Timeframe: Up to 36 months
Phase II: Duration of Response (DOR)
Timeframe: Up to 36 months
Phase II: CBR
Timeframe: Up to 36 months
Phase II: Overall Survival (OS)
Timeframe: Up to 36 months
Phase II: OS Rate at 6 Months and 12 Months
Timeframe: Month 6, Month 12
Phase II: PFS Rate at 6 Months and 12 Months
Timeframe: Month 6, Month 12
Phase II: Incidence and Severity of Adverse Events (AEs)
Timeframe: Up to 36 months
Severity of AEs determined according to the CTCAE v5.0 grading scale
Phase II: Plasma Concentration of GDC-4198
Timeframe: Up to 36 months
Phase II: Recommended Dose of GDC-4198
Timeframe: Up to 36 months
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- Histologically and/or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic.
- Previously documented ER+ and HER2- tumor according to American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) or European Society of Medical Oncology (ESMO) guidelines or any national guidelines with criteria conforming to ASCO/CAP or ESMO guidelines.
- Disease progression during or after treatment with an approved cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and approved endocrine therapy (ET) in the locally advanced or metastatic setting.
- Measurable or non-measurable evaluable, disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Life expectancy >= 6 months.
- Current participant enrolled in Study RGT-419B_01-101 who is experiencing clinical benefit from GDC-4198, as determined by the investigator, at the time of consent and enrollment in this study.
- Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines.
- Have received more than one-line of therapy for locally advanced or metastatic disease.
- Have received prior chemotherapy for metastatic breast cancer.
- Treatment with an approved oral ET within 7 days prior to initiation of study drug; treatment with fulvestrant or an approved CDK4/6 inhibitor within 21 days prior to initiation of study drug.
- Malabsorption condition or other gastrointestinal (GI) conditions/surgeries that the investigator assesses may significantly interfere with enteral absorption
- History of malignancy within 3 years prior to screening, except for cancer under investigation in this study and malignancies with a negligible risk of metastasis or death.
- Known allergy or hypersensitivity to any component of the study treatments.
Sources for eligibility
- Clearview Cancer Institute - HuntsvilleHuntsville, United StatesRecruiting
- University of Arizona Cancer CenterTucson, United StatesRecruiting
- City of HopeDuarte, United StatesRecruiting
- City of Hope - Orange County Lennar Foundation Cancer CenterIrvine, United StatesRecruiting
- UC San Diego Moores Cancer CenterLa Jolla, United StatesRecruiting
- University of California San Diego Medical CenterSan Diego, United StatesRecruiting
- UCSF Helen Diller Family CCCSan Francisco, United StatesRecruiting
- University of Colorado Cancer CenterAurora, United StatesRecruiting
- Sylvester Comprehensive Cancer CenterMiami, United StatesRecruiting
- Moffitt Cancer CenterTampa, United StatesRecruiting
- Winship Cancer Institute of Emory UniversityAtlanta, United StatesRecruiting
- City of Hope® Cancer Center ChicagoZion, United StatesRecruiting
- Barbara Ann Karmanos Cancer InstituteDetroit, United StatesRecruiting
- Maryland Oncology Hematology - AnnapolisAnnapolis, United StatesRecruiting
- Massachusetts General HospitalBoston, United StatesRecruiting
- Washington University Siteman Cancer CenterSt Louis, United StatesRecruiting
- Rutgers Cancer Institute of New JerseyNew Brunswick, United StatesRecruiting
- New York Cancer & Blood SpecialistsEast Patchogue, United StatesRecruiting
- Montefiore Einstein Cancer CenterThe Bronx, United StatesRecruiting
- Levine Cancer InstituteCharlotte, United StatesRecruiting
- Novant Health Cancer InstituteCharlotte, United StatesRecruiting
- Novant Health Oncology SpecialistsWinston-Salem, United StatesRecruiting
- Cleveland Clinic Mercy HospitalCanton, United StatesRecruiting
- Cleveland Clinic Taussig Cancer CenterCleveland, United StatesRecruiting
- Oncology Associates of Oregon, P.CEugene, United StatesRecruiting
And 52 more, listed on the interactive page.
Sources for sites
- Related resource (www.gene.com)
- 2025
- 2025-521128-31-00
Sources for references
Related records
Drugs (2)
Collaborators (1)
- Roche (China) Holding Ltd.
Lead sponsors (1)
Conditions (2)
- Breast cancer Primary condition
- Breast neoplasm