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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
285
GDC-4198 will be administered orally.
Giredestrant will be administered orally.
Abemaciclib will be administered orally.
City of Hope
Duarte, California, United States
RECRUITINGCity of Hope - Orange County Lennar Foundation Cancer Center
Irvine, California, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGWinship Cancer Institute of Emory University
Atlanta, Georgia, United States
RECRUITINGCity of Hope® Cancer Center Chicago
Zion, Illinois, United States
RECRUITINGBarbara Ann Karmanos Cancer Institute
Detroit, Maine, United States
RECRUITINGWashington University Siteman Cancer Center
St Louis, Missouri, United States
RECRUITINGRutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
RECRUITINGNew York Cancer & Blood Specialists
East Patchogue, New York, United States
RECRUITINGUPMC - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
RECRUITING...and 6 more locations
Phase Ib: Incidence and Severity of Adverse Events (AEs)
Severity of AEs determined according to the CTCAE v5.0 grading scale
Time frame: Up to 36 months
Phase Ib: Number of Participants With Dose-Limiting Toxicity (DLTs)
Time frame: From Day 1 to Day 28 of Cycle 1 (1 cycle=28 days)
Phase II: Progression-free Survival (PFS)
Time frame: Up to 36 months
Phase Ib: Objective Response Rate (ORR)
Time frame: Up to 36 months
Phase Ib: Clinical Benefit Rate (CBR)
Time frame: Up to 36 months
Phase Ib: Area Under the Concentration Time-Curve From Time 0 to Last Measurable Concentration (AUC0-t) of GDC-4198
Time frame: Up to 36 months
Phase Ib: Area Under the Concentration Time-Curve From Time 0 to Infinity (AUCinf) of GDC-4198
Time frame: Up to 36 months
Phase Ib: Maximum Serum Concentration (Cmax) of GDC-4198
Time frame: Up to 36 months
Phase II: ORR
Time frame: Up to 36 months
Phase II: Duration of Response (DOR)
Time frame: Up to 36 months
Phase II: CBR
Time frame: Up to 36 months
Phase II: Overall Survival (OS)
Time frame: Up to 36 months
Phase II: OS Rate at 6 Months and 12 Months
Time frame: Month 6, Month 12
Phase II: PFS Rate at 6 Months and 12 Months
Time frame: Month 6, Month 12
Phase II: Incidence and Severity of Adverse Events (AEs)
Severity of AEs determined according to the CTCAE v5.0 grading scale
Time frame: Up to 36 months
Phase II: Plasma Concentration of GDC-4198
Time frame: Up to 36 months
Reference Study ID Number: GO46021 https://forpatients.roche.com/
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