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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
MinorTrial sites expanded: 64 → 74 locationsEligibility criteria expanded, about 13 wordsShow 1 more changeShow less
Eligibility criteria expanded, about 13 words
MinorTrial sites expanded: 61 → 64 locationsv15
MinorTrial sites expanded: 52 → 61 locationsv14
MinorTrial sites expanded: 45 → 52 locationsv13
MinorTrial sites expanded: 39 → 45 locationsv12
MinorTrial sites expanded: 35 → 39 locationsv11
MinorTrial sites expanded: 21 → 35 locationsEligibility criteria shortened, about 19 words · Secondary endpoints: 13 to 11v10Show 2 more changesShow less
NotablePrimary and study completion dates: Jul 31, 2030 to Aug 31, 2028Study sites: 14 to 16v8Show 1 more changeShow less
Study sites: 14 to 16
MinorStudy sites: 9 to 14v7
MinorStudy sites: 6 to 9v6
MinorStudy sites: 5 to 6v5
MinorStudy sites: 1 to 5Start date changed from estimate of Sep 30, 2025 to Oct 7, 2025v4Show 1 more changeShow less
Start date changed from estimate of Sep 30, 2025 to Oct 7, 2025
NotableStart date: Aug 29, 2025 to Sep 30, 2025v3
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 0 to 1 · Start date: Aug 1, 2025 to Aug 29, 2025v2Show 2 more changesShow less
Study sites: 0 to 1
Start date: Aug 1, 2025 to Aug 29, 2025
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.