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NCT07100106 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Breast Cancer, sponsored by Genentech.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 285
- Enrollment target
- 20
- Study locations
NCT07100106: Recruiting Phase 1 study of Breast Cancer, sponsored by Genentech.
NCT07100106 is a Phase 1 study of Breast Cancer that is actively recruiting participants, run by Genentech. The registered enrollment target is 285 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07100106, a Phase 1 study of Breast Cancer, is actively recruiting participants, sponsored by Genentech.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 285 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Severity of AEs determined according to the CTCAE v5.0 grading scale
Conditions Studied
Interventions
- DRUG Abemaciclib
- DRUG Giredestrant
- DRUG GDC-4198
Study Locations (20)
Other
- Centre Francois Baclesse - Caen
- Centre Eugene Marquis - Rennes
- Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON - Barcelona
- Hospital Beata Maria Ana - Madrid
- Hospital Universitario 12 de Octubre - Madrid
California
- City of Hope - Duarte
- City of Hope - Orange County Lennar Foundation Cancer Center - Irvine
Florida
- Moffitt Cancer Center - Tampa
Georgia
- Winship Cancer Institute of Emory University - Atlanta
Illinois
- City of Hope® Cancer Center Chicago - Zion
Maine
- Barbara Ann Karmanos Cancer Institute - Detroit
Missouri
- Washington University Siteman Cancer Center - St Louis
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 285 participants |
| Start Date | 2025-10-07 |
| Est. Completion | 2028-08-31 |
| Phase | Phase 1 |
What NCT07100106 shows while recruiting
NCT07100106 is an interventional study that assigns participants to a tested intervention. The registered 285 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Abemaciclib is the first listed.
NCT07100106 names 20 study sites across 15 states, led by Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT07100106 about?
NCT07100106 is a clinical study titled "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". 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: Ph...
What is the current status of trial NCT07100106?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 285 participants. The study started on 2025-10-07. Estimated completion is 2028-08-31.
What conditions does trial NCT07100106 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT07100106?
The interventions under investigation include: Abemaciclib (DRUG), Giredestrant (DRUG), GDC-4198 (DRUG).
Who is sponsoring clinical trial NCT07100106?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07100106 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Maine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07100106's enrollment target sits among peer trials
285 292nd of 1224 higher than 931 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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