# 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

Source: https://onco.cc/trials/nct07100106/  
OnCo record `nct07100106` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial of Giredestrant and Abemaciclib in HR-positive / HER2-negative breast cancer, run by Genentech, Inc., now recruiting.

## Summary

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 is a phase 1/2 interventional study registered as NCT07100106 by Genentech, Inc., with 285 participants planned, started 2025-10-07 and due to reach its primary completion in 2028-08-31. Interventions recorded: GDC-4198, Giredestrant and Abemaciclib.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT07100106
- Phase: 1/2
- Setting: 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
- Sponsor: Genentech, Inc.
- Enrolled: 285

## Sources

- ClinicalTrials.gov NCT07100106: https://clinicaltrials.gov/study/NCT07100106

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- drugs: [Abemaciclib](https://onco.cc/drugs/abemaciclib/), [Giredestrant](https://onco.cc/drugs/giredestrant/)
- companies: [Flatiron Health (Roche)](https://onco.cc/companies/flatiron-health/)

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