OncoMatch/Clinical Trials/NCT07100106
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 NCT07100106 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including GDC-4198 and Giredestrant for breast cancer.
Treatment: GDC-4198 · Giredestrant · Abemaciclib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Endocrine / hormonal
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (positive)
Previously documented ER+ and HER2- tumor according to ASCO/CAP or ESMO guidelines
Required: HER2 (ERBB2) wild-type (absence)
Previously documented ER+ and HER2- tumor according to ASCO/CAP or ESMO guidelines
Performance status
ECOG 0–1(Restricted strenuous activity)
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Prior therapy
Must have received: CDK4/6 inhibitor — locally advanced or metastatic
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
Must have received: endocrine therapy — locally advanced or metastatic
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
Cannot have received: chemotherapy for metastatic breast cancer
Have received prior chemotherapy for metastatic breast cancer
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope · Duarte, California
- UC San Diego Moores Cancer Center · La Jolla, California
- Winship Cancer Institute of Emory University · Atlanta, Georgia
- City of Hope® Cancer Center Chicago · Zion, Illinois
- Washington University Siteman Cancer Center · St Louis, Missouri
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07100106 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy for metastatic breast cancer disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages