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 (May 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
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (ER+)
Previously documented ER+ ... tumor according to American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) or European Society of Medical Oncology (ESMO) guidelines
Required: HER2 (ERBB2) wild-type (HER2-)
Previously documented ... HER2- tumor according to American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) or European Society of Medical Oncology (ESMO) guidelines
Performance status
ECOG 0–1(Restricted strenuous activity)
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 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 endocrine therapy (ET) in the locally advanced or metastatic setting
Cannot have received: chemotherapy
Exception: adjuvant or neoadjuvant chemotherapy allowed
Have received prior chemotherapy for metastatic breast cancer
Cannot have received: any anti-cancer therapy (including investigational therapies)
Exception: within 28 days or 5 drug elimination half-lives, whichever is shorter, prior to initiation of study drug
Treatment with anti-cancer therapies, including investigational therapies, within 28 days or 5 drug elimination half-lives, whichever is shorter, prior to initiation of study drug
Cannot have received: oral endocrine therapy
Exception: within 7 days prior to initiation of study drug
Treatment with an approved oral endocrine therapy (ET) within 7 days prior to initiation of study drug
Cannot have received: fulvestrant (fulvestrant)
Exception: within 21 days prior to initiation of study drug
treatment with fulvestrant ... within 21 days prior to initiation of study drug
Cannot have received: CDK4/6 inhibitor
Exception: within 21 days prior to initiation of study drug
treatment with ... an approved CDK4/6 inhibitor within 21 days prior to initiation of study drug
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope · Duarte, California
- City of Hope - Orange County Lennar Foundation Cancer Center · Irvine, California
- Moffitt Cancer Center · Tampa, Florida
- Winship Cancer Institute of Emory University · Atlanta, Georgia
- City of Hope® Cancer Center Chicago · Zion, Illinois
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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