OncoMatch/Clinical Trials/NCT07214662
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer
Is NCT07214662 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including GDC-0587 and Giredestrant for breast cancer.
Treatment: GDC-0587 · Giredestrant · Omeprazole — This is a first-in-human, Phase Ia/Ib, dose-escalation and expansion study evaluating the safety, pharmacokinetics, and activity of GDC-0587 (cyclin-dependent kinase-4 \[CDK4\] inhibitor) as a monotherapy and in combination with giredestrant in participants with locally advanced or metastatic estrogen receptor-positive and human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer who have previously progressed during or after CDK 4/6 inhibitor therapy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Endocrine / hormonal
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative (negative)
Required: ESR1 positive (positive)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: CDK4/6 inhibitor — locally advanced or metastatic
Disease progression during or following treatment with an approved CDK 4/6 inhibitor, with or without endocrine therapy, in the locally advanced or metastatic setting
Cannot have received: anti-cancer therapies (including investigational therapies)
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
Treatment with an approved oral endocrine therapy within 7 days prior to initiation of study drug
Cannot have received: fulvestrant (fulvestrant)
treatment with fulvestrant ... within 21 days prior to initiation of study drug
Cannot have received: CDK inhibitor
treatment with ... an approved/investigational CDK inhibitor within 21 days prior to initiation of study drug
Lab requirements
Kidney function
creatinine clearance ≥60 ml/min (calculated through use of the cockcroft-gault formula)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- START - Midwest - EDOS · Grand Rapids, Michigan
- START - San Antonio - EDOS · San Antonio, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07214662 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-cancer therapies (including investigational therapies), oral endocrine therapy, fulvestrant disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 positive 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