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

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.

Trial Details

NCT ID
NCT07214662
Phase
PHASE1
Sponsor
Genentech, Inc.
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • GDC-0587
  • Giredestrant
  • Omeprazole
Locations (sample)
  • Grand Rapids, Michigan, United States|42.96336,-85.66809
  • San Antonio, Texas, United States|29.42412,-98.49363
  • Tainan, Taiwan|22.99083,120.21333

Key Eligibility Criteria

  • Agreement to adhere to the contraception requirements
  • For females of childbearing potential ≤60 years of age and males: treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy begin…
  • Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic
  • Previously documented ER+ and HER2- tumor according to American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) or Euro…

For full eligibility, visit ClinicalTrials.gov.

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