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Study identifier: NCT07214662 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Breast Cancer  ·  Sponsor: Genentech, Inc.

PhasePhase 1
Planned participants136
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Reference Study ID Number: GO46057 https://forpatients.roche.com/ No attachments to email below.  ·  888-662-6728 (U.S. only)  ·  global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Always discuss trial participation with your own doctor first.

Locations (4)

START - Midwest - EDOSGrand Rapids, Michigan, United StatesRecruiting
START - San Antonio - EDOSSan Antonio, Texas, United StatesRecruiting
National Taiwan University HospitalTaipei, Taipei City, TaiwanRecruiting
National Cheng Kung University HospitalTainan, TaiwanRecruiting

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Source record: clinicaltrials.gov/study/NCT07214662