Actively 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
Led by Genentech, Inc. · Updated on 2026-05-04
136
Participants Needed
4
Research Sites
228 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agree to follow contraception requirements
- Females of childbearing potential � 60 years and males must receive luteinizing hormone-releasing hormone (LHRH) agonist therapy starting at least 2 weeks before treatment and continue during the study
- Confirmed adenocarcinoma of the breast that is locally advanced or metastatic
- Previously documented ER+ and HER2- tumor as per ASCO/CAP, ESMO, or similar guidelines
- Disease progressed during or after treatment with an approved CDK 4/6 inhibitor
- Measurable or evaluable disease per RECIST v1.1
- ECOG Performance Status of 0 or 1
- Life expectancy of at least 6 months
- Creatinine clearance � 60 mL/min (Cockcroft-Gault formula)
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study
- Advanced, symptomatic visceral spread requiring cytotoxic chemotherapy at study entry
- Five or more prior systemic therapy lines in locally advanced or metastatic setting
- Received anti-cancer therapies within 28 days or 5 drug half-lives before study drug
- Received approved oral endocrine therapy within 7 days or fulvestrant/CDK inhibitor within 21 days before study drug
- History of Grade adverse event from prior CDK inhibitor leading to permanent discontinuation
- Poor peripheral venous access
- Malabsorption or gastrointestinal conditions/surgeries affecting drug absorption
- Major surgery within 28 days before study drug
- Untreated, active central nervous system metastases
- Current or recent infection requiring systemic antibiotics or chronic infection treated within 1 year
- History of malignancy within 3 years except current study cancer
- Clinically significant abnormal ECG history
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
START - Midwest - EDOS
Grand Rapids, Michigan, United States, 49546-7062
Actively Recruiting
2
START - San Antonio - EDOS
San Antonio, Texas, United States, 78229-3307
Actively Recruiting
3
National Taiwan University Hospital
Taipei, Taipei City, Taiwan, 10002
Actively Recruiting
4
National Cheng Kung University Hospital
Tainan, Taiwan, 70403
Actively Recruiting
Research Team
R
Reference Study ID Number: GO46057 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here