A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and i… (NCT07214662) | Clinical Trial Compass
RecruitingPhase 1
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
United States, Taiwan136 participantsStarted 2026-01-13
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 beginning at least 2 weeks prior to Cycle 1, Day 1 and agreement to continue LHRH agonist therapy for the duration of the study
* 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 European Society of Medical Oncology (ESMO) guidelines or any national guidelines with criteria conforming to ASCO/CAP or ESMO guidelines
* 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
* Measurable, or non-measurable but evaluable, disease per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy ≥6 months
* Creatinine clearance ≥60 milliliter per minute (mL/min) (calculated through use of the Cockcroft-Gault formula)
Exclusion Criteria:
* Pregnant or breastfeeding, or intention of becoming pregnant during the study
* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial primarily designed to test safety and find the right dose of GDC-0587, rather than to prove it works, what does that mean for my personal risk compared to staying on a more established treatment for ER+/HER2- breast cancer?
2The trial is measuring dose-limiting toxicities — meaning some doses may cause serious side effects — so what kinds of side effects have been seen with drugs that work similarly to GDC-0587, and how would those be managed if they happened to me?
3This study tests GDC-0587 both alone and combined with giredestrant, so would my doctor have any say in which approach I'd be assigned to, and how would that decision be made?
4Given that this is an early-phase trial still recruiting, are there any standard or approved treatments for locally advanced or metastatic ER+/HER2- breast cancer that I should consider trying first before looking at an experimental option like this?
5Because Phase 1 trials often involve frequent clinic visits for monitoring, blood draws, and dose adjustments, what would the realistic time commitment and travel burden look like for me if I were to discuss enrolling in this study with my care team?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants with Adverse Events
Timeframe: From Baseline to 30 days after final dose of study treatment (Up to approximately to 18 months)
2
Percentage of Participants with Dose-limiting Toxicity (DLTs)
Timeframe: Phase 1a: Days 1-28 of Cycle 1; Phase 1b: Days 1-28 of Cycle 1 (Each cycle is 28 days)
Trial details
NCT IDNCT07214662
SponsorGenentech, Inc.
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2030-06-01
Contact for this trial
Reference Study ID Number: GO46057 https://forpatients.roche.com/