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Priya Life Science Compound trial record
Compound · clinical trials

Giredestrant clinical trials

Also listed in trial records as GDC-9545, RO7197597, RG6171
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 17 trials in our USA, South Korea, Spain, Germany, UK, Australia, France, Italy, Canada, Taiwan, China, Turkey, Brazil, Israel, Poland, Belgium, Mexico, Portugal, Japan, India, Austria, Singapore, Switzerland, Czechia, Egypt, Ireland, Netherlands, Sweden and Denmark registers that name Giredestrant as an intervention. Synced 10 Nov 2026
17Current trials
8Recruiting now
4Lead sponsors
29Country registers
At a glance

Giredestrant is named as an intervention in 17 current clinical trials in our USA, South Korea, Spain, Germany, UK, Australia, France, Italy, Canada, Taiwan, China, Turkey, Brazil, Israel, Poland, Belgium, Mexico, Portugal, Japan, India, Austria, Singapore, Switzerland, Czechia, Egypt, Ireland, Netherlands, Sweden and Denmark registers. 8 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Hoffmann-La Roche (11). The most-studied condition is Breast Cancer.

How Giredestrant works

All drug targets →
  • Estrogen receptor alpha degrader Degrader
    Target: ESR1 estrogen receptor 1
    ✓ In ChEMBL and the Guide to Pharmacology
Diseases it has been tested for in clinical trials, by furthest phase
  • Breast cancerPhase 3
  • Endometrial cancerPhase 2
  • Estrogen-receptor positive breast cancerPhase 2
  • Fallopian tube neoplasmPhase 2
  • Ovarian epithelial tumorPhase 2

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4650316, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 12715, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Giredestrant

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Trials by status

  • Recruiting847%
  • Active, closed953%

Trials by phase

  • Phase 3847%
  • Phase 2529%
  • Phase 1/2318%
  • Phase 116%
01

Clinical trials of Giredestrant

17 trials
StudyPhaseStatusLead sponsorRegisters
A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study
NCT05862285 · Cancer
Phase 3 Recruiting Hoffmann-La Roche UK, China, France, Belgium, Poland, Canada, Mexico, Japan, South Korea, Taiwan
A Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes of Giredestrant in Participants With ER+/HER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy (novERA Breast Cancer)
NCT07541079 · Early Breast Cancer
Phase 3 Recruiting Genentech, Inc USA
A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment
NCT07827573 · ClinicalTrials.gov ↗ · Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer
Phase 3 Recruiting Hoffmann-La Roche Canada
NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative Early Breast Cancer
NCT06259929 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 2 Recruiting Fondazione Oncotech Italy
A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
NCT07054190 · Breast Cancer
Phase 2 Recruiting Hoffmann-La Roche USA, Germany, Spain, Canada, Brazil, South Korea
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
NCT03424005 · Metastatic Breast Cancer
Phase 1/2 Recruiting Hoffmann-La Roche UK, USA, Germany, France, Spain, South Korea, Taiwan, Australia, Israel
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
NCT04802759 · Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer
Phase 1/2 Recruiting Hoffmann-La Roche USA, Spain, South Korea, Australia, Israel
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
NCT07100106 · Breast Cancer
Phase 1/2 Recruiting Genentech, Inc USA, China, Germany, France, Spain, Italy, Canada, Brazil, South Korea, Australia
A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)
NCT04546009 · Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
Phase 3 Active, closed Hoffmann-La Roche UK, USA, China, Germany, France, Spain, Italy, Belgium, Denmark, Poland, Austria, Portugal, Turkey, Canada, Brazil, Mexico, Japan, South Korea, Taiwan, Australia, Israel
A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)
NCT04961996 · Early Breast Cancer
Phase 3 Active, closed Hoffmann-La Roche Ireland, UK, USA, India, China, Germany, France, Spain, Italy, Netherlands, Belgium, Sweden, Poland, Switzerland, Austria, Czechia, Portugal, Turkey, Canada, Brazil, Mexico, Japan, South Korea, Taiwan, Australia, Israel, Egypt
A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)
NCT05296798 · Locally Advanced or Metastatic Breast Cancer
Phase 3 Active, closed Hoffmann-La Roche UK, USA, India, China, Germany, France, Spain, Italy, Belgium, Poland, Portugal, Turkey, Brazil, Mexico, South Korea, Taiwan, Egypt
A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)
NCT05306340 · Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer
Phase 3 Active, closed Genentech, Inc UK, USA, Germany, Spain, Italy, Turkey, Japan, South Korea, Taiwan, Singapore
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
NCT06065748 · Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
Phase 3 Active, closed Hoffmann-La Roche USA, India, China, Germany, France, Spain, Italy, Belgium, Poland, Austria, Portugal, Turkey, Canada, Brazil, Mexico, South Korea, Taiwan, Singapore, Australia, Israel
A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)
NCT04576455 · Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
Phase 2 Active, closed Hoffmann-La Roche UK, USA, China, Germany, Poland, Turkey, Brazil, South Korea, Taiwan, Singapore, Australia, Israel
A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors
NCT04931342 · Ovarian Cancer
Phase 2 Active, closed Hoffmann-La Roche UK, USA, Germany, France, Spain, Italy, Switzerland, Czechia, Turkey, Canada, South Korea, Australia
A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population
NCT05708235 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 2 Active, closed MedSIR Spain
A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer
NCT03332797 · Breast Cancer
Phase 1 Active, closed Genentech, Inc UK, USA, Spain, South Korea, Australia, Israel

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Giredestrant

13 conditions
Breast Cancer5Early Breast Cancer3Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer1Locally Advanced or Metastatic Breast Cancer1Ovarian Cancer1Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer1Metastatic Breast Cancer1Cancer1Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer1Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer1Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer1Estrogen Receptor-Positive Breast Cancer1
All 13 conditions
Condition (as registered)Trials
Breast Cancer5
Early Breast Cancer3
Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer1
Locally Advanced or Metastatic Breast Cancer1
Ovarian Cancer1
Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer1
Metastatic Breast Cancer1
Cancer1
Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer1
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer1
Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer1
Estrogen Receptor-Positive Breast Cancer1
HER2-Negative Breast Cancer1
05

Related compounds

06

Questions about Giredestrant trials

How many clinical trials are testing Giredestrant?

17 current trials in our USA, South Korea, Spain, Germany, UK, Australia, France, Italy, Canada, Taiwan, China, Turkey, Brazil, Israel, Poland, Belgium, Mexico, Portugal, Japan, India, Austria, Singapore, Switzerland, Czechia, Egypt, Ireland, Netherlands, Sweden and Denmark registers name Giredestrant (also registered as GDC-9545) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.

Are Giredestrant trials recruiting patients?

Yes. 8 of the 17 trials are recruiting: 5 with sites in USA, 5 with sites in South Korea, 4 with sites in Spain, 3 with sites in Germany, 2 with sites in UK, 3 with sites in Australia, 3 with sites in France, 2 with sites in Italy, 4 with sites in Canada, 2 with sites in Taiwan, 2 with sites in China, 2 with sites in Brazil, 2 with sites in Israel, 1 with sites in Poland, 1 with sites in Belgium, 1 with sites in Mexico and 1 with sites in Japan. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Giredestrant clinical trials?

Hoffmann-La Roche (11), Genentech, Inc (4), MedSIR (1) and Fondazione Oncotech (1). The number in brackets is how many trials each organisation leads.

Are there Giredestrant clinical trials in Ireland?

Yes. 1 trial in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Giredestrant works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Giredestrant works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Giredestrant (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.