9 active not recruiting, 9 recruiting, 7 completed, 2 not yet recruiting. 14 Phase 2, 11 Phase 1, 8 Phase 3.
By phase and status
Follow giredestrant: new trials by email Literature Review of giredestrant trials Research Report on giredestrant
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix .
Trial Phase Status Sponsor Enrollment Start Updated
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer GDC-4198, Fulvestrant, Letrozole - Advanced or Metastatic Breast Cancer Phase 1 Not yet recruiting 165 2026-12-15 2026-10-09 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 Giredestrant - Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer Phase 3 Recruiting 1500 2026-12-11 2026-11-03 A Study of a Medicine Called Atirmociclib in Combination With Giredestrant in Adult Participants With ER-positive, HER2-negative Early-stage Breast Cancer Atirmociclib, giredestrant, Atirmociclib placebo - Early Breast Cancer, Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Phase 3 Not yet recruiting 3800 2026-12-01 2026-10-22 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) Giredestrant - Early Breast Cancer Phase 3 Recruiting 300 2026-08-25 2026-10-20 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 GDC-0587, Giredestrant, Omeprazole - Breast Cancer Phase 1 Terminated 3 2026-01-13 2026-08-21 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 GDC-4198, Giredestrant, Abemaciclib - Breast Cancer Phase 1 / Phase 2 Recruiting 285 2025-10-07 2026-10-26 A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer Inavolisib, Ribociclib, Letrozole - Breast Cancer Phase 2 Recruiting 120 2025-09-09 2026-10-26 NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative Early Breast Cancer Abemaciclib 150 MG + Giredestrant 30 MG - Breast Cancer Phase 2 Recruiting 51 2025-01-27 2025-02-18 A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population Giredestrant, Abemaciclib, Inavolisib - Breast Cancer Phase 2 Active not recruiting 976 2024-04-01 2026-09-24 A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer Giredestrant, Triptorelin, Anastrozole - Breast Cancer Phase 2 Completed 231 2024-01-23 2026-02-24 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) Giredestrant, Fulvestrant, Abemaciclib - Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Phase 3 Active not recruiting 1050 2023-12-11 2026-09-14 Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10% Giredestrant, Tamoxifen - Breast Cancer, Breast Cancer, Early-Onset Phase 2 Completed 92 2023-07-20 2026-03-19 A Study of Giredestrant in Participants With Grade 1 Endometrial Cancer Giredestrant - Endometrial Cancer Phase 2 Completed 33 2023-06-27 2026-09-14 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) Giredestrant, Exemestane, Fulvestrant - Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer Phase 3 Active not recruiting 373 2022-08-03 2026-11-03 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) Phesgo, Giredestrant, Docetaxel - Locally Advanced or Metastatic Breast Cancer Phase 3 Active not recruiting 922 2022-07-18 2026-10-02 A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer Atezolizumab - 28 Day Cycle, Bevacizumab, Ipatasertib - Endometrial Cancer Phase 1 / Phase 2 Recruiting 148 2021-10-20 2026-04-01 A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors Ipatasertib, Cobimetinib, Trastuzumab Emtansine - Ovarian Cancer Phase 2 Active not recruiting 176 2021-10-07 2026-09-10 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) Giredestrant, Physician's Choice of Endocrine Therapy, LHRH Agonist - Early Breast Cancer Phase 3 Active not recruiting 4170 2021-08-27 2026-10-15 A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer Giredestrant, Abemaciclib, Ipatasertib - Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer Phase 1 / Phase 2 Recruiting 316 2021-06-22 2026-11-03 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-9545 Following a Single Oral Dose (Part 1) and to Evaluate the Absolute and Relative Bioavailability of Oral Capsule Formulations of GDC-9545 (Part 2) in Healthy Female Subjects of Non-Childbearing Potential [14C]-GDC-9545, GDC-9545 Solution for Infusion, GDC-9545/F12 Capsule - Healthy Volunteers Phase 1 Completed 16 2021-01-07 2023-02-02
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Conditions studied Breast Neoplasms (22) · Endometrial Neoplasms (2) · Carcinoma, Non-Small-Cell Lung (1) · Colorectal Neoplasms (1) · Liposarcoma (1) · Neoplasm Metastasis (1) · Neoplasm, Residual (1) · Ovarian Neoplasms (1) · Prostatic Neoplasms (1)
Sponsors Hoffmann-La Roche (12) · Genentech, Inc. (10) · MedSIR (2) · Pfizer (2) · Alliance Foundation Trials, LLC. (1) · ETOP IBCSG Partners Foundation (1) · Fondazione Oncotech (1)
Countries United States (21) · Spain (16) · South Korea (13) · Germany (12) · United Kingdom (12) · Australia (11) · Italy (10) · France (9) · Taiwan (9) · Argentina (8) · Brazil (8) · Canada (8) · China (7) · Poland (7) · Turkey (Türkiye) (7)
Top investigators Antonio Llombart, MD (2) · Elisabetta Munzone, MD (1) · Michelino De Laurentiis, MD (1)
Results publications PMID 37657462 , PMID 37921755 , PMID 38019116 , PMID 38305868 , PMID 38537155 , PMID 38789924 , PMID 40022843 , PMID 40896848 , PMID 42814929
NIH funding 2023 (9) , 2017 (2) , 2018 (1) , 2025 (1)