Giredestrant
Sponsors
Genentech, Inc., Hoffmann-La Roche, Alliance Foundation Trials, LLC., MedSIR, ETOP IBCSG Partners Foundation
Conditions
Breast CancerBreast Cancer, Early-OnsetCancerEarly Breast CancerEndometrial CancerEstrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast CancerEstrogen Receptor-Positive, HER2-Negative Advanced Breast CancerEstrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
Phase 1
A Study of Giredestrant (GDC-9545) in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer
CompletedNCT03916744
Start: 2019-07-26End: 2021-05-25Updated: 2023-03-10
A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer
RecruitingNCT04486352
Start: 2021-10-20End: 2027-10-01Target: 148Updated: 2026-04-01
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
RecruitingNCT04802759
Start: 2021-06-22End: 2029-05-30Target: 316Updated: 2026-05-11
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
RecruitingNCT07100106
Start: 2025-10-07End: 2028-08-31Target: 285Updated: 2026-05-18
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
RecruitingNCT07214662
Start: 2026-01-13End: 2030-06-01Target: 136Updated: 2026-05-04
Phase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)
CompletedNCT04436744
Start: 2020-09-04End: 2021-11-24Updated: 2023-02-02
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)
Active, not recruitingNCT04576455
Start: 2020-11-27End: 2027-08-25Updated: 2026-03-20
A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors
Active, not recruitingNCT04931342
Start: 2021-10-07End: 2028-05-30Updated: 2026-03-10
A Study of Giredestrant in Participants With Grade 1 Endometrial Cancer
Active, not recruitingNCT05634499
Start: 2023-06-27End: 2026-08-28Target: 30Updated: 2026-04-13
Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10%
CompletedNCT05659563
Start: 2023-07-20End: 2025-01-30Updated: 2026-03-19
A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population
RecruitingNCT05708235
Start: 2024-04-01End: 2028-06-30Target: 976Updated: 2026-03-05
A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer
CompletedNCT05896566
Start: 2024-01-23End: 2025-09-18Updated: 2026-02-24
Phase 3
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)
Active, not recruitingNCT04546009
Start: 2020-10-09End: 2028-03-25Updated: 2026-05-19
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)
Active, not recruitingNCT04961996
Start: 2021-08-27End: 2033-09-30Updated: 2026-05-22
A Phase III, Randomized, Open-label, Multicenter Study Evaluating The Efficacy And Safety Of Adjuvant Giredestrant Compared With Physician's Choice Of Adjuvant Endocrine Monotherapy In Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer
Active, not recruitingPACTR202108821955108
Start: 2022-03-03Target: 4100Updated: 2026-01-27
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)
Active, not recruitingNCT05296798
Start: 2022-07-18End: 2030-12-31Target: 922Updated: 2026-04-16
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)
Active, not recruitingNCT05306340
Start: 2022-08-03End: 2026-10-15Updated: 2026-04-30
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)
RecruitingNCT06065748
Start: 2023-12-11End: 2029-02-12Target: 1050Updated: 2026-05-05
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)
RecruitingPACTR202312893558608
Start: 2024-01-15Target: 10Updated: 2026-01-27
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)
Not yet recruitingNCT07541079
Start: 2026-06-30End: 2034-06-30Target: 300Updated: 2026-05-22
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