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RO7197597

DRUG12 trials

Sponsors

F. Hoffmann-La Roche AG, ETOP IBCSG Partners Foundation, Medica Scientia Innovation Research S.L., Medica Scientia Innovation Research S.L., Medica Scientia Innovation Research S.L., Genentech Inc.

Conditions

ER-positiveER-positive/HER2-negative early breast cancerER[+]/HER2[-] & Ki67≥10% early breast cancer (EBC)ESTROGEN RECEPTOR-POSITIVEEarly-stageEstrogen Receptor (ER)-PositiveEstrogen Receptor-PositiveEstrogen receptor (ER)-positive

Phase 1

Phase 2

PREOPERATIVE WINDOW OF OPPORTUNITY STUDY WITH GIREDESTRANT (GDC-9545) OR TAMOXIFEN IN PREMENOPAUSAL WOMEN WITH ER[+]/HER2[-] & KI67≥10% EARLY BREAST CANCER
CompletedCTIS2023-503565-36-00
Medica Scientia Innovation Research S.L., Medica Scientia Innovation Research S.L.ER[+]/HER2[-] & Ki67≥10% early breast cancer (EBC)
Start: 2023-07-19End: 2025-01-30Target: 92Updated: 2024-08-07
IBCSG 67-22 PREcoopERA: A Window-of-Opportunity trial of giredestrant +/- triptorelin vs. anastrozole + triptorelin in premenopausal patients with ER-positive/HER2-negative early breast cancer.
CompletedCTIS2022-503013-32-00
ETOP IBCSG Partners FoundationER-positive/HER2-negative early breast cancer
Start: 2024-01-29End: 2025-09-18Target: 175Updated: 2025-08-26
A Phase II, Open-Label, Multicenter, Platform Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients with Persistent or Recurrent Rare Epithelial Ovarian Tumors
Active, not recruitingCTIS2023-508194-89-00
F. Hoffmann-La Roche AGPersistent or Recurrent Rare Epithelial Ovarian Tumors
Start: 2021-08-30Target: 57Updated: 2026-01-06
A proof of concept study to evaluate treatments´efficacy by monitoring Minimal Residual Disease using ctDNA in HR-positive/HER2-negative early breast cancer population. -The MIRADOR study-
RecruitingCTIS2023-505661-89-00
Medica Scientia Innovation Research S.L.breast cancer (BC), Early-stage, Hormone Receptor (HR)-positive / Human Epidermal Growth Factor Receptor 2 (HER2)-negative
Start: 2025-12-19Target: 1071Updated: 2026-01-20
A Phase II, Single-Arm Study of Giredestrant in Patients with Grade 1 Endometrial Cancer
Active, not recruitingCTIS2023-504091-23-00
F. Hoffmann-La Roche AGGrade 1 Endometrial Cancer
Start: 2023-03-14Target: 9Updated: 2025-10-10
NEOadjuvant Abemaciclib and GIredestrant triaL in patients with ER-positive, HER2-negative Early breast cancer
RecruitingCTIS2023-510153-42-00
Fondazione Oncotech Impresa SocialeER-positive, HER2-negative Early breast cancer
Start: 2024-11-25Target: 51Updated: 2024-08-02

Phase 3

A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF GIREDESTRANT IN COMBINATION WITH PHESGO VERSUS PHESGO AFTER INDUCTION THERAPY WITH PHESGO+TAXANE IN PATIENTS WITH PREVIOUSLY UNTREATED HER2-POSITIVE, ESTROGEN RECEPTOR-POSITIVE LOCALLY-ADVANCED OR METASTATIC BREAST CANCER
Active, not recruitingCTIS2022-500014-26-00
F. Hoffmann-La Roche AGLocally-Advanced unresectable or Metastatic breast cancer (MBC)
Start: 2022-06-24Target: 218Updated: 2026-01-27
A Phase III, Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared with Fulvestrant, both Combined with a CDK4/6 Inhibitor, in Patients with Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer with Resistance to Prior Adjuvant Endocrine Therapy
RecruitingCTIS2022-502980-39-00
F. Hoffmann-La Roche AGEstrogen receptor (ER)-positive, HER2-negative advanced breast cancer
Start: 2024-01-25Target: 296Updated: 2026-01-13
A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF GDC-9545 COMBINED WITH PALBOCICLIB COMPARED WITH LETROZOLE COMBINED WITH PALBOCICLIB IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
Active, not recruitingCTIS2023-506911-16-00
F. Hoffmann-La Roche AGESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
Start: 2020-12-04Target: 259Updated: 2025-12-16
A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared with the Physician’s Choice of Endocrine Therapy Plus Everolimus in Patients with Estrogen Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer
Active, not recruitingCTIS2023-506821-12-00
Genentech Inc.Estrogen Receptor (ER)-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer previously treated with a CDK4/6 inhibitor and endocrine therapy
Start: 2023-10-12Target: 59Updated: 2025-12-17
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 recruitingCTIS2023-507172-44-00
F. Hoffmann-La Roche AGEstrogen Receptor-Positive, HER2-Negative Early Breast Cancer
Start: 2021-09-10Target: 1482Updated: 2025-11-25

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