Giredestrant

Phase 3Small molecule

Roche

Giredestrant is one of 97 small molecule programs targeting Endometrial Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Endometrial CancerRecruiting

Metastatic Breast CancerRecruiting

Early Breast CancerRecruiting

Inoperable, Locally Advanced or Metastatic, ER-Positive Breast CancerRecruiting

Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast CancerActive, not recruiting

Endometrial CancerPhase 2

Recruiting

Metastatic Breast CancerPreclinical

Recruiting

Early Breast CancerPhase 3

Recruiting

Inoperable, Locally Advanced or Metastatic, ER-Positive Breast CancerPreclinical

Recruiting

Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast CancerPhase 3

Active, not recruiting

Competition

Competitive Landscape

85 competitors in Endometrial Cancer

#DrugCompanyPhaseTrials

Taxol

Teva

Phase 3

52 2

Keytruda

Merck & Co.

Phase 3

21 3

Femara

Novartis

Phase 3

17 4

Paraplatin

AAvyxa

Phase 3

37 5

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

28 6

Megace

Bristol-Myers Squibb

Phase 3

9 7

Lynparza

AstraZeneca

Phase 3

6 8

Lenvima

Eisai

Phase 3

6 9

Tecentriq

Roche

Phase 3

4 10

Depo-Provera

Eli Lilly

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 3Active, not recruiting

Estrogen Receptor (ER)-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

NCT05306340

Q3 2027

Phase 3Active, not recruiting

Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

NCT04546009

Phase 2Active, not recruiting

Locally Advanced or Metastatic Breast Cancer

NCT04576455

Phase 2Recruiting

Breast Cancer

NCT07054190

Q4 2027

Phase 1/2Recruiting

Endometrial Cancer

NCT04486352

Q2 2028

Phase 2Active, not recruiting

Ovarian Cancer

NCT04931342

Clinical

Trials by Indication[1]

Breast Cancer7 trials

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)

Completed· Roche logo

Roche·Phase 2·NCT04436744·221 enrolled

A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer

Completed·EETOP IBCSG Partners Foundation·Phase 2·NCT05896566·231 enrolled

A Study of Giredestrant (GDC-9545) in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer

Completed· Roche logo

Roche·Phase 1·NCT03916744·75 enrolled

Show 4 more trials

A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant Treatment With Inavolisib Combinations in Patients With Untreated, Early-stage, PIK3CA-Mutated Breast Cancer

Recruiting· Roche logo

Roche·Phase 2·NCT07054190·120 enrolled

A Phase Ib/II Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination With Giredestrant in Comparison With Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After a CDK4/6 Inhibitor

Recruiting· Roche logo

Roche·Preclinical·NCT07100106·285 enrolled

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

Active, not recruiting·MMedSIR·Phase 2·NCT05708235·976 enrolled

A Phase Ia/Ib Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Patients With Locally Advanced Or Metastatic ER-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After CDK4/6 Inhibitor Therapy

Terminated· Roche logo

Roche·Phase 1·NCT07214662·3 enrolled

Early Breast Cancer4 trials

A Phase IIIb, Single-arm, Open-Label, Multicenter Study Evaluating the Treatment Adherence, Tolerability, and Patient-Reported Outcomes of Giredestrant in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer

Recruiting· Roche logo

Roche·Phase 3·NCT07827573·1,500 enrolled

AN INTERVENTIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF ATIRMOCICLIB (PF-07220060) PLUS GIREDESTRANT COMPARED TO GIREDESTRANT MONOTHERAPY AS ADJUVANT TREATMENT IN ADULT PARTICIPANTS WITH ESTROGEN RECEPTOR (ER)-POSITIVE, HER2-NEGATIVE EARLY-STAGE BREAST CANCER WITH MEDIUM OR HIGH RISK OF RECURRENCE (FOURLIGHT-4)

Not yet recruiting· Pfizer logo

Pfizer·Phase 3·NCT07890597·3,800 enrolled

A Phase IIIb, Single-Arm, Open-Label Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes (PRO) of Giredestrant in Patients With ER+/HER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy

Recruiting· Roche logo

Roche·Phase 3·NCT07541079·300 enrolled

Show 1 more trial

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 recruiting· Roche logo

Roche·Phase 3·NCT04961996·4,170 enrolled

Endometrial Cancer2 trials

A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer

Recruiting·AAlliance Foundation Trials, LLC.·Phase 1/2·NCT04486352·148 enrolled

A Phase II, Single-Arm Study of Giredestrant in Patients With Grade 1 Endometrial Cancer

Completed· Roche logo

Roche·Phase 2·NCT05634499·33 enrolled

Locally Advanced or Metastatic Breast Cancer2 trials

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 recruiting· Roche logo

Roche·Phase 3·NCT05296798·922 enrolled

A Phase II, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Compared With Physician's Choice of Endocrine Monotherapy in Patients With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Active, not recruiting· Roche logo

Roche·Phase 2·NCT04576455·303 enrolled

Menopausal Women1 trial

Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10%

Completed·MMedSIR·Phase 2·NCT05659563·92 enrolled

8 more indications

Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer1 trial

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS-BREAST CANCER)

Recruiting· Roche logo

Roche·Preclinical·NCT04802759·316 enrolled

Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer1 trial

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 recruiting· Roche logo

Roche·Phase 3·NCT05306340·373 enrolled

Advanced/Metastatic Breast Cancer1 trial

A Multicenter, Open-Label Expanded Access Program to Provide Giredestrant to Patients With ER+, HER2- Early or Metastatic Breast Cancer

Available· Roche logo

Roche··NCT07643831

Metastatic Breast Cancer1 trial

A Phase Ib/II, Open-label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic Breast Cancer (Morpheus-panBC)

Recruiting· Roche logo

Roche·Preclinical·NCT03424005·1,132 enrolled

Advanced or Metastatic Breast Cancer1 trial

A Phase Ib, Multicenter, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer Who Are Sensitive or Resistant to Endocrine Therapy

Not yet recruiting· Roche logo

Roche·Phase 1·NCT07867262·165 enrolled

Advanced Breast Cancer1 trial

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

Active, not recruiting· Roche logo

Roche·Phase 3·NCT06065748·1,050 enrolled

Ovarian Cancer1 trial

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 recruiting· Roche logo

Roche·Phase 2·NCT04931342·176 enrolled

Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer1 trial

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 recruiting· Roche logo

Roche·Phase 3·NCT04546009·992 enrolled

Sources

References

[1]
ClinicalTrials.gov — 24 trial records for Giredestrant. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Giredestrant compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Giredestrant. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Roche

Giredestrant

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Q4 2027

Q2 2028

Trials by Indication[1]

Breast Cancer7 trials

Early Breast Cancer4 trials

Endometrial Cancer2 trials

Locally Advanced or Metastatic Breast Cancer2 trials

Menopausal Women1 trial

Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer1 trial

Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer1 trial

Advanced/Metastatic Breast Cancer1 trial

Metastatic Breast Cancer1 trial

Advanced or Metastatic Breast Cancer1 trial

Advanced Breast Cancer1 trial

Ovarian Cancer1 trial

Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer1 trial

References

Drug Info

Quick Facts

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