Giredestrant

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Breast CancerEndometrial CancerAdvanced Breast CancerEarly Breast CancerInoperable, Locally Advanced or Metastatic, ER-Positive Breast Cancer

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

1

Giredestrant

Roche

Phase 3

102

Tecentriq

Roche

Preclinical

363

Halaven

Eisai

Preclinical

384

Tykerb

GSK

Preclinical

805

DATROWAY

Daiichi Sankyo

Preclinical

46

MS Contin

Merck & Co.

Preclinical

27

Zolymbus

AbbVie

Preclinical

18

Lupron

EEastern Cooperative Oncology Group

Preclinical

59

Effexor

WWyeth-Lederle Vaccines

Preclinical

210

Aquasol E

NNational Eye Institute (NEI)

Preclinical

—Show 17 more competitors

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Breast Cancer10 trials

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 recruiting·Roche·Phase 2·NCT04576455·303 enrolled

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 recruiting·Roche·Phase 3·NCT05306340·373 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

Show 7 more trials

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 recruiting·Roche·Phase 3·NCT04546009·992 enrolled

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·Phase 2·NCT04436744·221 enrolled

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 recruiting·Roche·Phase 3·NCT05296798·922 enrolled

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 recruiting·Roche·Phase 3·NCT04961996·4,170 enrolled

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

Completed·Roche·Phase 1·NCT03916744·75 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·Preclinical·NCT07100106·285 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

Recruiting·Roche·Phase 1·NCT07214662·136 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

Active, not recruiting·Roche·Phase 2·NCT05634499·30 enrolled

Efficacy and Safety1 trial

A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

Active, not recruiting·Roche·Phase 2·NCT04931342·176 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

HER2-Negative1 trial

A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population

Recruiting·MMedSIR·Phase 2·NCT05708235·976 enrolled

3 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·Preclinical·NCT04802759·316 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

Recruiting·Roche·Phase 3·NCT06065748·1,050 enrolled

Early Breast Cancer1 trial

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

Not yet recruiting·Roche·Phase 3·NCT07541079·300 enrolled

Details

Drug Info

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