Therapy Detail

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Therapy Name Giredestrant
Synonyms
Therapy Description

Giredestrant (GDC-9545) is a selective estrogen receptor degrader (SERD) that prevents cell proliferation of ER-positive cells (Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020) 1023-1023).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Giredestrant RG6171|GDC9545|GDC 9545|GDC-9545) Hormone - Anti-estrogens 25 Giredestrant (GDC-9545) is a selective estrogen receptor degrader (SERD) that prevents cell proliferation of ER-positive cells (Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020) 1023-1023).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03332797 Phase I Giredestrant + Palbociclib Giredestrant A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer Active, not recruiting USA | GBR | ESP | AUS 1
NCT04961996 Phase III Exemestane Giredestrant Letrozole Anastrozole 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) Recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 43
NCT04802759 Phase Ib/II Abemaciclib + Giredestrant Giredestrant + Ipatasertib Giredestrant Everolimus + Giredestrant Giredestrant + Inavolisib Giredestrant + Ribociclib A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer Recruiting USA | ESP | AUS 2
NCT05634499 Phase II Giredestrant A Study of Giredestrant in Participants With Grade 1 Endometrial Cancer (EndomERA) Recruiting USA | ITA | CAN 1
NCT03916744 Phase I Giredestrant A Study of GDC-9545 in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer Completed USA | GBR | ESP | BEL | AUS 0
NCT05896566 Phase II Anastrozole + Triptorelin Giredestrant + Triptorelin Giredestrant A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer (PREcoopERA) Recruiting ITA | FRA | ESP | DEU 4
NCT05659563 Phase II Tamoxifen Giredestrant Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67>=10% (EMPRESS) Recruiting FRA | ESP 0
NCT05708235 Phase II Giredestrant + Inavolisib Abemaciclib + Giredestrant Giredestrant A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population (MiRaDoR) Recruiting ESP 0
NCT04576455 Phase II Fulvestrant Giredestrant 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 USA | GBR | DEU | AUS 13


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