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 29 | 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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NCT05634499 | Phase II | Giredestrant | A Study of Giredestrant in Participants With Grade 1 Endometrial Cancer (EndomERA) | Recruiting | USA | ITA | CAN | 2 |
| 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 |
| 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 |
| 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) | Active, not recruiting | GBR | ESP | 0 |
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