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

Summary

This study will evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of GDC-9545 as a single agent and in combination with palbociclib and/or luteinizing hormone-releasing hormone (LHRH) agonist in participants with advanced or metastatic estrogen receptor (ER)-positive (human epidermal growth factor receptor 2 \[HER2\]-negative) breast cancer.

Timeline

Start

2017-11-24

Primary completion

2027-07-31

Completion

2027-07-31

Publications

• Malhi V, Agarwal P, Gates MR, Liu L, Wang J, De Bruyn T, Lam S, Eng-Wong J, Perez-Moreno P, Chen YC, Yu J. Optimizing Early-stage Clinical Pharmacology Evaluation to Accelerate Clinical Development of Giredestrant in Advanced Breast Cancer. Cancer Res Commun. 2023 Dec 15;3(12):2551-2559. doi: 10.1158/2767-9764.CRC-23-0324.
• Jhaveri KL, Bellet M, Turner NC, Loi S, Bardia A, Boni V, Sohn J, Neilan TG, Villanueva-Vazquez R, Kabos P, Garcia-Estevez L, Lopez-Miranda E, Perez-Fidalgo JA, Perez-Garcia JM, Yu J, Fredrickson J, Moore HM, Chang CW, Bond JW, Eng-Wong J, Gates MR, Lim E. Phase Ia/b Study of Giredestrant +/- Palbociclib and +/- Luteinizing Hormone-Releasing Hormone Agonists in Estrogen Receptor-Positive, HER2-Negative, Locally Advanced/Metastatic Breast Cancer. Clin Cancer Res. 2024 Feb 16;30(4):754-766. doi: 10.1158/1078-0432.CCR-23-1796.

Drugs

Indications