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
Genentech, Inc.
Phase 1
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.
A Study of Giredestrant (GDC-9545) in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer
Completed
Genentech, Inc.
Phase 1
This study will evaluate the pharmacodynamics, pharmacokinetics, safety, and biologic
activity of giredestrant in participants with Stage I-III operable estrogen receptor
(ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, untreated breast
cancer.
Evaluation of the Relative Bioavailability and Food Effect of GDC-9545 in Healthy Females of Non-Childbearing Potential
Completed
Genentech, Inc.
Phase 1
This study will be an open-label, randomized, three-period, six-sequence crossover study of
GDC-9545 administered to healthy females of non-childbearing potential to determine the
relative bioavailability of the Phase 3 capsule formulation to the Phase 1 tablet formulation
in the fasted state and the effect of food on the Phase 3 capsule formulation.
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