CLINICAL TRIALS PROFILE FOR GDC-9545

Clinical Trials for GDC-9545

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT03332797 ↗	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.
NCT03916744 ↗	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.
NCT04274075 ↗	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.
NCT04436744 ↗	A Study Evaluating 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 (coopE	Active, not recruiting	Hoffmann-La Roche	Phase 2	This is a randomized, multicenter, open-label, two-arm, Phase II study to evaluate the efficacy, safety, and pharmacokinetics of giredestrant versus anastrozole (in the window-of-opportunity phase) and giredestrant plus palbociclib compared with anastrozole plus palbociclib (in the neoadjuvant phase) in postmenopausal women with untreated, estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, early breast cancer. The study consists of a screening period of up to 28 days, a window-of-opportunity phase for 14 days, followed by a neoadjuvant treatment phase for 16 weeks (four 28-day cycles), surgery, and an end of study visit (28 days after the final dose of study treatment).
NCT04546009 ↗	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 (perse	Recruiting	Hoffmann-La Roche	Phase 3	This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.
NCT04576455 ↗	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 (acel	Recruiting	Hoffmann-La Roche	Phase 2	This Phase II, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant compared with physician's choice of endocrine monotherapy in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have received one or two prior lines of systemic therapy in the locally advanced or metastatic setting.
NCT04680273 ↗	Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-9545 Following a Single Oral Dose (Part 1) and to Evaluate the Absolute and Relative Bioavailability of Oral Capsule Formulations of GDC-9545 (Part 2) in Healthy Female Subj	Completed	Genentech, Inc.	Phase 1	This is an open-label, single-center, two part study in healthy female subjects of non-childbearing potential to investigate the absorption, metabolism, and excretion of [14C]-GDC-9545 (Part 1), the absolute bioavailability of formulations F12 and F18 (i.e., GDC-9545/F12 capsule, 30 mg and GDC-9545/F18 capsule, 30 mg) and relative bioavailability of GDC-9545 oral capsule F18 to the F12 formulation (Part 2). It is planned that Part 1 will begin prior to Part 2 of the study, and that the two parts of the study will partially overlap.

Clinical Trial Conditions for GDC-9545

Condition Name

Condition Name for
Intervention	Trials
Breast Cancer	4
Early Breast Cancer	2
Healthy Volunteers	2
Breast Cancer, Early-Onset	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Breast Neoplasms	11
Endometrial Neoplasms	1

Clinical Trial Locations for GDC-9545

Trials by Country

Trials by Country for
Location	Trials
United States	54
Australia	20
Spain	17
Russian Federation	12
Brazil	11

Trials by US State

Trials by US State for
Location	Trials
Massachusetts	5
California	4
Florida	3
Tennessee	3
New York	3

Clinical Trial Progress for GDC-9545

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	4
Phase 2	5
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Not yet recruiting	5
Recruiting	4
Completed	3

Clinical Trial Sponsors for GDC-9545

Sponsor Name

Sponsor Name for
Sponsor	Trials
Hoffmann-La Roche	7
Genentech, Inc.	5
MedSIR	2

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	12
Other	2