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
Running, not enrolling · Phase 1
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT03332797
- Run by
- Genentech, Inc.
- People needed
- 181
- Starts
- 2017-11-24
- Expected to finish
- 2027-07-31
- Last updated by the study team
- 2026-05-15
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
Where it is running
- University of Colorado — Aurora, Colorado, United States
- Massachusetts General Hospital. — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- St Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia
- Peter Maccallum Cancer Centre — Melbourne, Victoria, Australia
- National Cancer Center — Gyeonggi-do, South Korea
- Seoul National University Hospital — Seoul, South Korea
- Severance Hospital, Yonsei University Health System — Seoul, South Korea
- Asan Medical Center — Seoul, South Korea
- Samsung Medical Center — Seoul, South Korea
- ICO L'Hospitalet — L'Hospitalet de Llobregat, Barcelona, Spain
- Hospital Quiron Barcelona — Barcelona, Spain
- Hospital Universitari Vall d'Hebron — Barcelona, Spain
- Hospital General Universitario Gregorio Maranon — Madrid, Spain
- Centro Oncologioco MD Anderson Internacional — Madrid, Spain
- Hospital Universitario Ramón y Cajal — Madrid, Spain
- Hospital Universitario HM Sanchinarro — Madrid, Spain
- Hospital Clinico Universitario de Valencia — Valencia, Spain
- Barts Health NHS Trust — London, United Kingdom
- The Royal Marsden Hospital — Suttton, United Kingdom
Full record on ClinicalTrials.gov
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