Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A Phase Ia/Ib, Multicenter, Open-Label, Dose Escalation, Dose Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-9545 Alone or in Combination With Palbociclib and/or LHRH Agonist in Patients With Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer
Study ID: NCT03332797
Conditions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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; Vanderbilt University, Nashville, Tennessee, United States
St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia
Peter Maccallum Cancer Centre, Melbourne, Victoria, Australia
National Cancer Center; Medical Oncology, Gyeonggi-do, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
ICO L'Hospitalet; Servicio de oncologia medica, L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Quiron Barcelona; Servicio de Oncologia, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Centro Oncologioco MD Anderson Internacional; Servicio de Farmacia, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario HM Sanchinarro; South Texas Accelerated Research Therapeutics, Madrid, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Barts Health NHS Trust, London, , United Kingdom
The Royal Marsden NHS Foundation Trust; Oncology, London, , United Kingdom
The Royal Marsden Hospital, Sutton, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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