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A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer
Sponsor: Eisai Inc.
Summary
The primary objective of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of this combination in women with advanced or metastatic estrogen receptor-positive (ER+) HER2- breast cancer.
Official title: An Open-Label Multicenter Phase 1b Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive HER2-Negative Breast Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
31
Start Date
2020-04-01
Completion Date
2027-03-31
Last Updated
2026-02-27
Healthy Volunteers
No
Interventions
Palbociclib (75, 100, 125 milligram [mg])
Palbociclib orally, once daily (QD).
H3B-6545 (150, 300, 450 mg)
H3B-6545 orally, QD.
Locations (8)
Florida Cancer Specialists South - SCRI - PPDS
Sarasota, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Tennessee Oncology, PLLC - SCRI - PPDS
Nashville, Tennessee, United States
Royal Marsden NHS Foundation Trust
London, United Kingdom
Sarah Cannon Research Institute UK - SCRI
London, United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, United Kingdom