Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Eisai Inc.
Conditions:
Receptors, Estrogen
Genes, Erbb-2
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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/o...
Eligibility Criteria
Inclusion
- ER+ HER2- locally advanced, recurrent, or metastatic breast cancer, as per local laboratory
- Prior therapy in the advanced/metastatic setting
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Has adequate bone marrow and organ function
Exclusion
- Uncontrolled significant active infections
- Major surgery or other locoregional treatment within 4 weeks before the 1st dose of study drug
- Inability to take oral medication or presence of malabsorption
- Active cardiac disease or a history of cardiac dysfunction
- Evidence of ongoing Alcohol or Drug Abuse
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04288089
Start Date
April 1 2020
End Date
March 31 2026
Last Update
August 3 2025
Active Locations (8)
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1
Florida Cancer Specialists South - SCRI - PPDS
Sarasota, Florida, United States, 34232
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
4
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169