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
Running, not enrolling · Phase 1
Conditions studied: Receptors, Estrogen, Genes, Erbb-2, Breast Neoplasms
In brief
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.
Key facts
- Study ID
- NCT04288089
- Run by
- Eisai Inc.
- People needed
- 31
- Starts
- 2020-04-01
- Expected to finish
- 2027-03-31
- Last updated by the study team
- 2026-02-27
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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