Breast Cancer Clinical Trial
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
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.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
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There are 5 Locations for this study
Sarasota Florida, 34232, United States
Boston Massachusetts, 02114, United States
Kansas City Missouri, 64111, United States
Las Vegas Nevada, 89169, United States
Nashville Tennessee, 37203, United States
London , , United Kingdom
London , , United Kingdom
Sutton , , United Kingdom
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