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

  • End date
    Mar 31, 2024
  • participants needed
  • sponsor
    H3 Biomedicine Inc.
Updated on 10 November 2021
breast cancer
growth factor
epidermal growth factor receptor
stage iv breast cancer
epidermal growth factor
estrogen receptor
her2/neu-negative breast cancer


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.

Condition breast tumor, Breast Cancer, ERBB2 gene, breast tumors, tumor of the breast, estrogen receptor
Treatment Palbociclib (75, 100, 125 milligram [mg]), H3B-6545 (300, 450 mg), H3B-6545 (150, 300, 450 mg)
Clinical Study IdentifierNCT04288089
SponsorH3 Biomedicine Inc.
Last Modified on10 November 2021


Yes No Not Sure

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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