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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    36
  • sponsor
    H3 Biomedicine Inc.
Updated on 10 November 2021
cancer
estrogen
breast cancer
growth factor
epidermal growth factor receptor
HER2
EGFR
stage iv breast cancer
erbb2
epidermal growth factor
estrogen receptor
palbociclib
mammogram
her2/neu-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.

Details
Condition Breast Cancer, ERBB2 gene, estrogen receptor, breast tumors, tumor of the breast, breast tumor
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

Eligibility

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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