CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 31 enrolled
Drug / intervention
Palbociclib (75, 100, 125 milligram [mg]) +1 moredrug
Likely dose
Palbociclib (75, 100, 125 milligram [mg])from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04288089
NCT04288089Phase 1Active
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An Open-Label Multicenter Phase 1b Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive HER2-Negative Breast Cancer

Eisai Inc.·interventional·Posted Feb 27, 2020·Updated Feb 27, 2026

In Brief

A Phase 1 clinical trial evaluating Palbociclib (75, 100, 125 milligram [mg]) and H3B-6545 (150, 300, 450 mg) for Receptors, Estrogen and 2 related conditions. Active but no longer recruiting, targeting 31 participants across 8 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsReceptors, Estrogen, Genes, Erbb-2, Breast Neoplasms
CountriesUnited Kingdom, United States
Collaborators--

Timeline

Phase 1Active
20202021202220232024202520262027
First PostedFeb 27, 2020
Enrollment StartApr 1, 2020
Primary CompletionSep 16, 2022
Study CompletionMar 31, 2027
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.3 years ago

Interventions

Palbociclib (75, 100, 125 milligram [mg])drug

Palbociclib orally, once daily (QD).

H3B-6545 (150, 300, 450 mg)drug

H3B-6545 orally, QD.