Active — Not RecruitingPhase 1

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

United States31 participantsStarted 2020-04-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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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

What they're measuring

Maximum Tolerated Dose (MTD) of H3B-6545 and Palbociclib

Timeframe: Cycle 1 (Cycle length = 28 Days)

Trial details

NCT IDNCT04288089

SponsorEisai Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-16

Results submitted2023-09-15

View on ClinicalTrials.gov More Receptors, Estrogen trials