NCT04288089View on ClinicalTrials.gov

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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

April 1, 2020

Primary Completion Date

September 16, 2022

Study Completion Date

March 31, 2026

Conditions
Receptors, EstrogenGenes, Erbb-2Breast Neoplasms
Interventions
DRUG

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

Palbociclib orally, once daily (QD).

DRUG

H3B-6545 (150, 300, 450 mg)

H3B-6545 orally, QD.

Trial Locations (8)

34232

Florida Cancer Specialists South - SCRI - PPDS, Sarasota

37203

Tennessee Oncology, PLLC - SCRI - PPDS, Nashville

64111

Saint Luke's Cancer Institute, Kansas City

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

02114

Massachusetts General Hospital, Boston

Unknown

Royal Marsden NHS Foundation Trust, London

Sarah Cannon Research Institute UK - SCRI, London

Royal Marsden NHS Foundation Trust, Sutton

All Listed Sponsors
lead

Eisai Inc.

INDUSTRY

NCT04288089 - 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 | Biotech Hunter | Biotech Hunter