drugset / Trial / NCT04572295

A Study of E7090 as Monotherapy and in Combination With Other Anticancer Agents in Participants With Estrogen Receptor Positive (ER+) and Human Epidermal Growth Receptor 2 Negative (HER2-) Recurrent/Metastatic Breast Cancer

NCT04572295

Phase 1 Completed 51 enrolled Eisai Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary purpose of this study is to evaluate the tolerability and safety of E7090 as monotherapy and in combination with other anticancer agents in participants with ER+, HER2- recurrent/metastatic breast cancer and to determine the recommended dose (RD) of E7090 in combination with other anticancer agents for subsequent phase studies.

Timeline

Start
2020-10-09
Primary completion
2026-06-18
Completion
2026-06-18

Drugs

EvaluationDrugModalityDoseRoute
Subject E7090 Small molecule Oral
Background Exemestane Small molecule 25 mg Oral
Background Fulvestrant Small molecule 500 mg Intramuscular

Indications