OncRef

Clinical 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

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Eisai Co., Ltd.
Information Provided By:Eisai Inc.
Last Update Posted:2026-07-17

Study Overview

Brief 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.

Official Title

An Open-label Phase 1b Study of E7090 Monotherapy and in Combination With Other Anticancer Agents in Subjects With ER+, HER2- Recurrent/Metastatic Breast Cancer

Conditions

Breast Neoplasms

Intervention / Treatment

  • Drug: E7090
  • Drug: Fulvestrant
  • Drug: Exemestane

Other Study ID Numbers

  • E7090-J081-102

Start Date (Actual)

2020-10-09

Primary Completion Date (Actual)

2026-06-18

Study Completion Date (Actual)

2026-06-18

Enrollment (Actual)

51

Study Type

Interventional

Phase

Phase 1