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ACTIVE NOT RECRUITING
NCT04572295
PHASE1

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

Sponsor: Eisai Co., Ltd.

View on ClinicalTrials.gov

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

51

Start Date

2020-10-09

Completion Date

2027-03-31

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

DRUG

E7090

E7090 oral tablet.

DRUG

Fulvestrant

Fulvestrant intramuscular injection.

DRUG

Exemestane

Exemestane oral tablet.

Locations (11)

Eisai Trial Site 11

Nagoya, Aichi-ken, Japan

Eisai Trial Site 6

Kashiwa, Chiba, Japan

Eisai Trial Site 9

Matsuyama, Ehime, Japan

Eisai Trial Site 5

Yokohama, Kanagawa, Japan

Eisai Trial Site 4

Sendai, Miyagi, Japan

Eisai Trial Site 7

Chuo-ku, Osaka, Japan

Eisai Trial Site 10

Kitaadachi-gun, Saitama, Japan

Eisai Trial Site 3

Chuo-ku, Tokyo, Japan

Eisai Trial Site 1

Koto-ku, Tokyo, Japan

Eisai Trial Site 2

Shinagawa-ku, Tokyo, Japan

Eisai Trial Site 8

Shinjuku-ku, Tokyo, Japan