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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.
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
Conditions
Interventions
E7090
E7090 oral tablet.
Fulvestrant
Fulvestrant intramuscular injection.
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