An Open-label Phase 1b Study of E7090 Monotherapy and in Combination With Other Anticancer Agents in Subjects With Estrogen Receptor Positive (ER+) and Human Epidermal Growth Receptor 2 Negative (HER2-) Recurrent/Metastatic Breast Cancer

Eisai Co., Ltd.0 sites72 target enrollmentAugust 24, 2020

Overview

No summary available.

Registry

who.int

Start Date

August 24, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

Female

Sponsor

•1\. Provide written informed consent.
•2\. Female participants who are age \>\=18 years at the time of informed consent.
•3\. Post\-menopausal or pre/peri\-menopausal female (with medical menopause by treatment with a luteinizing hormone\-releasing hormone (LHRH) agonist).
•4\. Participants with pathologically confirmed diagnosis of recurrent/metastatic, ER\+, HER2 negative breast cancer.
•5\. Participants who have adequate bone marrow and organ function.
•6\. Participants with Performance Status (PS) score of 0\-1 established by Eastern Cooperative Oncology Group (ECOG).
•7\. Participants with at least one accessible lesion for biopsy and who agree to undergo a biopsy of accessible lesion.
•8\. Participants who agree to provide archival or fresh tumor tissue.
•9\. Part 2 only: Participants with FGFR positive tumor.

•1\. Participants with brain or subdural metastases, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (example: radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.
•2\. Participant who have received more than 2 regimen of chemotherapy in the metastatic setting.
•(Part3 only) Participant who have received more than 1 regimen of chemotherapy in the metastatic setting.
•3\. Participant with inflammatory breast cancer.
•4\. Participant with bilateral breast cancer.
•5\. Participant who have history of active malignancy within the past 24 months.
•6\. Participants with clinically significant cardiovascular impairment.
•7\. Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
•8\. Concomitant active infection requiring systemic treatment.
•9\. Participants who test positive for human immunodeficiency virus (HIV antibody), or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV antibody and RNA).

Not specified