ER+ and HER2- Recurrent/Metastatic Breast Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : E7090
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material :
Sponsors
Eisai Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 2 or more regimen of chemotherapy in the metastatic setting. (Part3 only) Participant who have received 1 or more regimen of chemotherapy or antibody-drug conjugate therapy 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). 10. Participants with following ocular disorders: a. Current evidence of Grade 2 or higher corneal disorder b. Current evidence of active retinopathy (example. age-related macular degeneration, central serous chorioretinal disease, retinal tear). 11. Participants who received prior treatment with an FGFR inhibitor. 12. Females who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Dose Limiting Toxicity(DLT) Adeverse Event, Serious Adverse Event | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics BOR,ORR,DCR,CBR,PFS,OS Cmax,tmax,AUC | — |
Countries
Japan
Outcome results
None listed