A Study of E7090 as Monotherapy and in Combination With Other Anticancer Agents in Participants With ER+ and HER2- Recurrent/Metastatic Breast Cancer
- Conditions
- ER+ and HER2- Recurrent/Metastatic Breast Cancer
- Registration Number
- JPRN-jRCT2080225333
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Female
- Target Recruitment
- 72
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).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Dose Limiting Toxicity(DLT)<br>Adeverse Event, Serious Adverse Event
- Secondary Outcome Measures
Name Time Method efficacy<br>pharmacokinetics<br>BOR,ORR,DCR,CBR,PFS,OS<br>Cmax,tmax,AUC