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

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: Female

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 also to determine the recommended dose (RD) of E7090 in combination with other anticancer agents for subsequent phase studies.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Co., Ltd.
• Treatments: Exemestane; Fulvestrant

Criteria

Inclusion Criteria:

1. Provide written informed consent.

2. Female participants who are age >=20 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 and 3 only: Participants with fibroblast growth factor receptor (FGFR) positive tumor.

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 more than 2 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:

1. Current evidence of Grade 2 or higher corneal disorder

2. 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.