A Study of E7090 as Monotherapy and in Combination With Other Anticancer Agents in Participants W… (NCT04572295) | Clinical Trial Compass
Active — Not RecruitingPhase 1
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
Japan51 participantsStarted 2020-10-09
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Participants who provided written voluntary informed consent for participation in the study.
✓. Female participants who are age \>=18 years at the time of informed consent.
✓. Post-menopausal or pre/peri-menopausal participants who have been continuously on concurrently given a luteinizing hormone-releasing hormone (LHRH) agonist since before the start of study treatment and is planned to continue this treatment during the study.
✓. Participants with histologically confirmed diagnosis of progressive/recurrent or metastatic, ER+, HER2 negative breast cancer.
✓. Participants who received prior CDK4/6 inhibitor treatment.
✓. Participants with Performance Status (PS) score of 0-1 established by Eastern Cooperative Oncology Group (ECOG).
✓. Part 1 and Part 2: Participants with at least one accessible lesion for biopsy and who agree to undergo a biopsy of accessible lesion prior to study treatment (if archived tissues collected after CDK4/6 inhibitor treatment is not available) and on Day 1 of Cycle 3.
✓. Participants who agree to provide archival or fresh tumor tissue collected after CDK4/6 inhibitor treatment.
Exclusion criteria
✕. 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.
What they're measuring
1
Part 1: Recommended Dose (RD) of E7090 in Combination With Other Anticancer Agents
Timeframe: Up to Cycle 1 (each cycle length = 28 days)
2
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
Timeframe: Up to Cycle 1 (each cycle length = 28 days)
3
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Up to 30 days after last administration of study drug (approximately up to 66 months)
✕. (Part 1 and Part 2) Participant who have received 2 or more regimen of chemotherapy for the treatment of advanced or metastatic lesions.
✕. (Part 3) Participant who have received 1 or more regimens of chemotherapy or antibody-drug conjugate therapy for the treatment of advanced or metastatic lesions.
✕. Participant with inflammatory breast cancer.
✕. Participant with bilateral breast cancer of different histologic types. Participants who have bilateral breast cancers that are both ER+ and HER2- may be enrolled in the study.
✕. Participant who have history of active malignancy within the past 24 months prior to the first dose of study drugs.
✕. Participants with clinically significant cardiovascular impairment.
✕. Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.