NCT04572295CompletedPhase 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
An Open-label Phase 1b Study of E7090 Monotherapy and in Combination With Other Anticancer Agents in Subjects With ER+, HER2- Recurrent/Metastatic Breast Cancer
Source: ClinicalTrials.gov · Last updated 17 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 51 (actual)
- First submitted
- 30 Sept 2020
- Start date
- 9 Oct 2020
- Primary completion date
- 18 Jun 2026
- Lead sponsor
- Eisai Co., Ltd.
- Diseases
- Metastatic breast cancer
- NCT number
- NCT04572295
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 51
- From 9 Oct 2020 to the primary completion date, 18 Jun 2026
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- (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 who have history of active malignancy within the past 24 months prior to the first dose of study drugs.
- Concomitant active infection requiring systemic treatment.
- Participants who received prior treatment with an FGFR inhibitor.
- Part 3 only: Participants who received 3 or more prior lines of endocrine therapy in advanced/metastatic setting.
Other illness
- 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.
- Participants with clinically significant cardiovascular impairment.
- Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
- 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).
Age
- Participants with following ocular disorders:
- Current evidence of Grade 2 or higher corneal disorder.
- Current evidence of active retinopathy (example. age-related macular degeneration, central serous chorioretinal disease, retinal tear)
Other
- Females who are pregnant or breastfeeding.
- Part 1 only: Participants with T-score less than (\<) -2.5 by dual-energy X-ray absorptiometry (DXA) scan.
Who the study is looking for
- Common to Part 1, 2 and 3
- 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.
- (Part 3) participants must agree to undergo a biopsy at screening if no archival tissue is available (tissue collection must be after CDK4/6 inhibitor treatment and prior to study treatment). A biopsy on Day 1 of Cycle 3 is not mandatory.
- Participants who agree to provide archival or fresh tumor tissue collected after CDK4/6 inhibitor treatment.
- Part 2 only: Participants with positive protein expression of fibroblast growth factor receptor 1 (FGFR) and/or FGFR2, with which tumor was collected after CDK4/6 inhibitor treatment at the central laboratory.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Kashiwa | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Kitaadachi-gun | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Koto-ku | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Shinagawa-ku | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.