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Breast NeoplasmsPhase 1NCT04572295

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

A Phase 1 study testing E7090, Fulvestrant and Exemestane in people with Breast Neoplasms, run by Eisai Co., Ltd. at 11 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
E7090, Fulvestrant and Exemestane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
11 sitesJapan
Study dates
9 Oct 2020to 18 Jun 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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 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.
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  • Participants with clinically significant cardiovascular impairment.
  • Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
  • Concomitant active infection requiring systemic treatment.
  • 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).
  • 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)
  • Participants who received prior treatment with an FGFR inhibitor.
  • 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.
  • Part 3 only: Participants who received 3 or more prior lines of endocrine therapy in advanced/metastatic setting.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Japan11 sites

  • Eisai Trial Site 7

    Chuo-ku, Osaka

  • Eisai Trial Site 3

    Chuo-ku, Tokyo

  • Eisai Trial Site 6

    Kashiwa, Chiba

  • Eisai Trial Site 10

    Kitaadachi-gun, Saitama

  • Eisai Trial Site 1

    Koto-ku, Tokyo

  • Eisai Trial Site 9

    Matsuyama, Ehime

  • Eisai Trial Site 11

    Nagoya, Aichi-ken

  • Eisai Trial Site 4

    Sendai, Miyagi

  • Eisai Trial Site 2

    Shinagawa-ku, Tokyo

  • Eisai Trial Site 8

    Shinjuku-ku, Tokyo

  • Eisai Trial Site 5

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: 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

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.

Being tested
E7090, Fulvestrant, Exemestane
Keywords
E7090, Fulvestrant, Exemestane, Receptors, Fibroblast Growth Factor
Medical subject headings
Breast Neoplasms, Acrocephalosyndactylia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E7090Drug

    E7090 oral tablet.

  • FulvestrantDrug

    Fulvestrant intramuscular injection.

  • ExemestaneDrug

    Exemestane oral tablet.

Study groups in NCT04572295
Study groupRoleWhat they receive
Part 1 Dose Escalation: E7090 + Fulvestrant or ExemestaneExperimentalParticipants will receive E7090 tablets, orally, once daily along with fulvestrant 500 milligram (mg), intramuscular injection on Days 1 and 15 of Cycle 1 and each Day 1 of cycle 2 or later, or along with exemestane 25 mg tablet, orally, once daily in 28 days cycle. Each cycle length equals to (=) 28 days.
Receives: Drug: E7090; Drug: Fulvestrant; Drug: Exemestane
Part 2 Monotherapy: E7090ExperimentalParticipants will receive E7090 tablets, orally, once daily in 28 days cycle. Each cycle length =28 days.
Receives: Drug: E7090
Part 3 Dose Expansion: E7090 + FulvestrantExperimentalParticipants will receive E7090 tablets, orally, once daily along with fulvestrant 500 mg, intramuscular injection on Days 1 and 15 of Cycle 1 and each Day 1 of cycle 2 or later. Each cycle length =28 days. The dose of E7090 for Part 3 in combination with fulvestrant will be determined based on the safety, tolerability, pharmacokinetic (PK), and biomarker data obtained from Part 1.
Receives: Drug: E7090; Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Recommended Dose (RD) of E7090 in Combination With Other Anticancer Agents

    Measured: Up to Cycle 1 (each cycle length = 28 days)

  2. Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)

    DLTs will be assessed based on combination regimen-related adverse events (AEs) occurred during Cycle 1 of Part 1 and the severity of AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    Measured: Up to Cycle 1 (each cycle length = 28 days)

  3. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Safety assessments will consist of monitoring and recording all AEs and SAEs; regular measurement of vital signs and ECG; and regular monitoring of clinical laboratory parameters, body weight and bone density.

    Measured: Up to 30 days after last administration of study drug (approximately up to 66 months)

Secondary outcomes (10)

  1. Cmax: Maximum Observed Plasma Concentration of E7090, its Metabolite (M2) and Exemestane

    Measured: For E7090 and its metabolite (M2)- Parts 1 and 2 Cycle 1 Day 1: 0-24 hours post-dose; For exemestane- Part 1 Cycle 1 Day 1: 0-24 hours post-dose (each cycle length = 28 days)

  2. AUC: Area Under the Plasma Concentration-time Curve of E7090, its Metabolite (M2) and Exemestane

    Measured: For E7090 and its metabolite (M2)- Parts 1 and 2 Cycle 1 Day 1: 0-24 hours post-dose; For exemestane- Part 1 Cycle 1 Day 1: 0-24 hours post-dose (each cycle length = 28 days)

  3. Part 1: Plasma Concentration of Fulvestrant

    Measured: Cycles 2 and 3 Day 1: pre-dose (each cycle length = 28 days)

  4. Objective Response Rate (ORR)

    The ORR will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR is defined as a percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). CR: disappearance of all lesions. PR: For PR, longest diameter will be used for non-lymph target lesions but short axis is measured for lymph lesions. PR: greater than or equal to (>=) 30 percent (%) decrease in sum of diameters of target lesions taking as reference baseline, associated to non-progressive disease (non-PD) response for non-target (NT) lesions.

    Measured: Baseline up to 66 months

  5. Disease Control Rate (DCR)

    DCR will be assessed according to RECIST version 1.1. DCR is defined as a percentage of participants with BOR of CR, PR or stable disease (SD). The BOR of SD has to be observed >=7 weeks from the date of first study dose. CR: disappearance of all lesions. PR: For PR, longest diameter will be used for non-lymph target lesions but short axis is measured for lymph lesions. PR: >=30% decrease in sum of diameters of target lesions taking as reference baseline, associated to non-PD response for NT lesions.

    Measured: Baseline up to 66 months

  6. Clinical Benefit Response (CBR)

    CBR will be assessed according to RECIST version 1.1. CBR is defined as a percentage of participants with BOR of CR, PR or durable SD (dSD) (duration of SD >=23 weeks). CR: disappearance of all lesions. PR: For PR, longest diameter will be used for non-lymph target lesions but short axis is measured for lymph lesions. PR: >=30% decrease in sum of diameters of target lesions taking as reference baseline, associated to non-PD response for NT lesions.

    Measured: Baseline up to 66 months

  7. Progression-free Survival (PFS)

    PFS will be assessed according to RECIST version 1.1. PFS is defined as the time from the date of first dose to the date of first documentation of disease progression or date of death from any cause, whichever occurs first.

    Measured: Baseline up to 66 months

  8. Overall Survival (OS)

    OS is defined as the time from the date of first dose to the date of death from any cause.

    Measured: Baseline up to 66 months

  9. Time to Response (TTR)

    TTR will be assessed according to RECIST version 1.1. TTR is defined as the time from the date of first study dose to the date of first documentation of CR or PR. CR: disappearance of all lesions. PR: For PR, longest diameter will be used for non-lymph target lesions but short axis is measured for lymph lesions. PR: >=30% decrease in sum of diameters of target lesions taking as reference baseline, associated to non-PD response for NT lesions.

    Measured: Baseline up to 66 months

  10. Duration of Response (DOR)

    DOR will be assessed according to RECIST version 1.1. DOR is defined as the time from the date of first documentation of CR or PR to the date of first documentation of disease progression or date of death from any cause, whichever occurs first. CR: disappearance of all lesions. PR: For PR, longest diameter will be used for non-lymph target lesions but short axis is measured for lymph lesions. PR: >=30% decrease in sum of diameters of target lesions taking as reference baseline, associated to non-PD response for NT lesions.

    Measured: Baseline up to 66 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2020
  2. Study start9 Oct 2020
  3. Primary completion18 Jun 2026
  4. Study completion18 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04572295
Sponsor's protocol ID
E7090-J081-102
Status last verified
Jul 2026
First submitted
30 Sep 2020
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Supporting Information: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing E7090, Fulvestrant and Exemestane in people with Breast Neoplasms, run by Eisai Co., Ltd. at 11 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Recommended Dose (RD) of E7090 in Combination With Other Anticancer Agents (time frame: Up to Cycle 1 (each cycle length = 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04572295.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.

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