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Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

A Phase 1 Study of H3B-6545 in Japanese Women With Estrogen Receptor-positive, HER2 Negative Breast Cancer

NCT04568902•Eisai Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of study is to determine tolerability and safety profile of H3B-6545 in Japanese women with ER-positive, HER2-negative breast cancer, and also to confirm the dose applicability to Japanese.

Eligibility

Age

20 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Participant has a histologically and/or cytologically confirmed diagnosis of ER-positive, HER2-negative breast cancer.
•Note: Status of ER and HER2 should be diagnosed by method approved by regulatory authority
•2. Only females, age greater than or equal to (\>=) 20 years at the time of informed consent.
•3. Prior therapy for breast cancer in the adjuvant and/or advanced/metastatic setting must have included a minimum of:
•1. two prior hormonal therapies, or
•2. one prior hormonal therapy and one prior chemotherapy regimen, or
•3. one prior hormonal therapy and a cyclin-dependent kinase (CDK4/6) inhibitor.
•4. Participant has an ECOG-PS of 0 or 1.
•5. Participant has adequate bone marrow and organ function, as defined by the following laboratory values:
•* Absolute neutrophil count (ANC) \>=1.5\*10˄9/liter (L).
+10 more criteria

Exclusion Criteria

•1. Participant with inflammatory breast cancer.
•2. Participant is currently receiving or has received systemic corticosteroids \<=2 weeks prior to starting study drug, or has not fully recovered from side effects of such treatment.
•Note: The following uses of corticosteroids are permitted: inhaled sprays (example- for obstructive airways diseases), eye drops or local injections (example- intra-articular).
•3. Washout period required from the end of prior treatment to the first administration of study drug will be as follows.
•1. Anti-cancer therapy
•* Antibody and other study drugs: greater than (\>) 4 weeks (however, in the case where the half-life of other study drugs is known and 5\*half-lives of that study drug is less than or equal to 4 weeks, participants can be eligible after \>=5\*half-lives of that study drug has passed).
•* Prior chemotherapy (except small-molecule targeted therapy), surgical therapy, radiation therapy: \>3 weeks.
•* Endocrine therapy, immunotherapy (except antibody drug), small-molecule targeted therapy: \>2 weeks.
•2. Supportive therapy • Blood/platelet transfusion, hematopoietic stimulating agent including granulocyte colony-stimulating factor (G-CSF) formulation: \>2 weeks.
•4. Participant has active cardiac disease or a history of cardiac dysfunction, including any of the following:
+25 more criteria

Locations (2)

Eisai Trial Site 2

Chūōku, Japan

Eisai Trial Site 1

Kōtoku, Japan

Key Dates

Start Date

September 30, 2020

Primary Completion Date

October 1, 2025

Completion Date

October 1, 2025

Last Updated

October 23, 2025

Enrollment

ACTUAL participants

Conditions

Breast Neoplasms

Interventions

H3B-6545

DRUG

Antihistamine

DRUG

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

NCT07191730

CardiotoxicityHeart Failure+2 more

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RECRUITINGPHASE2

Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

NCT06797635

Breast NeoplasmsBreast Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

Inclusion Criteria

Exclusion Criteria

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

Evaluation of Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients

Dissemination of BREASTChoice AIM1-B

Role of Sodium-glucose Linked Transporter 2 (SGLT2) and Its Inhibitor Over CARdiotoxicity Induced by Anthracyclines and Breast Cancer Tumorigenesis SCARA-B