Trials / Completed
CompletedNCT04568902
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Eisai Co., Ltd. · Industry
- Sex
- Female
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | H3B-6545 | H3B-6545 oral tablets. |
| DRUG | Antihistamine | Systemic antihistamine oral drug such as fexofenadine, loratadine and cetirizine. |
Timeline
- Start date
- 2020-09-30
- Primary completion
- 2025-10-01
- Completion
- 2025-10-01
- First posted
- 2020-09-29
- Last updated
- 2025-10-23
Locations
2 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT04568902. Inclusion in this directory is not an endorsement.