estrogen receptor-positive, HER2 negative breast cancer
Conditions
Interventions
investigational material(s)
Generic name etc : H3B-6545
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational materia
Sponsors
Eisai Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Subject 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 >=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: a) two prior hormonal therapies, or b) one prior hormonal therapy and one prior chemotherapy regimen, or c) one prior hormonal therapy and a CDK4/6 inhibitor. 4. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 5. Subject has adequate bone marrow and organ function. 6. Subjects who are expected to survive for 3 months or longer after starting administration of the investigational drug. 7. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
Exclusion criteria
Exclusion criteria: 1. Subject with inflammatory breast cancer. 2. Subject is currently receiving or has received systemic corticosteroids =220 msec, QRS interval >109 msec, or QTcF >450 msec. h. Systolic blood pressure (BP) not deemed clinically controlled by the investigator. 4. Subject has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug. 5. Known to be human immunodeficiency virus (HIV) positive. 6. Active viral hepatitis (B or C) as demonstrated by positive serology. Subjects with chronic HBV infection is on antiviral therapy is eligible. 7. Any adverse event related to previous therapies for breast cancer that has not resolved to =<Grade 1 (with exception of the alopecia). 8. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [beta-hCG] or human chorionic gonadotropin [hCG] test). 9. Women of childbearing potential who don't agree that both the subject and her partner will use a medically effective method for contraception (as below) throughout the entire study period or for 28 days after study drug discontinuation. If a subject is on oral contraceptives, they should also be using some additional method. 10. Alcohol dependency within 6 months before study entry. 11. Subject has a concurrent malignancy or malignancy within 3 years of enrollment, with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer, or curatively resected cervical cancer. 12. Diagnosed with meningeal carcinomatosis. 13. Subjects with brain or subdural metastases. 14. Subject has a known intolerability to any oral antihistamine drug (only for Antihistamine Prophylactic Administration Part and Randomization Part). 15. Subject needs to receive systemic or topical usage of either antihistamine or corticosteroid during Cycle 1 (only for Randomization Part). 16. Subject has initiated to receive drugs may cause rash 7 days prior to starting study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety DLT, AE | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics pharmacodynamics pharmacogenomics PK | — |
Countries
Japan
Outcome results
None listed