Phase 1 study of KHK2375 in subjects with advanced or recurrent breast cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223012

Enrollment

Registered

2015-11-12

Start date

2015-11-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or recurrent breast cancer

Interventions

investigational material(s) Generic name etc : KHK2375 INN of investigational material : entinostat Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: - Postmenopausal women aged >= 20 and < 75 years at the time of consent; - Estrogen receptor positive and/or progesterone receptors positive; - HER2-negative - Nonresectable advanced or recurrent breast cancer previously treated with nonsteroidal aromatase inhibitor (AI), and planning to be treated with exemestane

Exclusion criteria

Exclusion criteria: - Radiation therapy or immuno therapy within 14 days before the first dose of investigational product; - Chemotherapy, biological medicines, other pharmacotherapy or major surgery within 21 days before the first dose of the investigational product; - Prior chemotherapies of ≥ 3 regimens for advanced or recurrent breast cancer; - Ongoing treatment with other investigational product

Design outcomes

Primary

Measure	Time frame
safety Safety	—

Secondary

Measure	Time frame
efficacy pharmacokinetics Pharmacokinetics and efficacy	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026