NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031210364

Registered date:02/10/2021

ONO-4578-06:Phase I study of ONO-4578 and letrozole plus CDK4 /6 inhibitors in breast cancer

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedbreast cancer
Date of first enrollment09/11/2021
Target sample size40
Countries of recruitment
Study typeInterventional
Intervention(s)ONO-4578 is co-administered with the standard treatment letrozole and a CDK4 / 6 inhibitor.

Outcome(s)

Primary OutcomeSafety and tolerability
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderFemale
Include criteria1. Patients with postmenopausal metastatic or recurrent breast cancer 2. Patients with ECOG Performance Status 0 to 1 3. ER-positive, PgR-positive and HER2-negative patients
Exclude criteria1.Patients are unable to swallow oral medications 2.Patients with severe complication

Related Information

Contact

Public contact
Name Center Information Medical
Address 3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka 618-8585, Japan Osaka Japan 618-8585
Telephone +81-120626190
E-mail clinical_trial@ono-pharma.com
Affiliation Ono Pharmaceutical Co.,LTD
Scientific contact
Name Masahiro Osawa
Address 3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka 618-8585, Japan Osaka Japan 618-8585
Telephone +81-120626190
E-mail clinical_trial@ono-pharma.com
Affiliation Ono Pharmaceutical Co.,LTD