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 |
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Health condition(s) or Problem(s) studied | breast cancer |
Date of first enrollment | 09/11/2021 |
Target sample size | 40 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | ONO-4578 is co-administered with the standard treatment letrozole and a CDK4 / 6 inhibitor. |
Outcome(s)
Primary Outcome | Safety and tolerability |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Female |
Include criteria | 1. 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 criteria | 1.Patients are unable to swallow oral medications 2.Patients with severe complication |
Related Information
Primary Sponsor | Osawa Masahiro |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
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 |
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 |
clinical_trial@ono-pharma.com | |
Affiliation | Ono Pharmaceutical Co.,LTD |