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ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer

CompletedPhase 1

Sponsor: Ono Pharmaceutical Co., Ltd.

Conditions: Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer

Interventions: ONO-4578, letrozole, Palbociclib, abemaciclib

Countries: Japan

This is a multicenter, open-label, non-controlled, phase I study to investigate the tolerability and safety of ONO-4578 used in combination with standard-of-care letrozole and a CDK4/6 inhibitor (palbociclib or Abemaciclib) as first-line endocrine therapy in postmenopausal patients with metastatic or recurrent hormone receptor-positive, HER2-negative breast cancer.

Eligibility overview

Sex: FEMALE

Age: 20 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion 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

Exclusion Criteria:

1. Patients are unable to swallow oral medications
2. Patients with severe complication

Locations (13)

Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Chiba, Chiba, Japan
Kashiwa-shi, Chiba, Japan
Kawasaki-shi, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Kyoto, Kyoto, Japan
Sendai, Miyagi, Japan
Osaka, Osaka, Japan
Shinden, Saitama, Japan
Chuo-ku, Tokyo, Japan
Koto-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan