Last updated on July 2018

Phase 2 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

Brief description of study

The primary objective of this study is to investigate the effect of 5 mg KHK2375 on progression free survival (PFS) when administered orally at weekly intervals in combination with exemestane in a placebo-controlled, double-blind comparative study in subjects with advanced or recurrent hormone receptor-positive breast cancer. The secondary objectives are to investigate the effect of on overall survival (OS) and the antitumor effect and to evaluate the pharmacokinetics and safety.

Clinical Study Identifier: NCT03291886

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Kyowa Hakko Kirin Co., Ltd.

The Cancer Institute Hospital of JFCR
Koto, Japan

Kyowa Hakko Kirin Co., Ltd.

National Cancer Center Hospital
Chuo, Japan

Kyowa Hakko Kirin Co., Ltd.

Toranomon Hospital
Minato, Japan

Kyowa Hakko Kirin Co., Ltd.

Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital
Bunkyo, Japan

Kyowa Hakko Kirin Co., Ltd.

Showa University Hospital
Shinagawa, Japan

Kyowa Hakko Kirin Co., Ltd.

Gunma Cancer Center
Ota, Japan

Recruitment Status: Closed

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