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Clinical Trial Summary

The study is designed to compare DS 8201a versus standard of care (investigator's choice) in subjects with unresectable and/or metastatic breast cancer previously treated with T DM1.


Clinical Trial Description

Primary Objective:

- To compare the progression-free survival (PFS) benefit of DS 8201a to investigator's choice.

Secondary Objectives:

- To further investigate the efficacy of DS 8201a compared to investigator's choice on:

1. Overall survival (OS);

2. Objective response rate (ORR);

3. Duration of response (DoR);

4. Clinical benefit rate (CBR).

- To further determine pharmacokinetics (PK) of DS 8201a.

- To further evaluate safety of DS 8201a compared to investigator's choice.

- To evaluate Health Economics and Outcomes Research (HEOR) endpoints for DS 8201a compared to investigator's choice. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03523585
Study type Interventional
Source Daiichi Sankyo, Inc.
Contact (For Sites in Asia Only) Daiichi Sankyo Contact for Clinical Tri
Phone +81-3-6225-1111(M-F 9-5 JST)
Email dsclinicaltrial@daiichisankyo.co.jp
Status Not yet recruiting
Phase Phase 3
Start date August 2018
Completion date February 2022

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