臨床研究等提出・公開システム

Phase 2 study of DS-8201a in subjects with breast cancer

DESTINY-Breast01

Inoguchi Akihiro

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

dsclinicaltrial@daiichisankyo.co.jp

Contact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

completed

Aug. 30, 2017

Interventional

Multicenter, open-label, phase 2 study

treatment purpose

2

1. Men or women the age of majority in their country
2. Has pathologically documented breast cancer that:
is unresectable or metastatic
has HER2 positive expression confirmed per protocol
3. Has an adequate tumor sample
4. Has at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
5. Has protocol-defined adequate cardiac, renal and hepatic function
6. Agrees to follow protocol-defined method(s) of contraception

1. Has a medical history of myocardial infarction, symptomatic CHF (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
2. Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females
3. Has a medical history of clinically significant lung disease

Both

HER2 positive unresectable and/or metastatic breast cancer subjects who are resistant or refractory to T-DM1

investigational material(s)
Generic name etc : DS-8201a
INN of investigational material : trastuzumab deruxtecan
Therapeutic category code : 42- Antineoplastic agents
Dosage and Administration for Investigational material : Intravenous

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

efficacy
Objective response rate (ORR)
assessment by independent central imaging facility
review based on RECIST version 1.1.

safety
efficacy
pharmacokinetics
Duration of response, best percent change in the sum of the longest diameters of measurable tumors, disease control rate, clinical benefit rate, progression free survival, overall survival, ORR assessed by the investigator based on RECIST version 1.1, Pharmacokinetics, safety

July. 11, 2017