A Phase 2 study of DS-8201a for HER2-Positive breast cancer that has either spread and/or cannot be treated with surgery and is resistant or non-responsive to T-DM1 treatment.

Phase 1

• Conditions: nresectable/metastatic breast cancer with HER2 positive expression; MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000020826; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-004986-18-ES
• Lead Sponsor: Daiichi Sankyo Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-02
• Last Update Posted: 29 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

•Men or women the age of majority in their country
•Has pathologically documented breast cancer that:
1.is unresectable or metastatic
2.has HER2 positive expression confirmed per protocol
•Has an adequate tumor sample
•Has at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
•Has protocol-defined adequate cardiac, renal and hepatic function
•Agrees to follow protocol-defined method(s) of contraception
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 230
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23

Exclusion Criteria

•Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
•Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females
•Has a medical history of clinically significant lung disease
•Is suspected to have certain other protocol-defined diseases based on imaging at screening period
•Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:
1.safety or well-being of the participant or offspring
2.safety of study staff
3.analysis of results

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified