DESTINY-Breast01

Phase 2

Completed

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

• Registration Number: JPRN-jRCT2080223637
• Lead Sponsor: DAIICHI SANKYO Co.,Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Objective response rate (ORR)<br>assessment by independent central imaging facility<br>review based on RECIST version 1.1.

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>pharmacokinetics<br>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