A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)

• Status: Active, not recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug. It has not yet been approved for use. DS-8201a may slow down tumor growth. This might improve outcomes for these patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo, Inc.
• Collaborators: AstraZeneca; Daiichi Sankyo Co., Ltd.
• Treatments: Ado-trastuzumab emtansine

Criteria

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

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 corrected QT interval (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