DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

Official Title

A Phase 2, Multicentre, Open-Label Study of DS-8201a, an Anti-HER2-Antibody Drug Conjugate (ADC) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1

Summary:

Some HER-2 breast cancer patients do not respond or build resistance 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 tumour growth. This might improve outcomes for these patients.

Trial Description

Primary Outcome:

• Objective response rate (ORR) per imaging assessment

• Duration of response
• Best percent change in the sum of the longest diameters (SLD) of measurable tumours
• Disease control rate (DCR)
• Clinical benefit rate (CBR)
• Progression-free survival
• Overall survival (OS)
• ORR assessed by the investigator based on RECIST version 1.1
• Maximum plasma/serum concentration (Cmax)
• Time to Cmax (Tmax)
• Area under the concentration-time curve (AUC) from dosing until the last quantifiable concentration (AUClast)
• AUC from the time of dosing until day 21 (AUC0-21d)

View this trial on ClinicalTrials.gov