Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

This study will compare DS 8201a to standard treatment.

Participants must have HER2 breast cancer that has been treated before.

Their cancer:

  • cannot be removed by an operation
  • has spread to other parts of the body

Official Title

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1

Details

The study is designed to compare DS 8201a versus standard of care (investigator's choice) in subjects with unresectable and/or metastatic breast cancer previously treated with T-DM1.

Keywords

Breast Cancer, Metastatic breast cancer, DS 8201a, DESTINY - Breast 02, Breast Neoplasms, Capecitabine, Trastuzumab, Lapatinib, Trastuzumab deruxtecan, Trastuzumab deruxtecan (DS-8201a), Trastuzumab+capecitabine, Lapatinib+capecitabine

Eligibility

Locations

  • UCLA Hematology Oncology - Main Site
    Los Angeles California 90095 United States
  • Sharp Memorial Hospital
    San Diego California 92123 United States
  • Innovative Clinical Research Institute
    Whittier California 90603 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Daiichi Sankyo
ID
NCT03523585
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 608 people participating
Last Updated