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Clinical trial

DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

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Last updated:1st Aug 2018
Identifier: NCT03523585

Brief 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

Detailed Description:
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.

Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T-DM1
Actual Study Start Date: August 1, 2018
Estimated Primary Completion Date: February 2022
Estimated Study Completion Date: February 2022

- Experimental:
Trastuzumab deruxtecan (DS-8201a)
- Active Comparator: Trastuzumab+capecitabine
- Active Comparator: Lapatinib+capecitabine

Category Value
Date last updated at source 2019-07-16
Study type(s) Interventional
Expected enrolment 600
Study start date 2018-08-01
Estimated primary completion date 2022-02-01

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