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Trial Summary

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.

Acronym:

Daiichi

ACTRN/NCT /ethics:

NCT03523585

Scientific 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 Pretreated With Prior Standard of Care HER2 Therapies, Including T-DM1

Sponsor / Cooperative group:

Daiichi Sankyo, Inc.

Trial & Patient Characteristics

Cancer TypeBreast
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexBoth
Tumour Stream -
Cancer StageLocally Recurrent or Locally Advanced, Metastatic or Widespread
Anticipated Start Date2018-08-01
Anticipated End Date2022-02-01

Participating Hospitals

HospitalAshford Cancer Centre Research
Clinical Trial CoordinatorSue Yeend
Emailsyeend@adelaidecancercentre.com.au
Phone08 8292 2240
Principal InvestigatorDr Meena Okera
Recruitment StatusRecruiting
HospitalCalvary North Adelaide Hospital
Clinical Trial CoordinatorJulie Rowe
Emailjulie.rowe@calvarycare.org.au
Phone08 8239 9536
Principal InvestigatorDr Sid Selva
Recruitment StatusRecruiting