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

Status: Active


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

Eligibility Criteria

Inclusion Criteria

  • Is the age of majority in their country
  • Has pathologically documented breast cancer that:
  • is unresectable or metastatic
  • has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
  • was previously treated with ado-trastuzumab emtansine (T-DM1)
  • Has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy)
  • Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, agrees to provide a fresh biopsy.
  • Male and female participants of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least:
  • 4.5 months after the last dose of DS-8201a
  • 6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants)
  • 7 months after the last dose of trastuzumab/capecitabine
  • Has adequate hematopoietic, renal and hepatic functions

Exclusion Criteria

  • Has previously participated in an antibody drug conjugate study sponsored by Daiichi Sankyo
  • Has had prior treatment with capecitabine
  • Has uncontrolled or significant cardiovascular disease
  • Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
  • Has active central nervous system (CNS) metastases

Locations & Contacts

District of Columbia

MedStar Washington Hospital Center
Status: Active
Name Not Available


University of Maryland / Greenebaum Cancer Center
Status: Active
Contact: Nancy S. Tait
Phone: 410-328-3546
Email: ntait@umm.edu


Beth Israel Deaconess Medical Center
Status: Active
Name Not Available
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available


Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available


Case Comprehensive Cancer Center
Status: In review
Name Not Available
Ohio State University Comprehensive Cancer Center
Status: Approved
Name Not Available


M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase III

Trial Type


Lead Organization

Lead Organization
Daiichi Sankyo, Inc.

Trial IDs

Primary ID DS8201-A-U301
Secondary IDs NCI-2018-03422, 2018-000221-31
Clinicaltrials.gov ID NCT03523585