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

  • End date
    Sep 7, 2024
  • participants needed
  • sponsor
    Daiichi Sankyo, Inc.
Updated on 7 October 2020
Principal Investigator
Primary Contact
Macquarie University Hospital (1.3 mi away) Contact
+69 other location
adjuvant therapy
her2/neu-positive breast cancer


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


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.

Treatment Capecitabine, Trastuzumab, Lapatinib, Trastuzumab deruxtecan
Clinical Study IdentifierNCT03523585
SponsorDaiichi Sankyo, Inc.
Last Modified on7 October 2020

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Breast Cancer?
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
7 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males)
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. Prior treatment in the adjuvant/neo-adjuvant setting would be allowed if progression of disease did not occur within 12 months of end of adjuvant therapy
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
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Step 2 Get screened

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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