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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. (DESTINY-Breast02)

Not Enrolling

Trial ID:NCT03523585

View complete trial on

Protocol #:18-500

877-DF-TRIAL (877-338-7425)

Condition(s):Breast Cancer


Principal Investigator:Waks, Adrienne

Site Investigator(s):Desai, Neelam,

Site Research Nurse(s):Campbell, Margaret,
Caradonna, Lisa,
Carrier, Amy,
Huff, Kimberly,
Kasparian, Elizabeth,
Livesey, Megan,
O'Neil, Kelly,
Roche, Kathleen, A.
Rutter, Morgan,

Trial Description:
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 Requirements:
- Is the age of majority in their country
- Has pathologically documented breast cancer that:
1. is unresectable or metastatic
2. has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
3. 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:
1. 7 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males)
2. 6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants)
3. 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

Protocol #: 18-500

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