Trial ID:NCT03523585
Protocol #:18-500
Condition(s):Breast Cancer
Phase:III
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