Trustees of The University of Pennsylvania | Abramson Cancer Center
Status and phase
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Study type
Funder types
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About
This study will compare DS 8201a to standard treatment.
Participants must have HER2 breast cancer that has been treated before.
Their cancer:
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Is the age of majority in their country
Has pathologically documented breast cancer that:
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:
Has adequate hematopoietic, renal and hepatic functions
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
608 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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