American Institute of Research | Innovative Clinical Research Institute
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
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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