Status and phase
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About
This study will compare DS-8201a to physician choice standard treatment.
Participants must have HER2-low breast cancer that has been treated before.
Participants' cancer:
Full description
This is a randomized, 2-arm, Phase 3, open-label, multicenter study to compare the safety and efficacy of trastuzumab deruxtecan versus the physician's choice (2:1) in HER2-low, unresectable and/or metastatic breast cancer participants.
The Sponsor proposes to define a new HER2-low population in this trial including tumors with IHC 1+ and IHC 2+/ISH- HER2 expression.
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)
Has adequate archival tumor samples available or is wiling to provide fresh biopsies prior to randomization for:
Has at least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors 1.1
Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
Male and female participants of reproductive/childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels)
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
557 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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