This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0980 administered with taxane-based chemotherapy regimens utilized in patients with locally recurrent or metastatic breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Oral repeating dose
Intravenous repeating dose
Intravenous repeating dose
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Nashville, Tennessee, United States
Unnamed facility
Leuven, Belgium
Incidence and nature of dose-limiting toxicities (DLTs)
Time frame: Through Day 22
Incidence, nature, and severity of adverse events
Time frame: Through study completion, up to 1 year, or early discontinuation
Pharmacokinetic parameters of GDC-0980, paclitaxel and bevacizumab (including total exposure, maximum and minimum plasma concentration, time to maximum observed plasma concentration, plasma half-life)
Time frame: Through Day 22
Duration of response
Time frame: Assessed at periodic intervals until study completion, up to 1 year, or early discontinuation
Progression-free survival (PFS)
Time frame: Assessed at periodic intervals until study completion, up to 1 year, or early discontinuation
Objective tumor response
Time frame: Assessed at periodic intervals until study completion, up to 1 year, or early discontinuation
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