51
Participants
Start Date
June 23, 2017
Primary Completion Date
March 31, 2021
Study Completion Date
February 20, 2023
Interferon-gamma (IFN-γ)
Phase 1: IFN-γ 50 or 75 mcg/m\^2 SQ x 3 days/week for 12 weeks. Phase 2: IFN-γ at Recommended Phase II Dose (RP2D) subcutaneously (SQ) x 3 days/week, for 12 weeks.
Paclitaxel
Phase 1 and Phase 2: Paclitaxel 80 mg/m\^2/week, for 12 weeks.
Trastuzumab
Phase 1 and Phase 2: Trastuzumab 8 mg/kg intravenous (IV) loading dose on cycle 1/day 1 (C1D1), followed by 6 mg/kg on subsequent cycles every 3 weeks, for 12 weeks.
Pertuzumab
Phase 1 and Phase 2: Pertuzumab 840 mg IV loading dose on C1D1, followed by 420 mg on subsequent cycles every 3 weeks, for 12 weeks.
Post Therapy Surgery
Phase 2: Participants will be assessed for surgery following the fourth cycle of study therapy (or earlier if study treatment is cancelled due to unmanageable side effects).
H. Lee Moffitt Cancer Center and Research Institute, Tampa
Horizon Pharma Ireland, Ltd., Dublin Ireland
INDUSTRY
H. Lee Moffitt Cancer Center and Research Institute
OTHER