Phase I-II Study of Interferon-gamma in Patients With HER-2 Positive Breast Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

June 23, 2017

Primary Completion Date

March 31, 2021

Study Completion Date

February 20, 2023

Conditions
Breast CancerBreast Cancer, MaleBreast Cancer FemaleHER2-positive Breast Cancer
Interventions
BIOLOGICAL

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.

DRUG

Paclitaxel

Phase 1 and Phase 2: Paclitaxel 80 mg/m\^2/week, for 12 weeks.

DRUG

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.

OTHER

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.

PROCEDURE

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).

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

All Listed Sponsors
collaborator

Horizon Pharma Ireland, Ltd., Dublin Ireland

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT03112590 - Phase I-II Study of Interferon-gamma in Patients With HER-2 Positive Breast Cancer | Biotech Hunter | Biotech Hunter