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Cytokine

Interferon-gamma (IFN-γ) for Breast Cancer

Phase 1 & 2
Waitlist Available
Led By (Hyo) Heather S. Han, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial is testing a combination of a lab-made protein (Interferon-gamma) and three cancer drugs (paclitaxel, trastuzumab, and pertuzumab) in people with HER2-positive breast cancer. The goal is to find the safest and most effective dose. Interferon-gamma helps the immune system, while the other drugs target and kill cancer cells. Trastuzumab and pertuzumab are well-established HER2-targeted monoclonal antibodies used in combination with paclitaxel for treating HER2-positive breast cancer.

Eligible Conditions
  • HER2-positive Breast Cancer
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1: Recommended Phase 2 Dose (RP2D)
Phase 2: Pathologic Complete Response Rate (pCR)
Secondary study objectives
Phase 2: Clinical Response
Phase 2: Progression Free Survival (PFS)/Number of Participants Who Progressed

Trial Design

1Treatment groups
Experimental Treatment
Group I: Combination TherapyExperimental Treatment5 Interventions
Phase 1: Participants with HER-2 positive metastatic breast cancer enrolled in groups of 3-6 or more; each group participant to be given the same dose and schedule of Interferon-gamma plus paclitaxel, trastuzumab, and pertuzumab. If group participants do not have bad side effects, the next group will be given a higher dose of Interferon-gamma. This will continue until the highest safe dose of Interferon-gamma is found. Once highest safe dose of Interferon-gamma is found, participants may be enrolled in Phase II. Phase 2: Approximately 31 participants with Stage 2-3 HER2 positive early stage breast cancer enrolled to receive therapy with Interferon-gamma plus paclitaxel, trastuzumab, and pertuzumab. Interferon-gamma given at dose found in the Phase 1. Phase 2: Post therapy surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Interferon-gamma (IFN-γ)
2017
Completed Phase 2
~60
Paclitaxel
2011
Completed Phase 4
~5810
Post Therapy Surgery
2017
Completed Phase 2
~60
Trastuzumab
2014
Completed Phase 4
~5190

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
558 Previous Clinical Trials
144,489 Total Patients Enrolled
41 Trials studying Breast Cancer
5,745 Patients Enrolled for Breast Cancer
Horizon Pharma Ireland, Ltd., Dublin IrelandIndustry Sponsor
30 Previous Clinical Trials
3,762 Total Patients Enrolled
(Hyo) Heather S. Han, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
~6 spots leftby Sep 2025
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