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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5450