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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

Study Summary

This trial will test the use of interferon-gamma in combination with paclitaxel, trastuzumab, and pertuzumab to treat HER2-positive breast cancer. The trial will evaluate the safety and tolerability of the combination and also determine the optimal dose of interferon-gamma to use in future studies.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1: Recommended Phase 2 Dose (RP2D)

Phase 2: Pathologic Complete Response Rate (pCR)

Secondary outcome measures

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

~5380

Post Therapy Surgery

2017

Completed Phase 2

~60

Trastuzumab

2014

Completed Phase 4

~5190

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,441 Total Patients Enrolled

40 Trials studying Breast Cancer

5,729 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What indications are Interferon-gamma (IFN-γ) typically utilized to treat?

"Interferon-gamma (IFN-γ) is an efficacious remedy for metastatic bladder cancer, inflammatory breast cancer (IBC), and acquired immunodeficiency syndrome."

Answered by AI

What other experiments have been conducted to assess the efficacy of Interferon-gamma (IFN-γ)?

"Presently, there are 983 active trials exploring the effects of Interferon-gamma (IFN-γ), with 259 in their final phase. Seattle is hosting most of these experiments, yet 54396 locations across the globe are contributing to this research effort."

Answered by AI

What is the aggregate patient count for this experiment?

"This investigation is not presently enrolling new participants. It was initially posted on June 23rd, 2017 and last updated on November 2nd 2022. If you are searching for other research studies, 2616 clinical trials are currently recruiting patients with breast cancer and 983 investigations require Interferon-gamma (IFN-γ) involvement from volunteers."

Answered by AI

Are there any vacancies for participants in this research endeavor?

"This clinical trial is no longer open for enrollment. The study was first listed on June 23, 2017 and its last update occured on November 2, 2022. If you're searching for other medical studies related to breast cancer or Interferon-gamma (IFN-γ), there are currently 2616 and 983 trials respectively that remain active in recruitment."

Answered by AI

Recent research and studies

The Cancer JournalJournal

Current State of Cell Therapies for Breast Cancer

Gautam, Namrata, Kelly M. Elleson, Ganesan Ramamoorthi, and Brian J. Czerniecki. 2022. “Current State of Cell Therapies for Breast Cancer”. The Cancer Journal. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ppo.0000000000000607.

The Cancer JournalJournal

Current State of Cell Therapies for Breast Cancer

clinicaltrials.govStudy

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

2017. "Phase I-II Study of Interferon-gamma in Patients With HER-2 Positive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03112590.