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Trial of Retifanlimab With Trastuzumab and Pertuzumab Combination in HER2-Addicted Breast Cancer

NCT07772245 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-19

No results posted yet for this study

Summary

The goal of this Clinical Trial is to find out how well 3 medicines (retifanlimab, trastuzumab and pertuzumab) work at treating HER2-positive breast cancer in Male and female patients, 18 or older. The main question aims to determine the pathologic response rate \[residual cancer burden (RCB)- 0\] in the breast and lymph nodes after 6 cycles of retifanlimab, trastuzumab and pertuzumab in patients with HER2-addicted breast cancer. Participants will will have at least 6 cycles of the study drug, assuming the participant is responding to and tolerating the treatment well. Every cycle will last about 21 days.

Conditions

  • HER2-addicted Breast Cancer

Interventions

DRUG

Retifanlimab

375 mg administered as an IV infusion over 30 minutes Q3W.

DRUG

Trastuzumab (Herceptin)

Loading dose as 8 mg/kg IV infusion over 90 minutes; Subsequent doses as 6 mg/kg IV infusion over 30-90 minutes Q3W

DRUG

Pertuzumab

Loading dose as 840 mg IV infusion over 60 minutes; Subsequent doses as 420 mg IV infusion over 30-60 minutes Q3W

Sponsors & Collaborators

  • Polly A. Niravath, MD

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2029-12-31
Completion
2032-12-31
FDA Drug
Yes

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07772245 on ClinicalTrials.gov