RecruitingPhase 2NCT05035836

A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC)


Sponsor

M.D. Anderson Cancer Center

Enrollment

20 participants

Start Date

Nov 16, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 2, single-site, single-arm open-label trial of zanidatamab in patients with early stage, low risk HER2+ BC. The primary objective is to determine the efficacy of zanidatamab for patients with early stage HER2/neu positive (HER2+) breast cancer (BC) as determined by pathologic complete response (pCR) .


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a targeted antibody drug called zanidatamab (ZW25) in patients with early-stage HER2-positive breast cancer — a type of breast cancer driven by a protein called HER2 — before surgery. **You may be eligible if...** - You are over 18 with HER2-positive breast cancer - Your tumor is between 1 cm and 3 cm and has not spread to lymph nodes or elsewhere - You have not had any previous treatment for this breast cancer - Your heart function is normal - You are willing to have surgery after the study treatment **You may NOT be eligible if...** - Your tumor is larger than 3 cm or has spread - You have already received treatment for this current breast cancer - You have significant heart disease (heart failure, recent heart attack, uncontrolled high blood pressure) - You have HIV, active hepatitis B or C - You are pregnant or breastfeeding - You have had a major surgery in the past 4 weeks - You have a history of severe allergic reactions to antibody drugs - You require high-dose steroids or immune-suppressing drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZanidatamab

Given IV

DRUGLetrozole

Given by PO

DRUGTamoxifen

Given by PO


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT05035836


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