Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT05035836

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

Led by M.D. Anderson Cancer Center · Updated on 2025-12-22

20

Participants Needed

1

Research Sites

371 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

Z

Zymeworks BC Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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) .

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to give written informed consent
  • Age over 18 years at time of study entry
  • Willingness to undergo surgery if appropriate
  • ECOG performance status of 0 or 1
  • Tumor size greater than 1 cm to 3 cm by ultrasound; clinically and radiographically node negative with no metastatic disease
  • HER2-positive breast cancer as defined by ASCO-CAP guidelines; ER positive or negative
  • Normal left ventricular ejection fraction by echocardiogram or MUGA scan within 4 weeks prior to first dose
  • Adequate organ and marrow function including hemoglobin ≥ 9.0 g/dL, ANC ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L
  • Serum bilirubin ≤ 1.5 x institutional upper limit of normal (≤ 2.5 x ULN for Gilbert's disease)
  • AST and ALT ≤ 3 x institutional upper limit of normal
  • Calculated glomerular filtration rate > 50 mL/min
  • Non-reproductive potential or agreement to use contraception during study and for 12 months after treatment
  • Negative pregnancy test within 3 days prior to first dose of zanidatamab
Not Eligible

You will not qualify if you...

  • Involvement in planning or conduct of the study
  • Prior or concurrent malignancy that could interfere with safety or efficacy assessment
  • Previous therapy for current breast cancer diagnosis including investigational therapy, endocrine therapy, targeted therapy, chemotherapy, surgery, or radiation
  • QTc interval ≥ 470 ms
  • Uncontrolled illness including active infection, active peptic ulcer or gastritis, bleeding disorders, or psychiatric illness/social situations limiting compliance
  • Pregnant, breastfeeding, or reproductive potential without effective birth control
  • Uncontrolled seizures
  • Major surgery within 4 weeks prior to enrollment (except portacath placement)
  • Significant cardiac disease such as ventricular arrhythmia requiring therapy, recent myocardial infarction, unstable angina, history of heart failure, or uncontrolled hypertension
  • Known active Hepatitis B or C infection
  • Known HIV positive status
  • Lifetime anthracycline dose exceeding 360 mg/m2 doxorubicin or equivalent
  • Need for systemic corticosteroids (>10 mg prednisone daily) or immunosuppressive medication within 14 days prior to randomization (with some exceptions)
  • History of life-threatening hypersensitivity to monoclonal antibodies or drug components
  • Known distant metastatic disease including CNS metastases
  • Acute or chronic uncontrolled renal, pancreatic, or liver disease (except Gilbert's syndrome, asymptomatic gallstones, stable chronic liver disease)
  • Symptomatic pulmonary embolism within 28 days
  • Administration of live vaccine within 4 weeks prior to randomization (COVID vaccines that are not live allowed with 48-hour gap before study drug)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

V

Vicente Valero

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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