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Phase 2 Zanidatamab for Early Stage HER2-Positive Breast Cancer

This study is testing a drug called zanidatamab in women with early-stage HER2-positive (HER2+) breast cancer. HER2+ means the cancer cells have too much of a protein called HER2, which can make them grow faster. You might also receive letrozole or tamoxifen, which are hormone therapies. Researchers want to see how well zanidatamab works by measuring the pathologic complete response (pCR), which means no signs of cancer are found in the breast and lymph nodes after treatment. They are also looking at safety and other ways the tumor responds. To join, you must be over 18, willing to have surgery if needed, and have a tumor between 1 cm and 3 cm that has not spread.

Study design
This is a Phase 2, single-arm, open-label study, meaning all 20 participants will receive zanidatamab, and both you and your doctors will know which treatment you are getting.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint (pCR) is measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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)

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~20 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:ZanidatamabLetrozoleTamoxifen

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over through study completion, an average of 1 year

Conditions

Breast Cancer
HER2-positive

Explore related trials

Breast CarcinomaERBB2 Gene

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Vicente Valero · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Vicente Valero
[email protected]
713-563-0751
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Hemoglobin ≥ 9.0 g/dL
Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (≥ 1500 per mm3)
Platelet count ≥ 100 x 109/L (≥100,000 per mm3)
Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). The maximum allowable bilirubin is ≤ 2.5 x ULN for patients with Gilbert's disease.
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN
Calculated glomerular filtration rate \>50 mL/min 9. Patients must either be of non-reproductive potential or willing to undergo appropriate contraception. Male subjects must agree not to donate sperm and female subjects must agree not to donate oocytes starting at screening and throughout the study period, and for at least 12 months after treatment discontinuation. 10. Patient with reproductive potential must have a negative pregnancy test ≤3 days prior to the first dose of zanidatamab.

What this trial measures

  • To determine the efficacy of zanidatamab for patients with early stage HER2/neu positive (HER2+) breast cancer (BC) as determined by pathologic complete response (pCRthrough study completion, an average of 1 year