Zanidatamab for Early Stage HER2+ Breast Cancer

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 Phase 2 Interventional Study
Breast Cancer HER2-positive
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
M.D. Anderson Cancer Center · Other
Who this trial is looking for

This trial is looking for patients with early stage HER2-positive breast cancer. Participants will receive the drug zanidatamab and may undergo surgery if needed.

Are You a Good Fit for This Trial?
Rules you out PregnancyHIVActive Hepatitis BActive Hepatitis C

You may be able to join if

  • I am over 18 years old.
  • I can give written consent.
  • I am willing to have surgery if needed.
  • I have a tumor size between 1 cm and 3 cm.
  • I have been diagnosed with HER2-positive breast cancer.
  • I have normal organ and bone marrow function.
  • I agree to avoid pregnancy or use effective birth control.
  • I have a negative pregnancy test if I could become pregnant.

You may not be able to join if

  • I am currently pregnant or breastfeeding.
  • I have had a major surgery within the last 4 weeks.
  • I have a significant heart condition.
  • I have uncontrolled high blood pressure.
  • I have an active infection or other uncontrolled illness.
  • I have a history of life-threatening allergic reactions to similar drugs.
  • I have known HIV or active hepatitis.
  • I have received previous treatment for breast cancer.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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) .

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Ability to give written informed consent 2. Age \> 18 years at time of study entry. 3. Patient would be willing to undergo surgery is appropriate for surgery 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 1). 5. Tumor size \> 1 cm to ≤ 3 c…
Contacts

Vicente Valero

713-563-0751

vvalero@mdanderson.org

CONTACT