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New drug zanidatamab aims to shrink early breast cancer tumors before surgery

NCT ID NCT05035836

First seen Oct 31, 2025 · Last updated Jun 23, 2026 · Updated 32 times

Summary

This phase 2 trial is testing a drug called zanidatamab in 20 people with early-stage, low-risk HER2-positive breast cancer. The drug is given intravenously, along with hormone therapy pills (letrozole or tamoxifen). The main goal is to see if the cancer disappears completely by the time of surgery. The study is currently recruiting at a single site.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • M D Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

zanidatamab (also called ZW25), given intravenously, along with letrozole or tamoxifen pills

What this could lead to

If it works, this could point toward a new treatment option for early-stage HER2+ breast cancer that may reduce the need for chemotherapy.

What could go wrong

This is a very small, early-phase trial with only 20 participants and no comparison group. The drug may not work as hoped, and side effects are still being studied.

Conditions

The condition(s) this trial relates to.

breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.