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Can adding brain radiation boost a targeted drug against HER2-Positive breast cancer?

NCT ID NCT07100600

Disease control Sponsor: Henan Cancer Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 13, 2026 · Last updated Oct 14, 2026 · Updated 1 time

Summary

Researchers are testing whether combining brain radiation with trastuzumab rezetecan works better than the drug alone in women with HER2-positive advanced breast cancer that has spread to the brain. About 224 participants will be randomly assigned to receive either the drug plus radiation or the drug by itself. The trial measures how long participants live without their cancer worsening, along with brain tumor response and side effects.

What this could mean

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

Active substance
trastuzumab rezetecan, an antibody-drug combination that targets HER2, given with or without brain radiation
What this could lead to
If adding radiation helps, it could offer a way to control breast cancer that has spread to the brain and delay worsening of brain lesions.
What could go wrong
This is a mid-stage trial, so the combination may not work better than the drug alone, and radiation to the brain carries risks such as swelling, fatigue, and cognitive effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 224 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Females ≥18 yrs old; 2. Pathologically confirmed HER2-positive advanced breast cancer; 3. At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment; 4. Without prior cranial radiation and had no indication for immediate local treatment or refuse to local treatment; 5. Life expectancy is not less than 6 months. 6. Adequate function of major organs. Exclusion Criteria: 1. Subjects with leptomeningeal metastasis 2. CNS complications requiring emergency neurosurgical intervention 3. Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor; 4. Suffering from heart disease that is not well controlled or having clinical symptoms 5. History of clinically significant lung disease； 6. Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years. 7. Female subjects during pregnancy and lactation 8. Any other conditions that researchers believe that patients are unsuitable for this study.

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Conditions

The condition(s) this trial relates to.

brain cancer HER2 positive breast carcinoma metastatic malignant neoplasm in the brain

As listed by the trial registrant

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

Brain metastases HER2-positive advanced breast cancer Radiotherapy

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Professor

    RECRUITING

    Zhengzhou, Henan, China

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