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New hope for hard-to-treat breast cancer: drug targets HER2-low tumors

NCT ID NCT05831878

Disease control Sponsor: RenJi Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests a drug called Disitamab vedotin (RC48-ADC) in 36 people with HER2-low advanced breast cancer that cannot be cured. Participants have had only one prior chemotherapy. The goal is to see if the drug can shrink tumors and how safe it is. This is an early study, so results are not yet known.

What this could mean

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

Active substance
Disitamab vedotin (RC48-ADC)
What this could lead to
If it works, this could offer a new treatment option for people with HER2-low advanced breast cancer who have few alternatives.
What could go wrong
This is a small, early-phase trial with only 36 participants, so results may not apply broadly. The drug may cause side effects or fail to shrink tumors.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 36 people

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

Started

May 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Female patients aged ≥18 years * Expected survival ≥12 weeks * ECOG 0-1 * Histologically confirmed invasive advanced or metastatic breast cancer that is incurable and unresectable * At least one measurable lesion according to the RECIST 1.1 * No history of antibody-drug conjugate use * Up to one previous chemotherapy for advanced disease * Available hormone receptor status. Hormone receptor-positive subjects are allowed to receive no more than two previous endocrine therapy for advanced disease * HER2-low tumors, defined as IHC1+ or IHC2+ with negative FISH test; or HER2-ultralow tumors, defined as incomplete and faint membrane staining in \>0 but ≤10% of tumor cells * Adequate organ function Exclusion Criteria: * History of thromboembolic events * Uncontrolled systemic diseases, including diabetes, hypertension, interstitial lung disease, cirrhosis, etc. * Active infections requiring systemic treatment * Pregnant or lactating * Presence of brain metastases and/or carcinomatous meningitis

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Conditions

The condition(s) this trial relates to.

breast cancer

As listed by the trial registrant

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

Advanced breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Renji Hospital, School of Medicine, Shanghai Jiaotong University

    RECRUITING

    Shanghai, 200127, China

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