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New drug shows promise for Hard-to-Treat breast cancer

NCT ID NCT06686394

Disease control Sponsor: Merck Sharp & Dohme LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called patritumab deruxtecan in people with HER2-positive breast cancer that has spread or cannot be removed by surgery. The goal is to see if the drug can shrink tumors and how safe it is. About 81 adults will take part. This is not a cure, but aims to control the disease.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 81 people

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

Started

Feb 2025

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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

Anyone

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: The main inclusion criteria include but are not limited to the following: * Has histologically confirmed HER2+ locally advanced unresectable breast cancer or metastatic breast cancer * Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART) * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable hepatitis B virus (HBV) viral load before allocation * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 7 days before start of study intervention Arm 1: * Has received at least a minimum of 2 and a maximum of 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting * Had disease progression on or after any previous trastuzumab deruxtecan (T-DXd) treatment Arm 2: -Has received no more than 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting Arm 3: -Has received and had disease progression from T-DXd treatment in any setting and a maximum of 3 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting. T-DXd must be the most recent therapy received before enrollment. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Uncontrolled or significant cardiovascular disease * History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/interstitial lung disease * Has clinically severe respiratory compromise * Has any history of or evidence of any current leptomeningeal disease * Has clinically significant corneal disease * Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection * HIV infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Known additional malignancy that is progressing or has required active treatment within the past 3 years * Evidence of spinal cord compression or brain metastases * Has an active infection requiring systemic therapy * Concurrent active HBV and HCV infection * Has had major surgical procedure (excluding placement of vascular access) less than 28 days Arm 3 ONLY \- Has received prior treatment with tucatinib, lapatinib, or neratinib, or any investigational HER2-targeted tyrosine kinase inhibitors in the locally advanced or metastatic setting

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

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

Breast cancer Breast neoplasms

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    18 sites in 6 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Asan Medical Center ( Site 0031)

    RECRUITING

    Seoul, 05505, South Korea

  • Centre Hospitalier de l'Université de Montréal ( Site 0004)

    RECRUITING

    Montreal, Quebec, H2X 3E4, Canada

  • Dana-Farber Cancer Institute ( Site 0050)

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Inova Schar Cancer Institute ( Site 0051)

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Jewish General Hospital ( Site 0003)

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Kingston General Hospital ( Site 0061)

    RECRUITING

    Kingston, Ontario, K7L 2V7, Canada

  • Nagoya City University Hospital ( Site 0020)

    RECRUITING

    Nagoya, Aichi-ken, 467-8602, Japan

  • Princess Margaret Cancer Centre ( Site 0001)

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053)

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Rabin Medical Center ( Site 0012)

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus ( Site 0011)

    RECRUITING

    Haifa, 3109601, Israel

  • Rutgers Cancer Institute of New Jersey ( Site 0052)

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Seoul National University Hospital ( Site 0030)

    RECRUITING

    Seoul, 03080, South Korea

  • Sheba Medical Center ( Site 0010)

    RECRUITING

    Ramat Gan, 5265601, Israel

  • St Bartholomew s Hospital ( Site 0040)

    RECRUITING

    London, London, City of, EC1A 7BE, United Kingdom

  • The Beatson West of Scotland Cancer Centre ( Site 0043)

    RECRUITING

    Glasgow, Glasgow City, G12 0YN, United Kingdom

  • University College London Hospital ( Site 0041)

    RECRUITING

    London, Camden, NW1 2PG, United Kingdom

  • University of Colorado Anschutz Medical Campus ( Site 0057)

    RECRUITING

    Aurora, Colorado, 80045, United States

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