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New hope for aggressive breast cancer: targeted drug combo shows promise in early trial

NCT ID NCT06797635

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This phase 2 trial is testing whether adding a targeted drug called patritumab deruxtecan to standard immunotherapy and chemotherapy can improve outcomes for people with high-risk early-stage triple-negative or hormone receptor-low positive breast cancer. About 372 participants will receive different combinations of these drugs before surgery, and researchers will check how many have no cancer cells left after surgery. The study also monitors safety 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
Patritumab deruxtecan (a targeted antibody-drug conjugate) plus pembrolizumab (an immunotherapy) and chemotherapy (carboplatin, paclitaxel, doxorubicin)
What this could lead to
If successful, this could lead to a more effective treatment before surgery for high-risk early-stage breast cancer, potentially increasing the chance of eliminating all cancer cells.
What could go wrong
This is an early phase 2 trial with a small number of participants, so results may not apply to everyone. The combination of drugs can cause serious side effects, including lung inflammation and immune-related reactions.

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 372 people

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

Started

Mar 2025

Expected to finish

Dec 2034

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 locally advanced, non-metastatic (M0), breast cancer, defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee on Cancer (AJCC) criteria: cT1c, N1-N2; cT2, N0-N2; cT3, N0-N2; or cT4a-d, N0-N2 * Has centrally confirmed diagnosis of breast cancer that is triple-negative or HR-low+/HER2- breast cancer that will be treated according to the triple-negative breast cancer (TNBC) paradigm * Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load * Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 28 days prior to allocation/randomization * Has left ventricular ejection fraction (LVEF) of ≥50% or ≥ lower limit of normal (LLN) as assessed by echocardiogram (ECHO) or multigate acquisition scan (MUGA) scan Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has uncontrolled or significant cardiovascular disease before randomization * Has any history of or evidence of any current leptomeningeal carcinomatosis. * Has clinically significant corneal disease * Has human immunodeficiency virus (HIV) infection with a history of Kaposi sarcoma and/or multicentric Castleman disease * Has evidence of ongoing, uncontrolled, systemic bacterial, fungal, or viral infection * Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor * Has received any prior treatment, including radiation, systemic therapy, and/or definitive surgery for currently diagnosed breast cancer * Has received prior treatment with an anti-human epidermal growth factor receptor 3 (HER3) antibody and/or antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan) * Has metastatic (Stage IV) breast cancer or cN3 nodal involvement * Has known additional malignancy that is progressing or has required active treatment within the past 5 years * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current or suspected ILD * Has an active infection requiring systemic therapy * Has concurrent active HBV and HCV infection * Has clinically severe respiratory compromise resulting from intercurrent pulmonary illness

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer triple-negative 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

    17 sites in 4 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 2401)

    RECRUITING

    Seoul, 05505, South Korea

  • Clinica Universidad de Navarra ( Site 1703)

    RECRUITING

    Madrid, Madrid, Comunidad de, 28027, Spain

  • Hospital Universitario Reina Sofia ( Site 1702)

    RECRUITING

    Córdoba, 14004, Spain

  • Houston Methodist Hospital ( Site 0022)

    RECRUITING

    Houston, Texas, 77030, United States

  • Institut Català d'Oncologia (ICO) - Badalona ( Site 1700)

    RECRUITING

    Badalona, Catalonia, 08916, Spain

  • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0003)

    RECRUITING

    Billings, Montana, 59102, United States

  • Koo Foundation Sun Yat-Sen Cancer Center ( Site 2501)

    RECRUITING

    Taipei, 112, Taiwan

  • National Cheng Kung University Hospital ( Site 2503)

    RECRUITING

    Tainan, 704, Taiwan

  • Northwest Cancer Specialists (Compass Oncology) ( Site 8003)

    RECRUITING

    Tigard, Oregon, 97223, United States

  • Orchard Healthcare Research Inc. ( Site 0006)

    RECRUITING

    Skokie, Illinois, 60077, United States

  • SCRI Oncology Partners ( Site 7000)

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Seoul National University Hospital ( Site 2400)

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System ( Site 2402)

    RECRUITING

    Seoul, 03722, South Korea

  • Taichung Veterans General Hospital ( Site 2502)

    RECRUITING

    Taichung, 407, Taiwan

  • Texas Oncology - DFW ( Site 8000)

    RECRUITING

    Dallas, Texas, 75246, United States

  • UCLA Hematology/Oncology - Parkside ( Site 0021)

    RECRUITING

    Santa Monica, California, 90404, United States

  • Virginia Oncology Associates (VOA) ( Site 8001)

    RECRUITING

    Norfolk, Virginia, 23502, United States

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