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New hope for advanced breast cancer: drug shows promise against brain tumors

NCT ID NCT04739761

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Updated 2 times

Summary

This study tests the drug trastuzumab deruxtecan in about 500 people with advanced HER2-positive breast cancer, some of whom also have brain metastases. The goal is to see how well the drug shrinks tumors and how long it keeps the cancer from growing. Participants receive the drug by IV infusion every three weeks.

What this could mean

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

Active substance
trastuzumab deruxtecan (a targeted antibody-drug combination)
What this could lead to
If successful, this could confirm trastuzumab deruxtecan as an effective treatment for advanced HER2-positive breast cancer, including in patients with brain metastases.
What could go wrong
This is an early-phase study (3b/4) and results may not confirm long-term benefit. Side effects can include lung inflammation, nausea, and low blood cell counts.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

506 people

The number who actually took part.

Started

Jun 2021

Expected to finish

May 2027

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 to 130 years

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: * Participants should have pathologically documented breast cancer that is: unresectable/advanced or metastatic; confirmed HER2-positive status expression as determined according to American Society of Clinical Oncology/College of American Pathologists guidelines * Participant must have either: no evidence of BM, or untreated BM on screening contrast brain magnetic resonance imaging/ computed tomography (MRI/CT) scan, not needing immediate local therapy or previously-treated stable or progressing BM * Participants with BMs must be neurologically stable * For participants requiring radiotherapy due to BMs, there should be an adequate washout period before day of first dosing: * ≥ 7 days since stereotactic radiosurgery or gamma knife * ≥ 21 days since whole brain radiotherapy * Eastern Cooperative Oncology Group performance status 0-1 * Previous breast cancer treatment: radiologic or objective evidence of disease progression on or after HER2 targeted therapies and no more than 2 lines/regimens of therapy in the metastatic setting * Participant with the following measurable: at least 1 lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter with CT or MRI and is suitable for accurate repeated measurements; or following Non-measurable diseases: Non-measurable, bone-only disease that can be assessed by CT or MRI or X-Ray. Lytic or mixed lytic bone lesions that can be assessed by CT or MRI or X-ray in the absence of measurable disease as defined above is acceptable; Participants with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible; and Non-measurable CNS disease (Cohort 2 only) * Adequate organ and bone marrow function within 14 days before the day of first dosing as defined in the protocol * Left ventricular ejection fraction ≥ 50% within 28 days before enrollment * Negative pregnancy test (serum) for women of childbearing potential Exclusion Criteria * Known or suspected leptomeningeal disease * Prior exposure to tucatinib treatment * Refractory nausea and vomiting, chronic gastrointestinal disease, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of T-DXd * History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence * Based on screening contrast brain MRI/CT scan, participants must not have any of the following: any untreated brain lesions \> 2.0 cm in size; ongoing use of systemic corticosteroids for control of symptoms of BMs; any brain lesion thought to require immediate local therapy; have poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to BMs not withstanding CNS-directed therapy * Has spinal cord compression * Known active hepatitis B or C infection, such as those with serologic evidence of viral infection within 28 days of Cycle 1 Day 1. Participants with past or resolved hepatitis B virus infection are eligible, if negative for hepatitis B surface antigen and positive for anti-hepatitis B core antigen * Participants positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA * Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals * Receipt of live, attenuated vaccine within 30 days prior to the first dose of T-DXd * Participants with a medical history of myocardial infarction within 6 months before screening, symptomatic congestive heart failure (New York Heart Association Class II to IV) * History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening * Lung-specific intercurrent clinically significant illnesses and any autoimmune, connective tissue or inflammatory disorders * Prior exposure, without adequate treatment washout period before the day of first dosing, to chloroquine/hydroxychloroquine: \< 14 days * Anticancer chemotherapy: immunotherapy (non-antibody-based therapy), retinoid therapy, hormonal therapy: \< 3 weeks * \< 6 weeks for nitrosoureas or mitomycin * Antibody-based anticancer therapy: \< 4 weeks * Any concurrent anticancer treatment. Concurrent use of hormonal therapy for noncancer- related conditions is allowed * Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline * Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation, radiation to the chest, or to more than 30% of the bone marrow within 4 weeks before the first dose of study intervention * Participants with prior exposure to immunosuppressive medication within 14 days prior to first study dose * Participants with a known hypersensitivity to study intervention or any of the excipients of the product or other monoclonal antibodies

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Conditions

The condition(s) this trial relates to.

brain cancer 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

Contacts and locations

Locations

  • Research Site

    Boston, Massachusetts, 02215, United States

  • Research Site

    Durham, North Carolina, 27710, United States

  • Research Site

    Adelaide, 5000, Australia

  • Research Site

    Auchenflower, 4066, Australia

  • Research Site

    Clayton, 3168, Australia

  • Research Site

    Heidelberg, 3084, Australia

  • Research Site

    St Leonards, 2065, Australia

  • Research Site

    Subiaco, 6008, Australia

  • Research Site

    Anderlecht, 1070, Belgium

  • Research Site

    Bruges, 8000, Belgium

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Liège, 4000, Belgium

  • Research Site

    Vancouver, British Columbia, V5Z 1H7, Canada

  • Research Site

    Toronto, Ontario, M4N 3M5, Canada

  • Research Site

    Copenhagen, 2100, Denmark

  • Research Site

    Herlev, 2730, Denmark

  • Research Site

    Odense C, 5000, Denmark

  • Research Site

    Helsinki, 00290, Finland

  • Research Site

    Tampere, FI-33521, Finland

  • Research Site

    Turku, 20520, Finland

  • Research Site

    Berlin, 13125, Germany

  • Research Site

    Dresden, 1307, Germany

  • Research Site

    Erlangen, 91054, Germany

  • Research Site

    Essen, 45136, Germany

  • Research Site

    Frankfurt, 60389, Germany

  • Research Site

    Hamburg, 20246, Germany

  • Research Site

    Hanover, 30625, Germany

  • Research Site

    Kiel, 24105, Germany

  • Research Site

    Mannheim, 68167, Germany

  • Research Site

    München, 80336, Germany

  • Research Site

    München, 80637, Germany

  • Research Site

    Münster, 48149, Germany

  • Research Site

    Tübingen, 72076, Germany

  • Research Site

    Cork, T12 DV56, Ireland

  • Research Site

    Dublin, 7, Ireland

  • Research Site

    Dublin, D04 Y8V0, Ireland

  • Research Site

    Ancona, 60122, Italy

  • Research Site

    Bergamo, 24127, Italy

  • Research Site

    Catania, 95126, Italy

  • Research Site

    Milan, 20132, Italy

  • Research Site

    Naples, 80131, Italy

  • Research Site

    Padova, 35128, Italy

  • Research Site

    Prato, 59100, Italy

  • Research Site

    Isehara, 259-1193, Japan

  • Research Site

    Kawasaki-shi, 216-8511, Japan

  • Research Site

    Sapporo, 003-0804, Japan

  • Research Site

    Shinagawa-ku, 142-8666, Japan

  • Research Site

    Yokohama, 241-8515, Japan

  • Research Site

    Maastricht, 6229 HX, Netherlands

  • Research Site

    The Hague, 2545 AA, Netherlands

  • Research Site

    Bergen, 5009, Norway

  • Research Site

    Oslo, 450, Norway

  • Research Site

    Oslo, N-0379, Norway

  • Research Site

    Gdansk, 80-214, Poland

  • Research Site

    Krakow, 31-501, Poland

  • Research Site

    Opole, 45-060, Poland

  • Research Site

    Warsaw, 02-781, Poland

  • Research Site

    Warsaw, 04-141, Poland

  • Research Site

    Lisbon, 1400-048, Portugal

  • Research Site

    Lisbon, 1649-035, Portugal

  • Research Site

    Porto, 4099-001, Portugal

  • Research Site

    Barcelona, 08036, Spain

  • Research Site

    Barcelona, 8035, Spain

  • Research Site

    Bilbao (Vizcaya), 48013, Spain

  • Research Site

    Granada, 18014, Spain

  • Research Site

    Madrid, 28005, Spain

  • Research Site

    Madrid, 28034, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Salamanca, 37007, Spain

  • Research Site

    Santander, 39008, Spain

  • Research Site

    Santiago de Compostela-Coruña, 15706, Spain

  • Research Site

    Seville, 41013, Spain

  • Research Site

    Valencia, 46009, Spain

  • Research Site

    Gothenburg, 413 45, Sweden

  • Research Site

    Lund, 221 85, Sweden

  • Research Site

    Uppsala, 751 85, Sweden

  • Research Site

    Basel, 4031, Switzerland

  • Research Site

    Bellinzona, CH-6500, Switzerland

  • Research Site

    Lausanne, 1011, Switzerland

  • Research Site

    Lucerne, 6000, Switzerland

  • Research Site

    Edinburgh, EH4 2XR, United Kingdom

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