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Promising combo targets hard-to-treat breast cancer

NCT ID NCT04556773

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 04, 2026 · Updated 2 times

Summary

This study tests a drug called trastuzumab deruxtecan (T-DXd) combined with other anti-cancer medicines in people with metastatic HER2-low breast cancer. The goal is to find safe doses and see if the combination can shrink tumors or slow the cancer's growth. About 138 adults with this type of breast cancer will take part.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

138 people

The number who actually took part.

Started

Dec 2020

Expected to finish

Jun 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 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.

Key Inclusion Criteria: * Patients must be at least 18 years of age * Male or female patients who have pathologically documented breast cancer that: 1. Has a history of HER2-low expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) with a validated assay 2. Is documented as HR+ (either ER and/or PgR positive \[ER or PgR ≥1%\]) or ER and PgR negative (ER and PgR \<1%) per ASCO/CAP guidelines in the metastatic setting * Patient must have adequate tumor sample for biomarker assessment * ECOG Performance Status of 0 or 1 For patients with HR+ disease: Part 1: At least 1 prior treatment line of ET with or without a targeted therapy (such as CDK4/6, mTOR or PI3-K inhibitors), and at least 1 prior line of chemotherapy for MBC are required. Part 2: Only 1 prior treatment line of ET with or without a targeted therapy (such as CDK4/6, mTOR or PI3-K inhibitors) for MBC is allowed. No prior chemotherapy in the metastatic setting is allowed. Note there are no patients with HR+ disease in Part 2 of Modules 2 and 3. For patients with HR- disease: Part 1: At least 1 prior line of chemotherapy for MBC is required. Note there are no patients with HR- disease in Part 1 of Modules 4 and 5. Part 2: For Module 2, no prior lines of therapy for MBC are allowed, and for Modules 1 and 3, only 1 prior line of chemotherapy for MBC is allowed. Note there are no patients with HR- disease in Part 2 of Modules 4 and 5. Key Exclusion Criteria: * Uncontrolled intercurrent illness * Uncontrolled or siginificant cardiovascular disease * 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 * Has spinal cord compression or clinically active central nervous system metastases * Active primary immunodeficiency * Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals * Prior treatment with ADC that comprises of an exatecan derivative that is a topoisomerase I inhibitor.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm triple-negative breast carcinoma

As listed by the trial registrant

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

Metastatic breast cancer

Contacts and locations

Locations

  • Research Site

    Commack, New York, 11725, United States

  • Research Site

    Harrison, New York, 10604, United States

  • Research Site

    New York, New York, 10029, United States

  • Research Site

    New York, New York, 10065, United States

  • Research Site

    Uniondale, New York, 11553, United States

  • Research Site

    Chapel Hill, North Carolina, 27514, United States

  • Research Site

    Chattanooga, Tennessee, 37404, United States

  • Research Site

    Germantown, Tennessee, 38138, United States

  • Research Site

    Fort Worth, Texas, 76104, United States

  • Research Site

    Melbourne, 3000, Australia

  • Research Site

    Westmead, 2145, Australia

  • Research Site

    Edegem, 2650, Belgium

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Ottignies, 1340, Belgium

  • Research Site

    Goiânia, 74605-070, Brazil

  • Research Site

    Porto Alegre, 90035-003, Brazil

  • Research Site

    Porto Alegre, 90110-270, Brazil

  • Research Site

    São Paulo, 03102-002, Brazil

  • Research Site

    São Paulo, 04543-000, Brazil

  • Research Site

    Kelowna, British Columbia, V1Y 5L3, Canada

  • Research Site

    Québec, Quebec, G1J 1Z4, Canada

  • Research Site

    Villejuif, 94805, France

  • Research Site

    Monterrey, 64710, Mexico

  • Research Site

    Moscow, 115478, Russia

  • Research Site

    Moscow, 143442, Russia

  • Research Site

    Saint Petersburg, 199226, Russia

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Kaohsiung City, 82445, Taiwan

  • Research Site

    Taichung, 40443, Taiwan

  • Research Site

    Taipei, 100, Taiwan

  • Research Site

    Taipei, 11217, Taiwan

  • Research Site

    Taipei, 114, Taiwan

  • Research Site

    Taipei, 235, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

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