Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug cocktail aims to outsmart advanced breast cancer

NCT ID NCT04538742

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study is testing the safety and effectiveness of combining trastuzumab deruxtecan (T-DXd) with other cancer drugs for people with HER2-positive metastatic breast cancer. About 245 participants will receive different drug combinations to find the best doses and see if the tumors shrink or stop growing. The goal is to improve treatment options for this advanced form of breast cancer.

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 (T-DXd) combined with other anti-cancer drugs (durvalumab, paclitaxel, pertuzumab, tucatinib)
What this could lead to
If successful, this could point toward more effective combination treatments for HER2-positive metastatic breast cancer, potentially improving how long the disease is controlled.
What could go wrong
This is an early-phase trial (Phase 1b/2) with a small number of participants, so results may not apply to all patients. Combining drugs also raises the risk of side effects, and the study is not designed to prove a cure.

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

245 people

The number who actually took part.

Started

Dec 2020

Expected to finish

Jan 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.

Key Inclusion Criteria: * Patients must be at least 18 years of age * Pathologically documented breast cancer that: 1. Is advanced/unresectable (patients that can be treated with curative intent are not eligible) or metastatic 2. HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local assessment. The local HER2 result must be from a tumour sample obtained in the metastatic setting. 3. Is documented as hormone receptor-positive (estrogen or progesterone receptor) or negative in the metastatic setting * Patient must have adequate tumor sample from the metastatic setting for biomarker assessment * ECOG Performance Status of 0 or 1 * Part 1 1. Disease progression on or after the last systemic therapy prior to starting study treatment 2. At least 1 prior treatment line in metastatic setting required. * Part 2 (Modules 0 - 5) a) No prior lines of therapy for advanced/MBC allowed * Part 2 (Module 6 and 7) a) Zero or one prior lines of therapy for advanced/MBC allowed CNS Inclusion * Modules 0 - 5 Patients must have no brain metastases or stable brain metastases. * Module 6 and 7 Patients must have untreated brain metastases not needing local therapy or previously treated brain metastases that have progressed since prior local therapy Key Exclusion Criteria: * Uncontrolled or significant cardiovascular disease * Active or prior documented (non-infectious) ILD/pneumonitis that required steroids, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening * Lung-specific intercurrent clinically significant illnesses * Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals * Spinal cord compression or a history of leptomeningeal carcinomatosis * Prior treatment with immune checkpoint inhibitors * Prior treatment with an ADC containing a topoisomerase I inhibitor * Prior treatment with tucatinib CNS Exclusion * Modules 0 - 5: Has untreated brain metastasis * Module 6 and 7: Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of \> 2 mg dexamethasone or any brain lesion thought to require immediate local therapy

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for HER2-positive metastatic breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

brain cancer breast cancer breast carcinoma breast neoplasm HER2 positive 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

    Fort Myers, Florida, 33901, United States

  • Research Site

    St. Petersburg, Florida, 33705, United States

  • Research Site

    Commack, New York, 11725, United States

  • Research Site

    Harrison, New York, 10604, United States

  • Research Site

    New York, New York, 10016, United States

  • Research Site

    New York, New York, 10065, United States

  • Research Site

    Columbus, Ohio, 43219, United States

  • Research Site

    Nashville, Tennessee, 37203, United States

  • Research Site

    Fort Worth, Texas, 76104, United States

  • Research Site

    Fairfax, Virginia, 22031, United States

  • Research Site

    Melbourne, 3000, Australia

  • Research Site

    Barretos, 14784-400, Brazil

  • Research Site

    Belo Horizonte, 30150-274, Brazil

  • Research Site

    Natal, 59075-740, Brazil

  • Research Site

    Porto Alegre, 90610-000, Brazil

  • Research Site

    Porto Alegre, 91350-200, Brazil

  • Research Site

    Rio de Janeiro, 20560-120, Brazil

  • Research Site

    São Paulo, 01317-001, Brazil

  • Research Site

    São Paulo, 04029-000, Brazil

  • Research Site

    Sorocaba, 18030-005, Brazil

  • Research Site

    Montreal, Quebec, H2X 0A9, Canada

  • Research Site

    Québec, Quebec, G1S 4L8, Canada

  • Research Site

    Toronto, M5G 2M9, Canada

  • Research Site

    Villejuif, 94805, France

  • Research Site

    München, 81675, Germany

  • Research Site

    Würzburg, 97080, Germany

  • Research Site

    Delhi, 110085, India

  • Research Site

    Gurgaon, 122001, India

  • Research Site

    Madurai, 625107, India

  • Research Site

    Mumbai, 400012, India

  • Research Site

    Bologna, 40138, Italy

  • Research Site

    Milan, 20141, Italy

  • Research Site

    Naples, 80131, Italy

  • Research Site

    Rome, 168, Italy

  • Research Site

    Bydgoszcz, 85-796, Poland

  • Research Site

    Koszalin, 75-581, Poland

  • Research Site

    Lodz, 90-242, Poland

  • Research Site

    Lublin, 20-090, Poland

  • Research Site

    Moscow, 105229, Russia

  • Research Site

    Moscow, 109240, Russia

  • Research Site

    Moscow, 111123, Russia

  • Research Site

    Moscow, 115478, Russia

  • Research Site

    Moscow, 117997, Russia

  • Research Site

    Moscow, 121205, Russia

  • Research Site

    Moscow, 143423, Russia

  • Research Site

    Saint Petersburg, 195271, Russia

  • Research Site

    Saint Petersburg, 196603, Russia

  • Research Site

    Saint Petersburg, 197758, Russia

  • Research Site

    Busan, 602-739, South Korea

  • Research Site

    Seoul, 02841, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Barcelona, 08003, Spain

  • Research Site

    L'Hospitalet de Llobregat, 08908, Spain

  • Research Site

    Madrid, 28007, Spain

  • Research Site

    Madrid, 28050, Spain

  • Research Site

    Seville, 41013, Spain

  • Research Site

    Hualien City, 970, Taiwan

  • Research Site

    Tainan, 704, Taiwan

  • Research Site

    Taipei, 10048, Taiwan

  • Research Site

    Taipei, 10449, Taiwan

  • Research Site

    Taipei, 11217, Taiwan

  • Research Site

    Taipei, 114, Taiwan

  • Research Site

    Taipei, 235, Taiwan

  • Research Site

    Taoyuan City, 333, Taiwan

  • Research Site

    Ankara, 6100, Turkey (Türkiye)

  • Research Site

    Edirne, 22030, Turkey (Türkiye)

  • Research Site

    Istanbul, 34662, Turkey (Türkiye)

  • Research Site

    Istanbul, 34722, Turkey (Türkiye)

  • Research Site

    Izmir, 35100, Turkey (Türkiye)

  • Research Site

    Buckhurst Hill, IG9 5HX, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.