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New hope for advanced breast cancer: targeted drug combo tested in major trial

NCT ID NCT04784715

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Updated 2 times

Summary

This study tests a new drug called trastuzumab deruxtecan (T-DXd), given alone or with another drug (pertuzumab), against the current standard treatment for HER2-positive breast cancer that has spread. About 1,157 people with this type of cancer will take part. The goal is to see if the new approach keeps the cancer from growing longer and is safe.

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

1,157 people

The number who actually took part.

Started

Apr 2021

Expected to finish

Dec 2029

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.

Key Inclusion Criteria: * Patients must be ≥18 years of age * Pathologically documented breast cancer that: 1. is advanced or metastatic 2. is locally assessed and prospectively centrally confirmed as HER2-positive (IHC3+ or ISH+) 3. is documented by local testing as hormone receptor (HR)-positive or HR-negative disease in the metastatic setting * No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer or only 1 previous line of endocrine therapy in the metastatic setting. Participants who have received chemotherapy or HER2-targeted therapy in the neo-adjuvant or adjuvant setting are eligible if \> 6 months from treatment to metastatic diagnosis. * Has protocol-defined adequate organ and bone marrow function * ECOG performance status 0 or 1 Key Exclusion Criteria: * Ineligible for any of the agents on the study. * Any substance abuse or other medical conditions that, in the investigator's opinion, may interfere with subject's participation or study results * Patients with spinal cord compression or clinically active central nervous system metastases. Participants with clinically inactive brain metastases or treated brain metastases that are no longer symptomatic may be included in the study. * Active or prior documented interstitial lung disease (ILD)/pneumonitis or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening * Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment

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Conditions

The condition(s) this trial relates to.

breast disorder breast neoplasm HER2 positive breast carcinoma Neoplasm Metastasis

As listed by the trial registrant

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

Breast cancer; HER2-positive; metastatic

Contacts and locations

Locations

  • Research Site

    Shirley, New York, 11967, United States

  • Research Site

    York, Pennsylvania, 17403, United States

  • Research Site

    Germantown, Tennessee, 38138, United States

  • Research Site

    Dallas, Texas, 75203, United States

  • Research Site

    Dallas, Texas, 75246, United States

  • Research Site

    Denton, Texas, 76201, United States

  • Research Site

    Houston, Texas, 77090, United States

  • Research Site

    San Antonio, Texas, 78240, United States

  • Research Site

    Shenandoah, Texas, 77380, United States

  • Research Site

    Tyler, Texas, 75702, United States

  • Research Site

    Norfolk, Virginia, 23502, United States

  • Research Site

    Roanoke, Virginia, 24014, United States

  • Research Site

    Tacoma, Washington, 98405, United States

  • Research Site

    Buenos Aires, C1125ABD, Argentina

  • Research Site

    CABA, 1414, Argentina

  • Research Site

    CABA, C1012AAR, Argentina

  • Research Site

    Caba, C1118AAT, Argentina

  • Research Site

    Capital Federal, C1417DTB, Argentina

  • Research Site

    Cipolletti, 8234, Argentina

  • Research Site

    Ciudad de Buenos Aires, 1280, Argentina

  • Research Site

    La Plata, 1900, Argentina

  • Research Site

    Mar del Plata, 7600, Argentina

  • Research Site

    Rosario, S2000DEJ, Argentina

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    Rosario, S2002KDS, Argentina

  • Research Site

    San Salvador de Jujuy, 4600, Argentina

  • Research Site

    Brussels, 1160, Belgium

  • Research Site

    Brussels, 1200, Belgium

  • Research Site

    Charleroi, 6060, Belgium

  • Research Site

    Edegem, 2650, Belgium

  • Research Site

    Ghent, 9000, Belgium

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Liège, 4000, Belgium

  • Research Site

    Namur, 5000, Belgium

  • Research Site

    Florianópolis, 88034-000, Brazil

  • Research Site

    Goiânia, 74000-000, Brazil

  • Research Site

    Londrina, 86015-520, Brazil

  • Research Site

    Natal, 59075-740, Brazil

  • Research Site

    Porto Alegre, 90035-003, Brazil

  • Research Site

    Ribeirão Preto, 14015-130, Brazil

  • Research Site

    São Paulo, 03102-002, Brazil

  • Research Site

    Sorocaba, 18030-005, Brazil

  • Research Site

    Vitória, 29043-260, Brazil

  • Research Site

    Calgary, Alberta, T2N 5G2, Canada

  • Research Site

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Research Site

    Barrie, Ontario, L4M 6M2, Canada

  • Research Site

    Kitchener, Ontario, N2G 1G3, Canada

  • Research Site

    Newmarket, Ontario, L3Y 2P9, Canada

  • Research Site

    North York, Ontario, M2K 1E1, Canada

  • Research Site

    Toronto, Ontario, M5G 1X5, Canada

  • Research Site

    Montreal, Quebec, H1T 2M4, Canada

  • Research Site

    Montreal, Quebec, H2X 3E4, Canada

  • Research Site

    Montreal, Quebec, H3T 1M5, Canada

  • Research Site

    Montreal, Quebec, H4A 3J1, Canada

  • Research Site

    Ste-Foy, Quebec, G1V 4G2, Canada

  • Research Site

    Saskatoon, Saskatchewan, S7N 4H4, Canada

  • Research Site

    Beijing, 100039, China

  • Research Site

    Beijing, 100044, China

  • Research Site

    Beijing, 100191, China

  • Research Site

    Changchun, 130021, China

  • Research Site

    Changsha, 410008, China

  • Research Site

    Changsha, 410013, China

  • Research Site

    Chengdu, 610041, China

  • Research Site

    Chongqing, 400016, China

  • Research Site

    Chongqing, 400030, China

  • Research Site

    Dalian, 116011, China

  • Research Site

    Guangzhou, 510060, China

  • Research Site

    Guangzhou, 510080, China

  • Research Site

    Guangzhou, 510120, China

  • Research Site

    Hangzhou, 310003, China

  • Research Site

    Hangzhou, 310022, China

  • Research Site

    Harbin, 150049, China

  • Research Site

    Kunming, 650118, China

  • Research Site

    Nanchang, 330009, China

  • Research Site

    Nanjing, 210008, China

  • Research Site

    Nanjing, 210029, China

  • Research Site

    Nanning, 530021, China

  • Research Site

    Qingdao, 266100, China

  • Research Site

    Shanghai, 200025, China

  • Research Site

    Shanghai, 200032, China

  • Research Site

    Shenyang, 110001, China

  • Research Site

    Shenzhen, 518036, China

  • Research Site

    Tianjin, 300060, China

  • Research Site

    Wuhan, 430022, China

  • Research Site

    Wuhan, 430030, China

  • Research Site

    Wuhan, 430060, China

  • Research Site

    Xi'an, 710004, China

  • Research Site

    Xi'an, 710061, China

  • Research Site

    Yinchuan, 750004, China

  • Research Site

    Zhengzhou, 450008, China

  • Research Site

    Copenhagen O, 2100, Denmark

  • Research Site

    Sønderborg, 6400, Denmark

  • Research Site

    Vejle, 7100, Denmark

  • Research Site

    Avignon, 84000, France

  • Research Site

    Besançon, 25000, France

  • Research Site

    Bordeaux, 33030, France

  • Research Site

    Caen, 14076, France

  • Research Site

    Le Mans, 72000, France

  • Research Site

    Montpellier, 34070, France

  • Research Site

    Montpellier, 34298, France

  • Research Site

    Nice, 06189, France

  • Research Site

    Paris, 75005, France

  • Research Site

    Pierre-Bénite, 69495, France

  • Research Site

    Rennes, 35042, France

  • Research Site

    Saint-Cloud, 92210, France

  • Research Site

    Saint-Herblain, 44805, France

  • Research Site

    Toulouse, 31059, France

  • Research Site

    Vandœuvre-lès-Nancy, 54519, France

  • Research Site

    Berlin, 10117, Germany

  • Research Site

    Dresden, 1307, Germany

  • Research Site

    Erlangen, 91054, Germany

  • Research Site

    Essen, 45136, Germany

  • Research Site

    Frankfurt am Main, 60431, Germany

  • Research Site

    Freiburg im Breisgau, 79110, Germany

  • Research Site

    Hamburg, 20357, Germany

  • Research Site

    Heidelberg, 69120, Germany

  • Research Site

    Leipzig, 04103, Germany

  • Research Site

    Münster, 48149, Germany

  • Research Site

    Paderborn, 33161, Germany

  • Research Site

    Budapest, 1062, Hungary

  • Research Site

    Budapest, 1082, Hungary

  • Research Site

    Budapest, 1115, Hungary

  • Research Site

    Budapest, 1122, Hungary

  • Research Site

    Budapest, 1145, Hungary

  • Research Site

    Győr, 9024, Hungary

  • Research Site

    Kecskemét, 6000, Hungary

  • Research Site

    Nyíregyháza, 4400, Hungary

  • Research Site

    Szolnok, 5000, Hungary

  • Research Site

    Ahmedabad, 380060, India

  • Research Site

    Bangalore, 560027, India

  • Research Site

    Bengaluru, 560099, India

  • Research Site

    Calicut, 673601, India

  • Research Site

    Gurgaon, 122001, India

  • Research Site

    Mysuru, 570017, India

  • Research Site

    Nashik, 422009, India

  • Research Site

    Nashik, 422011, India

  • Research Site

    New Delhi, 110075, India

  • Research Site

    New Delhi, 110085, India

  • Research Site

    Haifa, 31096, Israel

  • Research Site

    Jerusalem, 9112001, Israel

  • Research Site

    Petah Tikva, 4941492, Israel

  • Research Site

    Ramat Gan, 5266202, Israel

  • Research Site

    Tel Aviv, 64239, Israel

  • Research Site

    Bergamo, 24127, Italy

  • Research Site

    Candiolo, 10060, Italy

  • Research Site

    Genova, 16132, Italy

  • Research Site

    Livorno, 57100, Italy

  • Research Site

    Milan, 20141, Italy

  • Research Site

    Naples, 80131, Italy

  • Research Site

    Padova, 35128, Italy

  • Research Site

    Rozzano, 20089, Italy

  • Research Site

    Udine, 33100, Italy

  • Research Site

    Akashi-shi, 673-8558, Japan

  • Research Site

    Aomori, 030-8553, Japan

  • Research Site

    Bunkyō City, 113-8431, Japan

  • Research Site

    Chiba, 260-8717, Japan

  • Research Site

    Chūōku, 104-0045, Japan

  • Research Site

    Fukushima, 960-1295, Japan

  • Research Site

    Hidaka-shi, 350-1298, Japan

  • Research Site

    Hiroshima, 730-8518, Japan

  • Research Site

    Hiroshima, 734-8551, Japan

  • Research Site

    Isehara-shi, 259-1193, Japan

  • Research Site

    Kagoshima, 892-0833, Japan

  • Research Site

    Kawasaki-shi, 216-8511, Japan

  • Research Site

    Kobe, 650-0047, Japan

  • Research Site

    Kōtoku, 135-8550, Japan

  • Research Site

    Kurume-shi, 830-0011, Japan

  • Research Site

    Kyoto, 606-8507, Japan

  • Research Site

    Matsuyama, 791-0280, Japan

  • Research Site

    Nagoya, 464-8681, Japan

  • Research Site

    Nagoya, 467-8602, Japan

  • Research Site

    Niigata, 951-8566, Japan

  • Research Site

    Nishinomiya-shi, 663-8501, Japan

  • Research Site

    Okayama, 700-8558, Japan

  • Research Site

    Osaka, 541-8567, Japan

  • Research Site

    Ota-shi, 373-8550, Japan

  • Research Site

    Sapporo, 003-0804, Japan

  • Research Site

    Sendai, 980-8574, Japan

  • Research Site

    Shinagawa-ku, 142-8666, Japan

  • Research Site

    Shinjuku-ku, 160-0023, Japan

  • Research Site

    Shinjuku-ku, 162-8655, Japan

  • Research Site

    Shizuoka, 420-8527, Japan

  • Research Site

    Tsu, 514-8507, Japan

  • Research Site

    Yokohama, 241-8515, Japan

  • Research Site

    Alc. Cuauhtémoc, 06700, Mexico

  • Research Site

    Estado de México, 50080, Mexico

  • Research Site

    Guadalajara, 44680, Mexico

  • Research Site

    Metepec, 52140, Mexico

  • Research Site

    Nuevo León, 66278, Mexico

  • Research Site

    Veracruz, 91910, Mexico

  • Research Site

    Arequipa, AREQUIPA01, Peru

  • Research Site

    Lima, 15033, Peru

  • Research Site

    Lima, 15036, Peru

  • Research Site

    Lima, LIMA 29, Peru

  • Research Site

    Lima, LIMA 34, Peru

  • Research Site

    Baguio City, 2600, Philippines

  • Research Site

    Cebu City, 6000, Philippines

  • Research Site

    Davao City, 8000, Philippines

  • Research Site

    Iloilo City, 5000, Philippines

  • Research Site

    Manila, 1000, Philippines

  • Research Site

    Quezon City, 1112, Philippines

  • Research Site

    San Juan City, 1500, Philippines

  • Research Site

    Bucharest, 011461, Romania

  • Research Site

    Floreşti, 407280, Romania

  • Research Site

    Moscow, 121205, Russia

  • Research Site

    Moscow, 129090, Russia

  • Research Site

    Moscow, 143442, Russia

  • Research Site

    Saint Petersburg, 190020, Russia

  • Research Site

    Saint Petersburg, 197758, Russia

  • Research Site

    Yaroslavl, 150054, Russia

  • Research Site

    Dammam, 31444, Saudi Arabia

  • Research Site

    Jeddah, 22384, Saudi Arabia

  • Research Site

    Jeddah, 23214, Saudi Arabia

  • Research Site

    Riyadh, 11211, Saudi Arabia

  • Research Site

    Riyadh, 11426, Saudi Arabia

  • Research Site

    Cape Town, 7570, South Africa

  • Research Site

    Cape Town, 7925, South Africa

  • Research Site

    George, 6529, South Africa

  • Research Site

    Johannesburg, 2193, South Africa

  • Research Site

    Johannesburg, 2196, South Africa

  • Research Site

    Port Elizabeth, 6045, South Africa

  • Research Site

    Pretoria, 0081, South Africa

  • Research Site

    Rondebosch, 7700, South Africa

  • Research Site

    Soweto, 2013, South Africa

  • Research Site

    Cheonan-si, 31151, South Korea

  • Research Site

    Daegu, 41404, South Korea

  • Research Site

    Goyang-si, 10408, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 06273, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Seoul, 06591, South Korea

  • Research Site

    Seoul, 08308, South Korea

  • Research Site

    Alicante, 03010, Spain

  • Research Site

    Barcelona, 08028, Spain

  • Research Site

    Barcelona, 08036, Spain

  • Research Site

    Barcelona, 8035, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Madrid, 28046, Spain

  • Research Site

    Majadahonda, 28222, Spain

  • Research Site

    Seville, 41009, Spain

  • Research Site

    Gothenburg, 413 45, Sweden

  • Research Site

    Örebro, 701 85, Sweden

  • Research Site

    Stockholm, 118 83, Sweden

  • Research Site

    Uppsala, 75185, Sweden

  • Research Site

    Vaxjo, 35185, Sweden

  • Research Site

    Taichung, 40443, Taiwan

  • Research Site

    Tainan, 70403, Taiwan

  • Research Site

    Taipei, 100, Taiwan

  • Research Site

    Taipei, 10449, Taiwan

  • Research Site

    Taipei, 11217, Taiwan

  • Research Site

    Taipei, 235, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

  • Research Site

    Adana, 01330, Turkey (Türkiye)

  • Research Site

    Ankara, 06520, Turkey (Türkiye)

  • Research Site

    Ankara, 06800, Turkey (Türkiye)

  • Research Site

    Cordaleo, 35575, Turkey (Türkiye)

  • Research Site

    Malatya, 44280, Turkey (Türkiye)

  • Research Site

    Samsun, 55200, Turkey (Türkiye)

  • Research Site

    Edinburgh, EH4 2XU, United Kingdom

  • Research Site

    Guildford, GU2 7WG, United Kingdom

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    London, EC1A 7BE, United Kingdom

  • Research Site

    London, NW1 2PG, United Kingdom

  • Research Site

    Manchester, M20 4BX, United Kingdom

  • Research Site

    Swansea, SA2 8QA, United Kingdom

  • Research Site

    Taunton, TA1 5DA, United Kingdom

  • Research Site

    Tucson, Arizona, 85711, United States

  • Research Site

    Springdale, Arkansas, 72762, United States

  • Research Site

    Glendale, California, 91204, United States

  • Research Site

    Glendale, California, 91206, United States

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    Longmont, Colorado, 80501, United States

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    Miami, Florida, 33176, United States

  • Research Site

    Palm Bay, Florida, 32909, United States

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    Plantation, Florida, 33324, United States

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    Atlanta, Georgia, 30318, United States

  • Research Site

    Louisville, Kentucky, 40241, United States

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    Silver Spring, Maryland, 20904, United States

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    Boston, Massachusetts, 02215, United States

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    Detroit, Michigan, 48202, United States

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    Jackson, Mississippi, 39213, United States

  • Research Site

    Las Vegas, Nevada, 89128, United States

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    Summit, New Jersey, 07901, United States

  • Research Site

    New York, New York, 10065, United States