New drug shows promise for Hard-to-Treat breast cancer in major trial

NCT ID NCT04494425

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether the targeted drug trastuzumab deruxtecan (T-DXd) works better than standard chemotherapy for people with a specific type of advanced breast cancer called HER2-low, hormone receptor positive. The study includes 866 participants whose cancer has spread and no longer responds to hormone therapy. The main goal is to see how long the cancer stays under control with T-DXd compared to chemo.

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)
What this could lead to: If successful, this could offer a more effective targeted treatment option for patients with HER2-low breast cancer who have stopped responding to hormone therapy.
What could go wrong: This is a phase 3 trial, but results are not yet final. T-DXd may cause side effects like lung inflammation or low blood cell counts, and it may not improve survival for all patients.

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

866 people

The number who actually took part.

Started

Jul 2020

Expected to finish

Jun 2026

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 105 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. has a history of HER2-low or negative expression by local test, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested) 3. has HER2-low or HER2 IHC \>0 \<1+ expression as determined by the central laboratory result established on a tissue sample taken in the metastatic setting 4. was never previously HER2-positive 5. is documented HR+ disease in the metastatic setting. * No prior chemotherapy for advanced or metastatic breast cancer. * Has adequate tumor samples for assessment of HER2 status * Must have either: 1. disease progression within 6 months of starting first line metastatic treatment with an endocrine therapy combined with a CDK4/6 inhibitor or 2. disease progression on at least 2 previous lines of endocrine therapy with or without a targeted therapy in the metastatic setting. Of note with regards to the ≥2 lines of previous ET requirement: disease recurrence while on the first 24 months of starting adjuvant ET, will be considered a line of therapy; these patients will only require 1 line of ET in the metastatic setting. * Has protocol-defined adequate organ and bone marrow function Key Exclusion Criteria: * Ineligible for all options in the investigator's choice chemotherapy arm * Lung-specific intercurrent clinically significant illnesses * Uncontrolled or significant cardiovascular disease or infection * Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening. * Patients with spinal cord compression or clinically active central nervous system metastases * Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment * Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study during the follow up period of a prior interventional study (prescreening for this study while a patient is on treatment in another clinical study is acceptable)

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Advanced or metastatic breast cancer

Contacts and locations

Locations

Research Site

Scottsdale, Arizona, 85259, United States
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Springdale, Arkansas, 72762, United States
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Duarte, California, 91010, United States
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Los Angeles, California, 90017, United States
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Aurora, Colorado, 80045, United States
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Lakewood, Colorado, 80228, United States
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Washington D.C., District of Columbia, 20016, United States
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Jacksonville, Florida, 32224, United States
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Kansas City, Kansas, 66160, United States
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Louisville, Kentucky, 40202, United States
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Bethesda, Maryland, 20817, United States
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Boston, Massachusetts, 02114, United States
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Detroit, Michigan, 48202, United States
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Rochester, Minnesota, 55905, United States
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St Louis, Missouri, 63110, United States
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Summit, New Jersey, 07901, United States
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Westbury, New York, 11590, United States
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Columbus, Ohio, 43210, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Nashville, Tennessee, 37232, United States
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Austin, Texas, 78731, United States
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Dallas, Texas, 75246, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77090, United States
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Norfolk, Virginia, 23502, United States
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Seattle, Washington, 98104, United States
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Madison, Wisconsin, 53792-5666, United States
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Buenos Aires, C1125ABD, Argentina
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CABA, 1414, Argentina
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CABA, C1012AAR, Argentina
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CABA, C1019ABS, Argentina
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Ciudad de Buenos Aires, 1280, Argentina
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Córdoba, 5000, Argentina
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La Plata, 1900, Argentina
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Mar del Plata, 7600, Argentina
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Rosario, S2000DEJ, Argentina
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Rosario, S2002KDS, Argentina
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Adelaide, 5000, Australia
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Birtinya, 4575, Australia
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Darlinghurst, 2010, Australia
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Murdoch, 6150, Australia
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South Brisbane, 4101, Australia
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St Leonards, 2065, Australia
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Waratah, 2298, Australia
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Anderlecht, 1070, Belgium
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Brussels, 1200, Belgium
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Charleroi, 6060, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Namur, 5000, Belgium
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Roeselare, 8800, Belgium
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Sint-Niklaas, 9100, Belgium
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Barretos, 14784-400, Brazil
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Belo Horizonte, 30110-022, Brazil
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Natal, 59075-740, Brazil
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Porto Alegre, 90610-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Rio de Janeiro, 20560-120, Brazil
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São Paulo, 04038-034, Brazil
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São Paulo, 1323001, Brazil
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Sorocaba, 18030-510, Brazil
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Calgary, Alberta, T2N 5G2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Toronto, CA, M5G 2M9, Canada
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London, Ontario, N6A 5W9, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 1X5, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Baoding, 071000, China
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Beijing, 100006, China
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Beijing, 100044, China
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Changchun, 130021, China
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Changsha, 410008, China
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Changsha, 410013, China
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Dalian, 116001, China
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Foshan, 528000, China
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Fuzhou, 350011, China
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Guangzhou, 510060, China
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Guangzhou, 510080, China
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Guangzhou, 510120, China
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Hangzhou, 310003, China
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Hangzhou, 310020, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Hefei, 230001, China
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Jinan, 250001, China
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Linyi, 276000, China
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Nanchang, 330006, China
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Nanchang, 330009, China
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Nanjing, 210009, China
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Nanjing, 210029, China
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Nanning, 530021, China
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Shanghai, 200032, China
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Shenyang, 110015, China
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Tianjin, 300060, China
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Ürümqi, 830000, China
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Wuhan, 430079, China
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Xi'an, 710004, China
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Xi'an, 710061, China
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Zhengzhou, 450008, China
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Aalborg, 9000, Denmark
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Copenhagen Ø, 2100, Denmark
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Odense, 5000, Denmark
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Vejle, 7100, Denmark
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Avignon, 84918, France
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Besançon, 25000, France
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Bordeaux, 33000, France
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Brest, 29609, France
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Caen, 14076, France
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Dijon, 21079, France
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Le Mans, 72000, France
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Marseille, 13273, France
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Montpellier, 34298, France
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Nice, 06100, France
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Paris, 75005, France
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Pierre-Bénite, 69495, France
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Plerin SUR MER, 22190, France
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Rennes, 35000, France
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Saint-Cloud, 92210, France
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Saint-Herblain, 44805, France
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Tours, 37000, France
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Villejuif, 94805, France
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Berlin, 10117, Germany
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Dresden, 01307, Germany
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Freiburg im Breisgau, 79110, Germany
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Hanover, 30625, Germany
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München, 81675, Germany
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München, D-80336, Germany
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Münster, 48149, Germany
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Velbert, 42551, Germany
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Budapest, 1062, Hungary
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Budapest, 1122, Hungary
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Budapest, 1145, Hungary
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Győr, 9024, Hungary
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Kecskemét, 6000, Hungary
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Nyíregyháza, 4400, Hungary
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Szolnok, 5000, Hungary
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Tatabánya, 2800, Hungary
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Bengaluru, 560099, India
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Calicut, 673601, India
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Kolkata, 700160, India
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Marg Jaipur, 302004, India
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New Delhi, 110 085, India
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New Delhi, 110005, India
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New Delhi, 110017, India
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New Delhi, 110075, India
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Surat, 395002, India
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Thiruvananthapuram, 695011, India
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Haifa, 3109601, Israel
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Jerusalem, 9103102, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 44281, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 52621, Israel
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Tel Aviv, 64239, Israel
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Aviano, 33081, Italy
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Bergamo, 24127, Italy
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Candiolo, 10060, Italy
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Cona, 44124, Italy
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Genova, 16132, Italy
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Livorno, 57124, Italy
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Messina, 98158, Italy
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Milan, 20141, Italy
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Milan, 20132, Italy
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Naples, 80131, Italy
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Padova, 35128, Italy
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Parma, Italy
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Prato, 59100, Italy
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Tricase, Lecce, 73039, Italy
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Udine, 33100, Italy
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Akashi-shi, 673-8558, Japan
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Bunkyō City, 113-8431, Japan
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Chiba, 260-8717, Japan
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Chūōku, 104-0045, Japan
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Fukuoka, 811-1395, Japan
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Gifu, 501-1194, Japan
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Hidaka-shi, 350-1298, Japan
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Hiroshima, 730-8518, Japan
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Isehara, 259-1193, Japan
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Kagoshima, 892-0833, Japan
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Kashiwa, 277-8577, Japan
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Kawasaki-shi, 216-8511, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kōtoku, 135-8550, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 460-0001, Japan
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Naha, 901-0154, Japan
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Niigata, 951-8566, Japan
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Nishinomiya-shi, 663-8501, Japan
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Okayama, 700-8558, Japan
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Osaka, 541-8567, Japan
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Osakasayama-shi, 589-8511, Japan
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Sagamihara-shi, 252-0375, Japan
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Sapporo, 060-8648, Japan
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Shinagawa-ku, 142-8666, Japan
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Shinjuku-ku, 160-0023, Japan
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Shizuoka, 420-8527, Japan
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Tsu, 514-8507, Japan
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Yokohama, 241-8515, Japan
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Alc. Cuauhtémoc, 06700, Mexico
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Guadalajara Jalisco, 44280, Mexico
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Guadalajra, 44260, Mexico
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Mexico City, '14080, Mexico
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Mexico City, 0 3100, Mexico
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Mexico City, 6760, Mexico
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México, 04700, Mexico
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Monterrey, 64460, Mexico
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Nuevo León, 66278, Mexico
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Amsterdam, 1066 CX, Netherlands
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Breda, 4818 CK, Netherlands
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Hengelo, 7555 DL, Netherlands
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Leeuwarden, 8934 AD, Netherlands
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Rotterdam, 3015 GD, Netherlands
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Sittard-Geleen, 6162 BG, Netherlands
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Bydgoszcz, 85-796, Poland
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Koszalin, 75-581, Poland
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Krakow, 31-501, Poland
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Lodz, 90-302, Poland
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Rzeszów, 35-021, Poland
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Warsaw, 02-781, Poland
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Wroclaw, 53-413, Poland
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Lisbon, 1500-650, Portugal
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Lisbon, 1649-035, Portugal
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Lisbon, 1998-018, Portugal
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Krasnodar, 350040, Russia
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Moscow, 111123, Russia
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Moscow, 115478, Russia
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Moscow, 117997, Russia
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Moscow, 121205, Russia
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Saint Petersburg, 190103, Russia
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Saint Petersburg, 195271, Russia
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Saint Petersburg, 197758, Russia
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Yaroslavl, 150054, Russia
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Dammam, 31444, Saudi Arabia
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Jeddah, 21423, Saudi Arabia
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Jeddah, 23214, Saudi Arabia
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Riyadh, 11426, Saudi Arabia
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Riyadh, 11525, Saudi Arabia
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Riyadh, 12713, Saudi Arabia
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Bukit Merah, 169610, Singapore
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Singapore, 119074, Singapore
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Singapore, 258499, Singapore
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Singapore, 308433, Singapore
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Singapore, 329563, Singapore
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Daegu, 41404, South Korea
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Goyang-si, 10408, South Korea
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Incheon, 22332, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 02841, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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A Coruña, 15006, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Barcelona, 08907, Spain
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Córdoba, 14004, Spain
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El Palmar, 30120, Spain
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Madrid, 28005, Spain
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Madrid, 28007, Spain
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Madrid, 28046, Spain
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San Sebastián, 20014, Spain
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Seville, 41013, Spain
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Valencia, 46026, Spain
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Gothenburg, 413 45, Sweden
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Örebro, 701 85, Sweden
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Stockholm, 118 83, Sweden
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Uppsala, 751 85, Sweden
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Vaxjo, 35185, Sweden
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Taichung, 40447, Taiwan
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Tainan, 70403, Taiwan
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Tainan, 710, Taiwan
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Taipei, 10048, Taiwan
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Taipei, 10449, Taiwan
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Taipei, 11217, Taiwan
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Taipei, 235, Taiwan
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Taoyuan, 333, Taiwan
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Cambridge, CB2 0QQ, United Kingdom
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Cardiff, CF14 2TL, United Kingdom
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Edinburgh, EH4 2XR, United Kingdom
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Guildford, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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London, SE1 9RT, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Northwood, HA6 2RN, United Kingdom

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