New drug combo aims to wipe out aggressive breast cancer before surgery

NCT ID NCT05113251

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times

Summary

This phase 3 trial is testing whether the drug trastuzumab deruxtecan (T-DXd), alone or with other chemotherapy drugs, works better than standard treatment before surgery in people with high-risk HER2-positive early breast cancer. About 927 participants will receive one of three treatment plans before surgery. The main goal is to see if the cancer completely disappears by the time of surgery.

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, Enhertu) with or without paclitaxel, trastuzumab, pertuzumab, doxorubicin, and cyclophosphamide
What this could lead to: If successful, this could offer a more effective pre-surgery treatment option for high-risk HER2-positive early breast cancer, potentially leading to higher rates of complete tumor disappearance.
What could go wrong: This is an early-stage trial in a specific high-risk group, and results may not apply to all patients. Side effects from the drug combination, including heart or lung issues, are possible.

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

927 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Apr 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. * Histologically documented HER2-positive early breast cancer (EBC) participants, including clinical stage at presentation (based on mammogram or breast MRI assessment): T0-4 (inclusive of inflammatory breast cancer), N1-3, M0 or ≥ T3, N0, M0 as determined by the AJCC staging system, 8th edition * ECOG performance status of 0 or 1 at randomization * Adequate organ and bone marrow function * LVEF ≥ 50% within 28 days before randomization * FFPE tissue block (2 cores) or 20 freshly-cut, serial tumor slides for HER2 assessment by central lab. If blocks are incomplete or fewer than 20 slides are available, participants may be eligible following discussion with the AstraZeneca Study Physician Exclusion Criteria: * prior history of invasive breast cancer * stage IV breast cancer (determined by AJCC staging system) * any primary malignancy within 3 years (except resected non-melanoma skin cancer, curatively treated in situ disease) Note: This includes a second current breast primary malignancy (ie, bilateral breast cancer) * history of DCIS (except those treated with mastectomy \>5 years prior to current diagnosis) * History of, or current, ILD/pneumonitis * Prior systemic therapy for the treatment of breast cancer * Previous treatment with anthracyclines, cyclophosphamide or taxanes for any malignancy

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Conditions

The condition(s) this trial relates to.

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 Breast neoplasms HER2-positive early breast cancer

Contacts and locations

Locations

Research Site

Springdale, Arkansas, 72762, United States
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Beverly Hills, California, 90211, United States
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Glendale, California, 91204, United States
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Los Alamitos, California, 90720, United States
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Orange, California, 92868, United States
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New Haven, Connecticut, 06510, United States
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Fort Wayne, Indiana, 46804, United States
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Lexington, Kentucky, 40503, United States
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Louisville, Kentucky, 40202, United States
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Shreveport, Louisiana, 71101, United States
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Minneapolis, Minnesota, 55407, United States
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Las Vegas, Nevada, 89102, United States
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East Brunswick, New Jersey, 08816, United States
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Summit, New Jersey, 07901, United States
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Commack, New York, 11725, United States
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Durham, North Carolina, 27710, United States
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Greenville, South Carolina, 29607, United States
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Germantown, Tennessee, 38138, United States
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Nashville, Tennessee, 37203, United States
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Fort Worth, Texas, 76104, United States
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Ogden, Utah, 84405, United States
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Tacoma, Washington, 98405, United States
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Goiânia, 74000-000, Brazil
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Ijuí, 98700-000, 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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São Paulo, 01221-020, Brazil
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São Paulo, 01229-010, Brazil
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Panagyurishte, 4500, Bulgaria
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Sofia, 1330, Bulgaria
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Edmonton, Alberta, T6G 1Z2, Canada
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Toronto, Ontario, M5G 1X5, Canada
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Montreal, Quebec, H4A-3J1, Canada
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Québec, Quebec, G1S 4L8, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Montreal, H3T 1E2, Canada
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Beijing, 100039, China
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Changsha, 410008, China
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Changsha, 410013, China
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Chongqing, 400030, China
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Guangzhou, 510060, China
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Guangzhou, 510080, China
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Guangzhou, 510700, China
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Kunming, 650118, China
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Nanning, 530021, China
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Qingdao, 266100, China
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Shanghai, 200032, China
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Shenyang, 110001, China
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Tianjin, 300060, China
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Wuhan, 430060, China
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Wuhan, 430079, China
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Zhengzhou, 450008, China
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Augsburg, 86156, Germany
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Berlin, 10117, Germany
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Erlangen, 91054, Germany
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Hamburg, 20357, Germany
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Heidelberg, 69120, Germany
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Kiel, 24105, Germany
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Leipzig, 4103, Germany
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Mönchengladbach, 41061, Germany
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München, 81377, Germany
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Münster, 48149, Germany
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Paderborn, 33098, Germany
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Tübingen, 72076, Germany
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Gurgaon, 122001, India
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Howrah, 711103, India
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Nagpur, 440001, India
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Nashik, 422002, India
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New Delhi, 110 085, India
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New Delhi, 110029, India
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Raipur, 492001, India
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Rishikesh, 249203, India
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Surat, 395002, India
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Thiruvananthapuram, 695011, India
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Bologna, 40138, Italy
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Candiolo, 10060, Italy
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Livorno, 57100, Italy
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Milan, 20132, Italy
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Naples, 80131, Italy
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Negrar, 37024, Italy
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Padova, 35128, Italy
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Roma, 00168, Italy
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Rozzano, 20089, Italy
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Chūōku, 104-8560, Japan
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Chūōku, 862-8655, Japan
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Hidaka-shi, 350-1298, Japan
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Hiroshima, 734-8551, Japan
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Kawasaki-shi, 216-8511, Japan
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Kōtoku, 135-8550, Japan
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Nagoya, 466-8560, Japan
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Nagoya, 467-8602, Japan
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Ota-shi, 373-8550, Japan
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Shinjuku-ku, 162-8655, Japan
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Lima, 15033, Peru
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Lima, LIMA 29, Peru
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Lima, Lima 32, Peru
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Lima, LIMA 34, Peru
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Bacolod, 6100, Philippines
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Cebu City, 6000, Philippines
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Davao City, 8000, Philippines
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Iloilo City, 5000, Philippines
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Quezon City, 1112, Philippines
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San Juan City, Philippines
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Bialystok, 15-027, Poland
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Biała Podlaska, 21-500, Poland
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Bydgoszcz, 85-796, Poland
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Koszalin, 75-581, Poland
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Lublin, 20-090, Poland
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Rzeszów, 30-055, Poland
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Warsaw, 02-781, Poland
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Moscow, 117997, Russia
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Moscow, 143423, Russia
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Saint Petersburg, 190020, Russia
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Saint Petersburg, 197758, 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, 3354, Saudi Arabia
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Goyang-si, 10408, 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, 06273, South Korea
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Seoul, 06351, South Korea
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Barcelona, 08028, Spain
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Barcelona, 08035, Spain
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Madrid, 28007, Spain
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Madrid, 28040, Spain
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Seville, 41013, Spain
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Vigo, 36312, Spain
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Kaohsiung City, 82445, Taiwan
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Taichung, 40443, Taiwan
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Tainan, 710, Taiwan
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Taipei, 100, Taiwan
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Taipei, 11217, Taiwan
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Taipei, 114, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10210, Thailand
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Chiang Mai, 50200, Thailand
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Hat Yai, 90110, Thailand
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Khon Kaen, 40002, Thailand

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