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ACTIVE NOT RECRUITING
NCT05113251
PHASE3

Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.

Official title: A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd Followed by THP Compared to ddAC-THP in Participants With High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

927

Start Date

2021-10-25

Completion Date

2027-04-30

Last Updated

2026-02-23

Healthy Volunteers

No

Interventions

DRUG

Trastuzumab Deruxtecan

administered by intravenous infusion

DRUG

Paclitaxel

administered by intravenous infusion

DRUG

Trastuzumab

administered by intravenous infusion

DRUG

Pertuzumab

administered by intravenous infusion

DRUG

Doxorubicin

administered by intravenous infusion

DRUG

cyclophosphamide

administered by intravenous infusion

Locations (145)

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Springdale, Arkansas, United States

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Beverly Hills, California, United States

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Glendale, California, United States

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Los Alamitos, California, United States

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Orange, California, United States

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New Haven, Connecticut, United States

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Fort Wayne, Indiana, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Shreveport, Louisiana, United States

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Minneapolis, Minnesota, United States

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Las Vegas, Nevada, United States

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East Brunswick, New Jersey, United States

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Summit, New Jersey, United States

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Commack, New York, United States

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Durham, North Carolina, United States

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Greenville, South Carolina, United States

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Germantown, Tennessee, United States

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Nashville, Tennessee, United States

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Fort Worth, Texas, United States

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Ogden, Utah, United States

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Tacoma, Washington, United States

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Goiânia, Brazil

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Ijuí, Brazil

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Natal, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Panagyurishte, Bulgaria

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Sofia, Bulgaria

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Edmonton, Alberta, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Montreal, Canada

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Beijing, China

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Changsha, China

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Changsha, China

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Chongqing, China

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Guangzhou, China

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Guangzhou, China

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Guangzhou, China

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Kunming, China

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Nanning, China

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Qingdao, China

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Shanghai, China

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Shenyang, China

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Tianjin, China

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Wuhan, China

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Wuhan, China

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Zhengzhou, China

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Augsburg, Germany

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Berlin, Germany

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Erlangen, Germany

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Hamburg, Germany

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Heidelberg, Germany

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Kiel, Germany

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Leipzig, Germany

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Mönchengladbach, Germany

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München, Germany

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Münster, Germany

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Paderborn, Germany

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Tübingen, Germany

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Gūrgaon, India

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Howrah, India

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Nagpur, India

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Nashik, India

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New Delhi, India

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New Delhi, India

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Raipur, India

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Rishikesh, India

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Surat, India

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Thiruvananthapuram, India

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Bologna, Italy

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Candiolo, Italy

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Livorno, Italy

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Milan, Italy

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Naples, Italy

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Negrar, Italy

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Padova, Italy

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Roma, Italy

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Rozzano, Italy

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Chūōku, Japan

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Chūōku, Japan

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Hidaka-shi, Japan

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Hiroshima, Japan

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Kawasaki-shi, Japan

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Kōtoku, Japan

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Nagoya, Japan

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Nagoya, Japan

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Ota-shi, Japan

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Shinjuku-ku, Japan

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Bacolod, Philippines

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Cebu City, Philippines

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Davao City, Philippines

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Iloilo City, Philippines

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Quezon City, Philippines

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San Juan City, Philippines

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Bialystok, Poland

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Biała Podlaska, Poland

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Bydgoszcz, Poland

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Koszalin, Poland

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Lublin, Poland

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Rzeszów, Poland

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Warsaw, Poland

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Moscow, Russia

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Moscow, Russia

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Saint Petersburg, Russia

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Saint Petersburg, Russia

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Dammam, Saudi Arabia

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Jeddah, Saudi Arabia

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Jeddah, Saudi Arabia

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Riyadh, Saudi Arabia

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Riyadh, Saudi Arabia

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Goyang-si, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Barcelona, Spain

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Barcelona, Spain

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Madrid, Spain

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Madrid, Spain

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Seville, Spain

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Vigo, Spain

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taoyuan District, Taiwan

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Bangkok, Thailand

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Bangkok, Thailand

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Bangkok, Thailand

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Chiang Mai, Thailand

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Hat Yai, Thailand

Research Site

Khon Kaen, Thailand