Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)
Phase III Study of Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)
3 other identifiers
interventional
1,157
27 countries
283
Brief Summary
The study will evaluate the efficacy and safety of trastuzumab deruxtecan (also known as T-DXd, DS-8201a), either alone or in combination with pertuzumab, in treating patients with Human epidermal growth factor receptor 2 (HER2)-positive breast cancer as a first line of treatment in the metastatic setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2021
Longer than P75 for phase_3
283 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2021
CompletedFirst Posted
Study publicly available on registry
March 5, 2021
CompletedStudy Start
First participant enrolled
April 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2029
February 20, 2026
February 1, 2026
5.2 years
February 19, 2021
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment
Defined as time from date of randomisation until the date of objective radiological disease progression according to Blinded Independent Central Review (BICR) using RECIST 1.1 or death by any cause.
Until progression or death, assessed up to approximately 60 months
Secondary Outcomes (14)
Progression Free Survival (PFS) by Investigator assessment
Until progression or death, assessed up to approximately 60 months
Overall Survival (OS)
Until death, assessed up to approximately 104 months
Objective Response Rate (ORR) by BICR and Investigator assessment
Until progression or death (in the absence of progression), assessed up to approximately 60 months
Duration of Response (DoR) by BICR and Investigator Assessment
Until progression or death (in the absence of progression), assessed up to approximately 60 months
Time to second progression or death (PFS2) by Investigator assessment
Assessed up to approximately 104 months
- +9 more secondary outcomes
Study Arms (3)
Arm A
EXPERIMENTALTrastuzumab deruxtecan (T-DXd) plus pertuzumab-matching placebo
Arm B
EXPERIMENTALTrastuzumab deruxtecan (T-DXd) plus pertuzumab
Arm C
ACTIVE COMPARATORStandard of care (Taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab)
Interventions
Administered by intravenous infusion
Investigator's choice of docetaxel or paclitaxel administered by intravenous infusion
Eligibility Criteria
You may qualify if:
- Patients must be ≥18 years of age
- Pathologically documented breast cancer that:
- is advanced or metastatic
- is locally assessed and prospectively centrally confirmed as HER2-positive (IHC3+ or ISH+)
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Daiichi Sankyocollaborator
Study Sites (283)
Research Site
Tucson, Arizona, 85711, United States
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Springdale, Arkansas, 72762, United States
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Glendale, California, 91204, United States
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Glendale, California, 91206, United States
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Longmont, Colorado, 80501, United States
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Miami, Florida, 33176, United States
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Palm Bay, Florida, 32909, United States
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Plantation, Florida, 33324, United States
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Atlanta, Georgia, 30318, United States
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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
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Las Vegas, Nevada, 89128, United States
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Summit, New Jersey, 07901, United States
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New York, New York, 10065, United States
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Shirley, New York, 11967, United States
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York, Pennsylvania, 17403, United States
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Germantown, Tennessee, 38138, United States
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Dallas, Texas, 75203, United States
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Dallas, Texas, 75246, United States
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Denton, Texas, 76201, United States
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Houston, Texas, 77090, United States
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San Antonio, Texas, 78240, United States
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Shenandoah, Texas, 77380, United States
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Tyler, Texas, 75702, United States
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Norfolk, Virginia, 23502, United States
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Roanoke, Virginia, 24014, United States
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Tacoma, Washington, 98405, 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, C1118AAT, Argentina
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Capital Federal, C1417DTB, Argentina
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Cipolletti, 8234, Argentina
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Ciudad de Buenos Aires, 1280, 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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San Salvador de Jujuy, 4600, Argentina
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Brussels, 1160, 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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Florianópolis, 88034-000, Brazil
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Goiânia, 74000-000, Brazil
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Londrina, 86015-520, Brazil
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Natal, 59075-740, Brazil
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Porto Alegre, 90035-003, Brazil
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Ribeirão Preto, 14015-130, Brazil
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São Paulo, 03102-002, Brazil
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Sorocaba, 18030-005, Brazil
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Vitória, 29043-260, Brazil
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Calgary, Alberta, T2N 5G2, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Barrie, Ontario, L4M 6M2, Canada
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Kitchener, Ontario, N2G 1G3, Canada
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Newmarket, Ontario, L3Y 2P9, Canada
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North York, Ontario, M2K 1E1, Canada
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Toronto, Ontario, M5G 1X5, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H2X 3E4, Canada
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Montreal, Quebec, H3T 1M5, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Ste-Foy, Quebec, G1V 4G2, Canada
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Saskatoon, Saskatchewan, S7N 4H4, Canada
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Beijing, 100039, China
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Beijing, 100044, China
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Beijing, 100191, 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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Chengdu, 610041, China
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Chongqing, 400016, China
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Chongqing, 400030, China
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Dalian, 116011, 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, 310022, China
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Harbin, 150049, China
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Kunming, 650118, China
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Nanchang, 330009, China
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Nanjing, 210008, China
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Nanjing, 210029, China
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Nanning, 530021, China
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Qingdao, 266100, China
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Shanghai, 200025, China
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Shanghai, 200032, China
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Shenyang, 110001, China
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Shenzhen, 518036, China
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Tianjin, 300060, China
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Wuhan, 430022, China
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Wuhan, 430030, China
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Wuhan, 430060, China
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Xi'an, 710004, China
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Xi'an, 710061, China
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Yinchuan, 750004, China
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Zhengzhou, 450008, China
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Copenhagen O, 2100, Denmark
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Sønderborg, 6400, Denmark
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Vejle, 7100, Denmark
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Avignon, 84000, France
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Besançon, 25000, France
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Bordeaux, 33030, France
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Caen, 14076, France
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Le Mans, 72000, France
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Montpellier, 34070, France
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Montpellier, 34298, France
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Nice, 06189, France
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Paris, 75005, France
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Pierre-Bénite, 69495, France
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Rennes, 35042, France
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Saint-Cloud, 92210, France
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Saint-Herblain, 44805, France
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Toulouse, 31059, France
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Vandœuvre-lès-Nancy, 54519, France
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Berlin, 10117, Germany
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Dresden, 1307, Germany
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Erlangen, 91054, Germany
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Essen, 45136, Germany
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Frankfurt am Main, 60431, Germany
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Freiburg im Breisgau, 79110, Germany
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Hamburg, 20357, Germany
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Heidelberg, 69120, Germany
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Leipzig, 04103, Germany
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Münster, 48149, Germany
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Paderborn, 33161, Germany
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Budapest, 1062, Hungary
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Budapest, 1082, Hungary
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Budapest, 1115, 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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Ahmedabad, 380060, India
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Bangalore, 560027, India
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Bengaluru, 560099, India
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Calicut, 673601, India
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Gūrgaon, 122001, India
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Mysuru, 570017, India
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Nashik, 422009, India
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Nashik, 422011, India
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New Delhi, 110075, India
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New Delhi, 110085, India
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Haifa, 31096, Israel
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Jerusalem, 9112001, Israel
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Petah Tikva, 4941492, Israel
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Ramat Gan, 5266202, Israel
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Tel Aviv, 64239, Israel
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Bergamo, 24127, Italy
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Candiolo, 10060, Italy
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Genova, 16132, Italy
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Livorno, 57100, Italy
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Milan, 20141, Italy
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Naples, 80131, Italy
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Padua, 35128, Italy
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Rozzano, 20089, Italy
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Udine, 33100, Italy
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Akashi-shi, 673-8558, Japan
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Aomori, 030-8553, 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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Fukushima, 960-1295, Japan
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Hidaka-shi, 350-1298, Japan
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Hiroshima, 730-8518, Japan
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Hiroshima, 734-8551, Japan
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Isehara-shi, 259-1193, Japan
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Kagoshima, 892-0833, Japan
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Kawasaki-shi, 216-8511, Japan
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Kobe, 650-0047, Japan
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Kōtoku, 135-8550, Japan
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Kurume-shi, 830-0011, Japan
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Kyoto, 606-8507, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 464-8681, Japan
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Nagoya, 467-8602, 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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Ota-shi, 373-8550, Japan
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Sapporo, 003-0804, Japan
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Sendai, 980-8574, Japan
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Shinagawa-ku, 142-8666, Japan
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Shinjuku-ku, 160-0023, Japan
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Shinjuku-ku, 162-8655, 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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Estado de México, 50080, Mexico
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Guadalajara, 44680, Mexico
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Metepec, 52140, Mexico
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Nuevo León, 66278, Mexico
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Veracruz, 91910, Mexico
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Arequipa, AREQUIPA01, Peru
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Lima, 15033, Peru
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Lima, 15036, Peru
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Lima, LIMA 29, Peru
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Lima, LIMA 34, Peru
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Baguio City, 2600, 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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Manila, 1000, Philippines
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Quezon City, 1112, Philippines
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San Juan City, 1500, Philippines
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Bucharest, 011461, Romania
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Floreşti, 407280, Romania
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Moscow, 121205, Russia
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Moscow, 129090, Russia
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Moscow, 143442, Russia
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Saint Petersburg, 190020, 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, 22384, Saudi Arabia
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Jeddah, 23214, Saudi Arabia
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Riyadh, 11211, Saudi Arabia
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Riyadh, 11426, Saudi Arabia
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Cape Town, 7570, South Africa
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Cape Town, 7925, South Africa
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George, 6529, South Africa
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Johannesburg, 2193, South Africa
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Johannesburg, 2196, South Africa
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Port Elizabeth, 6045, South Africa
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Pretoria, 0081, South Africa
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Rondebosch, 7700, South Africa
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Soweto, 2013, South Africa
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Cheonan-si, 31151, South Korea
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Daegu, 41404, South Korea
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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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Seoul, 06591, South Korea
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Seoul, 08308, South Korea
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Alicante, 03010, Spain
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Barcelona, 08028, Spain
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Barcelona, 08036, Spain
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Barcelona, 8035, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Majadahonda, 28222, Spain
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Seville, 41009, 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, 75185, Sweden
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Vaxjo, 35185, Sweden
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Taichung, 40443, Taiwan
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Tainan, 70403, Taiwan
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Taipei, 100, 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 District, 333, Taiwan
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Adana, 01330, Turkey (Türkiye)
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Ankara, 06520, Turkey (Türkiye)
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Ankara, 06800, Turkey (Türkiye)
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Cordaleo, 35575, Turkey (Türkiye)
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Malatya, 44280, Turkey (Türkiye)
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Samsun, 55200, Turkey (Türkiye)
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Buckhurst Hill, IG9 5HX, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Guildford, GU2 7WG, United Kingdom
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London, NW1 2PG, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Swansea, SA2 8QA, United Kingdom
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Taunton, TA1 5DA, United Kingdom
Related Publications (1)
Tolaney SM, Jiang Z, Zhang Q, Barroso-Sousa R, Park YH, Rimawi MF, Saura C, Schneeweiss A, Toi M, Chae YS, Kemal Y, Chaudhari M, Sendur MAN, Yamashita T, Casalnuovo M, Danso MA, Liu J, Shetty J, Herbolsheimer P, Loibl S; DESTINY-Breast09 Trial Investigators. Trastuzumab Deruxtecan plus Pertuzumab for HER2-Positive Metastatic Breast Cancer. N Engl J Med. 2026 Feb 5;394(6):551-562. doi: 10.1056/NEJMoa2508668. Epub 2025 Oct 29.
PMID: 41160818DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This study is open-label with respect to the control arm. Pertuzumab/placebo in the experimental arms will be blinded to the investigator and patients. The study will be "Sponsor-blind". To maintain the integrity of the study, Sponsor personnel directly involved in study conduct will not undertake or have access to efficacy data aggregated by treatment group prior to final data readout for the primary endpoint.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2021
First Posted
March 5, 2021
Study Start
April 26, 2021
Primary Completion (Estimated)
July 6, 2026
Study Completion (Estimated)
December 30, 2029
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.