Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)
NCT ID: NCT04784715
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1157 participants
INTERVENTIONAL
2021-04-26
2029-12-30
Brief Summary
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Detailed Description
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The study aims to evaluate the efficacy, and safety of trastuzumab deruxtecan, alone or with pertuzumab, compared with the standard of care treatment (taxane \[docetaxel or paclitaxel\], trastuzumab and pertuzumab). This study aims to see if trastuzumab deruxtecan allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. This study is also looking to see how the treatment and the cancer affects patients' quality of life.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
Arm A - trastuzumab deruxtecan with pertuzumab-matching placebo Arm B - trastuzumab deruxtecan with pertuzumab Arm C - standard of care (taxane \[docetaxel or paclitaxel\], trastuzumab and pertuzumab)
TREATMENT
NONE
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.
Study Groups
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Arm A
Trastuzumab deruxtecan (T-DXd) plus pertuzumab-matching placebo
Trastuzumab deruxtecan
Administered by intravenous infusion
Placebo
Administered by intravenous infusion
Arm B
Trastuzumab deruxtecan (T-DXd) plus pertuzumab
Trastuzumab deruxtecan
Administered by intravenous infusion
Pertuzumab
Administered by intravenous infusion
Arm C
Standard of care (Taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab)
Taxane
Investigator's choice of docetaxel or paclitaxel administered by intravenous infusion
Pertuzumab
Administered by intravenous infusion
Trastuzumab
Administered by intravenous infusion
Interventions
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Trastuzumab deruxtecan
Administered by intravenous infusion
Placebo
Administered by intravenous infusion
Taxane
Investigator's choice of docetaxel or paclitaxel administered by intravenous infusion
Pertuzumab
Administered by intravenous infusion
Trastuzumab
Administered by intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
130 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Tucson, Arizona, United States
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Springdale, Arkansas, United States
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Glendale, California, United States
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Glendale, California, United States
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Longmont, Colorado, United States
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Miami, Florida, United States
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Palm Bay, Florida, United States
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Plantation, Florida, United States
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Atlanta, Georgia, United States
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Louisville, Kentucky, United States
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Silver Spring, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Jackson, Mississippi, United States
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Las Vegas, Nevada, United States
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Summit, New Jersey, United States
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New York, New York, United States
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Shirley, New York, United States
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York, Pennsylvania, United States
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Germantown, Tennessee, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Denton, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Shenandoah, Texas, United States
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Tyler, Texas, United States
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Norfolk, Virginia, United States
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Roanoke, Virginia, United States
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Tacoma, Washington, United States
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Buenos Aires, , Argentina
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CABA, , Argentina
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CABA, , Argentina
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Caba, , Argentina
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Capital Federal, , Argentina
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Cipolletti, , Argentina
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Ciudad de Buenos Aires, , Argentina
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La Plata, , Argentina
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Mar del Plata, , Argentina
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Rosario, , Argentina
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Rosario, , Argentina
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San Salvador de Jujuy, , Argentina
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Brussels, , Belgium
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Brussels, , Belgium
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Charleroi, , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Namur, , Belgium
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Florianópolis, , Brazil
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Goiânia, , Brazil
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Londrina, , Brazil
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Natal, , Brazil
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Porto Alegre, , Brazil
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Ribeirão Preto, , Brazil
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São Paulo, , Brazil
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Sorocaba, , Brazil
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Vitória, , Brazil
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Calgary, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Barrie, Ontario, Canada
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Kitchener, Ontario, Canada
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Newmarket, Ontario, Canada
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North York, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Ste-Foy, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Changchun, , China
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Changsha, , China
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Changsha, , China
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Chengdu, , China
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Chongqing, , China
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Chongqing, , China
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Dalian, , China
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Guangzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Harbin, , China
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Kunming, , China
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Nanchang, , China
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Nanjing, , China
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Nanjing, , China
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Nanning, , China
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Qingdao, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Shenzhen, , China
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Tianjin, , China
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Wuhan, , China
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Wuhan, , China
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Wuhan, , China
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Xi'an, , China
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Xi'an, , China
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Yinchuan, , China
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Zhengzhou, , China
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Copenhagen O, , Denmark
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Sønderborg, , Denmark
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Vejle, , Denmark
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Avignon, , France
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Besançon, , France
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Bordeaux, , France
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Caen, , France
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Le Mans, , France
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Montpellier, , France
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Montpellier, , France
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Nice, , France
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Paris, , France
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Pierre-Bénite, , France
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Rennes, , France
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Saint-Cloud, , France
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Saint-Herblain, , France
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Toulouse, , France
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Vandœuvre-lès-Nancy, , France
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Berlin, , Germany
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Dresden, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Frankfurt am Main, , Germany
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Freiburg im Breisgau, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Leipzig, , Germany
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Münster, , Germany
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Paderborn, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Győr, , Hungary
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Kecskemét, , Hungary
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Nyíregyháza, , Hungary
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Szolnok, , Hungary
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Ahmedabad, , India
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Bangalore, , India
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Bengaluru, , India
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Calicut, , India
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Gurgaon, , India
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Mysuru, , India
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Nashik, , 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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Haifa, , Israel
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Jerusalem, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Bergamo, , Italy
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Candiolo, , Italy
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Genova, , Italy
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Livorno, , Italy
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Rozzano, , Italy
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Udine, , Italy
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Akashi-shi, , Japan
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Aomori, , Japan
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Bunkyō City, , Japan
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Chiba, , Japan
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Chūōku, , Japan
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Fukushima, , Japan
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Hidaka-shi, , Japan
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Hiroshima, , Japan
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Hiroshima, , Japan
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Isehara-shi, , Japan
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Kagoshima, , Japan
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Kawasaki-shi, , Japan
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Kobe, , Japan
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Kōtoku, , Japan
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Kyoto, , Japan
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Matsuyama, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Niigata, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Shinagawa-ku, , Japan
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Shinjuku-ku, , Japan
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Shinjuku-ku, , Japan
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Shizuoka, , Japan
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Tsu, , Japan
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Yokohama, , Japan
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Alc. Cuauhtémoc, , Mexico
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Estado de México, , Mexico
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Guadalajara, , Mexico
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Metepec, , Mexico
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Nuevo León, , Mexico
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Veracruz, , Mexico
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Arequipa, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Baguio City, , 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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Manila, , Philippines
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Quezon City, , Philippines
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San Juan City, , Philippines
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Bucharest, , Romania
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Floreşti, , Romania
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Moscow, , Russia
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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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Yaroslavl, , 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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Cape Town, , South Africa
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Cape Town, , South Africa
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George, , South Africa
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Johannesburg, , South Africa
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Johannesburg, , South Africa
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Port Elizabeth, , South Africa
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Pretoria, , South Africa
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Rondebosch, , South Africa
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Soweto, , South Africa
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Cheonan-si, , South Korea
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Daegu, , South Korea
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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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Seoul, , South Korea
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Seoul, , South Korea
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Alicante, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Majadahonda, , Spain
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Seville, , Spain
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Gothenburg, , Sweden
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Örebro, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Vaxjo, , Sweden
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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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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Karşıyaka, , Turkey (Türkiye)
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Malatya, , Turkey (Türkiye)
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Samsun, , Turkey (Türkiye)
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Buckhurst Hill, , United Kingdom
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Edinburgh, , United Kingdom
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Guildford, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Swansea, , United Kingdom
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Taunton, , United Kingdom
Countries
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References
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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. 2025 Oct 29. doi: 10.1056/NEJMoa2508668. Online ahead of print.
Related Links
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BreastCancerStudyLocator.com
Daiichi Sankyo Contact for Clinical Trial Information Phone: 908-992-6400
Other Identifiers
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2023-507904-30-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-004074-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D967UC00001
Identifier Type: -
Identifier Source: org_study_id