Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
NCT ID: NCT04494425
Last Updated: 2025-06-18
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
866 participants
INTERVENTIONAL
2020-07-24
2026-06-19
Brief Summary
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Detailed Description
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The study aims to evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy. 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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Trastuzumab deruxtecan
Trastuzumab deruxtecan (T-DXd; DS-8201a) arm
Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
Standard of Care
Investigator's choice standard of care chemotherapy (capecitabine, paclitaxel, nab-paclitaxel) arm
Capecitabine
Investigator's choice standard of care single agent chemotherapy; capecitabine tablets will be given orally.
Paclitaxel
Investigator's choice standard of care single agent chemotherapy; paclitaxel by intravenous infusion.
Nab-Paclitaxel
Investigator's choice standard of care single agent chemotherapy; nab-paclitaxel by intravenous infusion
Interventions
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Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
Capecitabine
Investigator's choice standard of care single agent chemotherapy; capecitabine tablets will be given orally.
Paclitaxel
Investigator's choice standard of care single agent chemotherapy; paclitaxel by intravenous infusion.
Nab-Paclitaxel
Investigator's choice standard of care single agent chemotherapy; nab-paclitaxel 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. 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
Exclusion Criteria
* 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)
18 Years
105 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Scottsdale, Arizona, United States
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Springdale, Arkansas, United States
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Duarte, California, United States
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Los Angeles, California, United States
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Aurora, Colorado, United States
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Lakewood, Colorado, United States
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Washington D.C., District of Columbia, United States
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Jacksonville, Florida, United States
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Kansas City, Kansas, United States
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Louisville, Kentucky, United States
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Bethesda, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Summit, New Jersey, United States
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Westbury, New York, United States
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Columbus, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Norfolk, Virginia, United States
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Seattle, Washington, United States
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Madison, Wisconsin, 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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Ciudad de Buenos Aires, , Argentina
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Córdoba, , 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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Adelaide, , Australia
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Birtinya, , Australia
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Darlinghurst, , Australia
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Murdoch, , Australia
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South Brisbane, , Australia
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St Leonards, , Australia
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Waratah, , Australia
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Graz, , Austria
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Innsbruck, , Austria
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Anderlecht, , 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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Roeselare, , Belgium
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Sint-Niklaas, , Belgium
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Barretos, , Brazil
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Belo Horizonte, , 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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Rio de Janeiro, , Brazil
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Sorocaba, , Brazil
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Toronto, CA, Canada
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London, 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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Sherbrooke, Quebec, Canada
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Baoding, , China
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Beijing, , China
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Changchun, , China
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Changsha, , China
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Nanjing, , China
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Nanjing, , China
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Nanning, , China
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Shanghai, , China
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Shenyang, , China
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Tianjin, , China
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Ürümqi, , 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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Zhengzhou, , China
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Aalborg, , Denmark
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Copenhagen Ø, , Denmark
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Odense, , Denmark
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Vejle, , Denmark
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Avignon, , France
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Rennes, , France
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Saint-Cloud, , France
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Berlin, , Germany
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Münster, , Germany
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Velbert, , Germany
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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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Tatabánya, , Hungary
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Bengaluru, , India
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Calicut, , India
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Kolkata, , India
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Marg Jaipur, , India
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New Delhi, , India
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Surat, , India
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Thiruvananthapuram, , India
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Haifa, , Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Kfar Saba, , 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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Aviano, , Italy
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Sapporo, , 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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Guadalajara Jalisco, , Mexico
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Monterrey, , Mexico
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Nuevo León, , Mexico
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Amsterdam, , Netherlands
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Breda, , Netherlands
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Hengelo, , Netherlands
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Leeuwarden, , Netherlands
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Rotterdam, , Netherlands
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Sittard-Geleen, , Netherlands
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Bydgoszcz, , Poland
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Koszalin, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Rzeszów, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Krasnodar, , Russia
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Moscow, , Russia
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Moscow, , 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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Riyadh, , Saudi Arabia
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Bukit Merah, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Daegu, , South Korea
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Goyang-si, , South Korea
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Incheon, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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A Coruña, , Spain
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San Sebastián, , Spain
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Seville, , Spain
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Valencia, , 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 City, , Taiwan
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Tainan City, , 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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Cambridge, , United Kingdom
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Cardiff, , United Kingdom
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Edinburgh, , United Kingdom
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Guildford, , United Kingdom
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Leeds, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Northwood, , United Kingdom
Countries
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References
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Bardia A, Hu X, Dent R, Yonemori K, Barrios CH, O'Shaughnessy JA, Wildiers H, Pierga JY, Zhang Q, Saura C, Biganzoli L, Sohn J, Im SA, Levy C, Jacot W, Begbie N, Ke J, Patel G, Curigliano G; DESTINY-Breast06 Trial Investigators. Trastuzumab Deruxtecan after Endocrine Therapy in Metastatic Breast Cancer. N Engl J Med. 2024 Dec 5;391(22):2110-2122. doi: 10.1056/NEJMoa2407086. Epub 2024 Sep 15.
Tarantino P, Tolaney SM, Curigliano G. Trastuzumab deruxtecan (T-DXd) in HER2-low metastatic breast cancer treatment. Ann Oncol. 2023 Oct;34(10):949-950. doi: 10.1016/j.annonc.2023.07.003. Epub 2023 Jul 26. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AZ Breast Cancer Study Navigators
Daiichi Sankyo Contact for Clinical Trial Information Phone: 908-992-6400
D9670C00001\_CSP\_Redacted
Other Identifiers
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2023-505554-18-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-004493-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D9670C00001
Identifier Type: -
Identifier Source: org_study_id
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