Spots Global Cancer Trial Database for A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer
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Trial Identification
Brief Title: A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer
Official Title: An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients With or Without Baseline Brain Metastasis With Previously Treated Advanced/Metastatic HER2-Positive Breast Cancer (DESTINY-Breast12)
Study ID: NCT04739761
Conditions
Interventions
Study Description
Brief Summary: This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic HER2-positive breast cancer whose disease has progressed on prior anti-HER2-based regimens and who received no more than 2 lines/regimens of therapy in the metastatic setting (excluding tucatinib).
Detailed Description: Approximately 500 eligible participants will be enrolled into 1 of 2 cohorts (250 participants in each cohort) according to the presence or absence of BMs at baseline. Cohort 1 will include participants without BM at baseline and Cohort 2 will consist of participants with BM at baseline. After study intervention discontinuation, all participants will undergo an end-of-treatment visit (within 7 days of discontinuation) and will be followed up for safety assessments 40 (+ up to 7) days after the discontinuation of all study intervention. All participants will be followed up for survival status and duration of treatment on subsequent therapies after intervention discontinuation every 3 months (± 14 days) from the date of the safety follow-up until death, withdrawal of consent, or the end of the study, as per defined in the protocol.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Boston, Massachusetts, United States
Research Site, Durham, North Carolina, United States
Research Site, Adelaide, , Australia
Research Site, Auchenflower, , Australia
Research Site, Clayton, , Australia
Research Site, St Leonards, , Australia
Research Site, Subiaco, , Australia
Research Site, Anderlecht, , Belgium
Research Site, Vancouver, British Columbia, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Copenhagen, , Denmark
Research Site, Herlev, , Denmark
Research Site, Odense C, , Denmark
Research Site, Helsinki, , Finland
Research Site, Tampere, , Finland
Research Site, Turku, , Finland
Research Site, Berlin, , Germany
Research Site, Dresden, , Germany
Research Site, Erlangen, , Germany
Research Site, Essen, , Germany
Research Site, Frankfurt, , Germany
Research Site, Hamburg, , Germany
Research Site, Hannover, , Germany
Research Site, Kiel, , Germany
Research Site, Mannheim, , Germany
Research Site, München, , Germany
Research Site, München, , Germany
Research Site, Münster, , Germany
Research Site, Tübingen, , Germany
Research Site, Cork, , Ireland
Research Site, Dublin, , Ireland
Research Site, Dublin, , Ireland
Research Site, Ancona, , Italy
Research Site, Bergamo, , Italy
Research Site, Catania, , Italy
Research Site, Milano, , Italy
Research Site, Napoli, , Italy
Research Site, Padova, , Italy
Research Site, Prato, , Italy
Research Site, Isehara, , Japan
Research Site, Kawasaki-shi, , Japan
Research Site, Sapporo-shi, , Japan
Research Site, Shinagawa-ku, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Den Haag, , Netherlands
Research Site, Maastricht, , Netherlands
Research Site, Bergen, , Norway
Research Site, Oslo, , Norway
Research Site, Oslo, , Norway
Research Site, Gdańsk, , Poland
Research Site, Kraków, , Poland
Research Site, Opole, , Poland
Research Site, Warszawa, , Poland
Research Site, Warszawa, , Poland
Research Site, Lisboa, , Portugal
Research Site, Lisboa, , Portugal
Research Site, Porto, , Portugal
Research Site, Barcelona, , Spain
Research Site, Barcelona, , Spain
Research Site, Bilbao (Vizcaya), , Spain
Research Site, Granada, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Salamanca, , Spain
Research Site, Santander, , Spain
Research Site, Santiago De Compostela-Coruña, , Spain
Research Site, Sevilla, , Spain
Research Site, Valencia, , Spain
Research Site, Göteborg, , Sweden
Research Site, Lund, , Sweden
Research Site, Uppsala, , Sweden
Research Site, Basel, , Switzerland
Research Site, Bellinzona, , Switzerland
Research Site, Lausanne, , Switzerland
Research Site, Luzern, , Switzerland
Research Site, Edinburgh, , United Kingdom
Contact Details
Name: Nadia Harbeck, MD, PhD
Affiliation: Head, Breast Center, Ludwig-Maximilians-University of Munich Department of Obstetrics and Gynecology Marchioninistr. 15, 81377 Munich, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: Nancy U. Lin, MD
Affiliation: Associate Chief, Division of Breast Oncology, Susan F. Smith Center for Women's Cancers Director, Metastatic Breast Cancer Program, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA 02215
Role: PRINCIPAL_INVESTIGATOR
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