Spots Global Cancer Trial Database for Study of DS-8201a, an Antibody Drug Conjugate for Advanced Breast Cancer Patients, With Biomarkers Analysis
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Trial Identification
Brief Title: Study of DS-8201a, an Antibody Drug Conjugate for Advanced Breast Cancer Patients, With Biomarkers Analysis
Official Title: Phase II, Open Label Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC) for Advanced Breast Cancer Patients, With Biomarkers Analysis to Characterize Response/Resistance to Therapy
Study ID: NCT04132960
Conditions
Interventions
Study Description
Brief Summary: Multicenter, open-label phase II trial assessing the efficacy of DS-8201a monotherapy in patients with metastatic breast cancer.
Detailed Description: The main objective is to evaluate the anti-tumor activity of DS-8201a in three cohorts of advanced breast cancer patients: * Cohort 1: HER2 over-expressing (HER2 IHC3+ or HER2 IHC2+/ISH+) * Cohort 2: HER2 low-expressing (IHC1+ or IHC2+/ISH-) * Cohort 3: HER2 non-expressing (IHC0+)
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Institut de Cancérologie de l'Ouest - Site Paul Papin, Angers, , France
Institut Bergonié, Bordeaux, , France
Centre François Baclesse, Caen, , France
Sasu Roc 37, Chambray Les Tours, , France
Centre Jean Perrin, Clermont-Ferrand, , France
Centre Oscar Lambret, Lille, , France
Centre Hospitalier Universitaire Dupuytren, Limoges, , France
Centre LĂ©on BĂ©rard, Lyon, , France
Institut Paoli Calmettes, Marseille, , France
Institut RĂ©gional du Cancer Montpellier (ICM), Montpellier, , France
Centre Antoine Lacassagne, Nice, , France
Institut Curie, Paris, , France
Institut Jean Godinot, Reims, , France
Centre EugĂšne Marquis, Rennes, , France
Institut Curie - HĂŽpital Huguenin, Saint-Cloud, , France
Institut de Cancérologie de l'Ouest - Site René Gauducheau, Saint-Herblain, , France
Institut de Cancérologie Lucien Neuwirth, Saint-Priest-en-Jarez, , France
Institut de Cancérologie Strasbourg Europe (ICANS), Strasbourg, , France
Institut Claudius Regaud, Toulouse, , France
Institut de Cancérologie de Lorraine, Vandoeuvre Les Nancy, , France
Gustave Roussy, Villejuif, , France
Contact Details
Name: VĂ©ronique DIERAS
Affiliation: Centre EugĂšne Marquis
Role: PRINCIPAL_INVESTIGATOR
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