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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

Breast Tumors

Interventions

DS-8201a

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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