Etude : DAIICHI 302 / DS8201-A-U302



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : DAIICHI 302

Nom : DS8201-A-U302

Traitement : Métastasique ou localement avancé

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 06/08/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Étude de phase III multicentrique randomisée en ouvert, comparant le DS-8201a, un anticorps conjugué anti-HER2, au traitement de référence, l’ado-trastuzumab emtansine (T-DM1), chez les patients atteints d’un cancer du sein HER2 positif, non résécable et/ou métastatique, préalablement traités par trastuzumab et taxanes

Spécialité : Seins, organes génitaux de la femme
Localisation : C50 - Tumeur maligne du sein
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : 2 treatment arms:
- Experimental: Trastuzumab deruxtecan (DS-8201a)
- Active Comparator: Ado-trastuzumab emtansine (T-DM1)

Phase : III

Stade : Localement avancé à Métastatique

2
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Is the age of majority in their country
- Has pathologically documented breast cancer that:
-> is unresectable or metastatic
-> has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
-> was previously treated with trastuzumab and taxane in the advanced/metastatic setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane
- Has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy)
- Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, agrees to provide a fresh biopsy.
- If of reproductive/childbearing potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study for at least 4.5 months after the last dose of DS-8201a or 7 months after the last dose of T-DM1
- Has adequate renal and hepatic function

Critères de non-inclusion : - Has previously been treated with an anti-HER2 antibody drug conjugate (ADC)
- Has uncontrolled or significant cardiovascular disease
- Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
- Has spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
-> Participants with clinically inactive brain metastases may be included in the study.
-> Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03529110
Promoteur :
DAIICHI SANKYO
Type de sponsor : Industriel
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN

Investigateur :
Christelle LEVY

TEC / ARC / IDE :
Sara GROSSI
s.grossi@
baclesse.unicancer.fr

Ouverture de l'essai : OUVERT

MAJ : 01/04/2019