Etude : DAIICHI 303 / DS8201-A-U303



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : DAIICHI 303

Nom : DS8201-A-U303

Traitement : Métastasique ou localement avancé

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 11/06/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Étude de phase 3, multicentrique, randomisée, en ouvert, contrôlée par comparateur actif portant sur le DS-8201a, un conjugué anticorps-médicament (CAM) anti-HER2, par rapport au traitement choisi par le médecin pour des patients atteints d’un cancer du sein avec taux d’HER2 faible non résécable et/ou métastatique

Spécialité : Seins, organes génitaux de la femme
Localisation : C50 - Tumeur maligne du sein
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : This is a randomized, 2-arm, Phase 3, open-label, multicenter study to compare the safety and efficacy of DS8201a versus the physician's choice (2:1) in HER2-low, unresectable and/or metastatic breast cancer subjects.

The study is expected to enroll ~360 DS-8201a subjects and ~180 physician's choice subjects:

60 hormone receptor (HR)-negative
240 HR-positive who have had prior therapy with a cyclin-dependent kinase (CDK) 4/6 inhibitor
240 HR-positive who are naive to treatment with CDK 4/6
There will be approximately 161 sites, including but not limited to, North America, Western Europe, and Asia.

There are planned follow-up visits after permanent discontinuation of study treatment to obtain information about subsequent treatment(s) and survival status.

The Sponsor proposes to define a new HER2-low population in this trial including tumors with IHC 1+ and IHC 2+/ISH- HER2 expression.

2 treatment arms:
- Experimental: DS-8201a
DS-8201a is administered as an intravenous (IV) infusion every 21 days (Q3W), initially for at least 90 minutes, then, if there is no infusion-related reaction, for a minimum of 30 minutes thereafter.
- Active Comparator: Physician's Choice
Physician's choice comparative therapy will be administered in accordance with the locally approved label. The physician's choice is predefined, prior to randomization, from the following options:
Capecitabine
Eribulin
Gemcitabine
Paclitaxel
Nab-paclitaxel

Phase : III

Stade : Localisé à Métastatique

2, 3
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 low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
-> Is HR-positive or HR-negative
-> Has progressed on, and would no longer benefit from, endocrine therapy
-> Has been treated with 1 to 2 prior lines of chemotherapy/adjuvant in the metastatic setting
- Has documented radiologic progression (during or after most recent treatment)
- Has adequate tumor samples available or is wiling to provide fresh biopsies prior to randomization for:
-> assessment of HER2 status
-> assessment of post-treatment status
- Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Has at least 1 protocol-defined measurable lesion
- Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
- If of reproductive/childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels)

Critères de non-inclusion : - Is ineligible for all options in the physician's choice arm
- Has breast cancer ever assessed with high-HER2 expression
- Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate
- Has uncontrolled or significant cardiovascular disease
- Has spinal cord compression or clinically active central nervous system metastases
- Has history, current, or suspicion of interstitial lung disease/pneumonitis
- Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03734029
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 : 11/06/2019