Etude : MO42319 / KATE3



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : MO42319 / KATE3

Situation thérapeutique : Métastatique ou localement avancé

Traitement : Immunothérapie / Thérapie ciblée

Cadre réglementaire : RIPH1

Dernière MÀJ : 29/11/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude multicentrique de phase III, randomisée, en double aveugle, contrôlée par placebo, évaluant l’efficacité et la tolérance du trastuzumab emtansine en association avec atezolizumab ou un placebo chez des patients atteints d’un cancer du sein HER2-positif et PD-L1 positif localement avancé ou métastatique ayant déjà reçu un traitement à base de trastuzumab (+\- pertuzumab) et de taxane (KATE3)

Spécialité : Seins, organes génitaux de la femme
Localisation : C50 - Tumeur maligne du sein
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2‑positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.

STUDY ARMS:
- Active Comparator: Arm A: Trastuzumab Emtansine and Placebo
Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor.

- Experimental: Arm B: Trastuzumab Emtansine and Atezolizumab
Atezolizumab 1200 mg IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor.

MAIN OBJECTIVE:
To demonstrate superiority of the experimental over the control treatment with respect to progression-free survival (PFS) and overall survival (OS).

SECONDARY OBJECTIVES:
• To evaluate the efficacy of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo beyond PFS and OS;
• To evaluate the safety of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo;
• To characterize the pharmacokinetics (PK) of trastuzumab emtansine and atezolizumab when given in combination;
• To evaluate the immune response to atezolizumab and trastuzumab emtansine when given in combination.

Phase : III

Stade : Localement avancé à Métastatique

2, 3
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - HER2+ and PD-L1+ locally advanced (LABC) or metastatic breast cancer (MBC)
- Progression must have occurred during most recent treatment for LABC/MBC or during, or within 6 months after completing, neoadjuvant and/or adjuvant therapy
- Prior treatment with trastuzumab (+/- pertuzumab) and taxane in the neoadjuvant and/or adjuvant, locally advanced, or metastatic setting
- No more than two prior lines of therapy in the metastatic setting
- Measurable disease per RESIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy >= 6 months
- Adequate hematologic and end-organ function
- For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs
- For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

Critères de non-inclusion : - Prior treatment with trastuzumab emtansine in metastatic setting
- History of exposure to cumulative doses of anthracyclines
- Symptomatic or actively progressing central nervous system (CNS) metastases; asymptomatic CNS lesions ≤ 2cm without clinical requirement for local intervention or asymptomatic patients with treated CNS lesions are eligible
- Current Grade >= 3 peripheral neuropathy
- Cardiopulmonary dysfunction
- History of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation and malignancies with a negligible risk of metastasis or death
- History of leptomeningeal disease
- Active or history of autoimmune disease or immune deficiency
- Active hepatitis B, hepatitis C and/or tuberculosis
- Prior allogeneic stem cell or solid organ transplantation
- Receipt of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, during treatment, or within 5 months following the last dose of study treatment
- Pregnancy or lactation
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04740918
Promoteur :
HOFFMANN-LA ROCHE
Type de sponsor : Industriel
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Oscar Lambret - 3 Rue Frédéric Combemale - 59000 LILLE

Investigateur :
Docteur Emilie KACZMAREK

TEC / ARC / IDE :
Unité Intégrée de Recherche Clinique
investigation@
o-lambret.fr
03.20.29.59.35

Statut de l'essai : OUVERT

MAJ : 29/09/2021