étude de phase III sur le tucatinib ou un placebo avec le trastuzumab et le pertuzumab pour le cancer du sein métastatique HER2+

Essai clinique

Type : Industriel
Statut : Ouvert
Phase : III
Date d'ouverture : 07/03/2022
Date clôture : 30/06/2027
Promoteur : Seagen Inc.
Progression du cancer: À distance
Résumé :

This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.

Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).

In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in.

All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.

Domaines/spécialités :
  • Cancer du sein
Biomarqueurs :
  • HER2
Pathologies :
  • Tumeur maligne du sein - Cim10 : C50
Liens externes :

Critères de population

Sexe : Homme et femme
Age minimum : 18 ans
Critères d’inclusion :
  • Centrally confirmed HER2+ breast carcinoma per 2018 American Society of Clinical Oncologists (ASCO) College of American Pathologists (CAP) guidelines.

  • Have unresectable locally advanced or metastatic disease.

    • If recurrent (after [neo]adjuvant therapy), must be at least 6 month treatment free from any trastuzumab or pertuzumab received for advanced HER2+ disease.
  • Have received 4-8 cycles (21 day cycles) of previous treatment with trastuzumab, pertuzumab, and taxane as first-line therapy for advanced HER2+ breast cancer with no evidence of disease progression
  • Known hormone receptor status (per local guidelines; may be hormone receptor positive [HR+] or negative [HR-])
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

  • CNS Inclusion - Based on screening contrast brain magnetic resonance imaging (MRI), participants may have any of the following:

    • No evidence of brain metastases
    • Untreated brain metastases which are asymptomatic and, if identified on prior brain imaging, without evidence of progression since starting first-line induction therapy with trastuzumab, pertuzumab, and taxane

    • Previously treated brain metastases which are asymptomatic

      • Brain metastases previously treated with local therapy must not have progressed since treatment
Critères d’exclusion :
  • Prior treatment with any anti-HER2 and/or anti-epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib (except neratinib if given in extended adjuvant setting and ≥ 12 months have elapsed since last neratinib dose prior to start of study drug)
  • Unable to undergo contrast MRI of the brain

  • CNS Exclusion - Based on screening brain MRI and clinical assessment

    • Symptomatic brain metastasis
    • Progression of brain metastases since starting first line trastuzumab, pertuzumab, and taxane
    • Ongoing use of systemic corticosteroids at a total daily dose of >2 mg of dexamethasone (or equivalent)
    • Any untreated brain lesion in an anatomic site which may pose risk to participant
    • Known or suspected leptomeningeal disease (LMD)
    • Poorly controlled (>1/week) seizures, or other persistent neurologic symptoms

Centres d'investigation

En cours
Nom : Centre Georges François Leclerc - CGFL
Ville : DIJON (21)
RESPONSABLE MÉDICAL
Nom : Dr DESMOULINS
Prénom : Isabelle
Téléphone : Non disponible
Email : idesmoulins@cgfl.fr
CONTACT TECHNIQUE
Nom : BOTTE
Prénom : Anaïs
Téléphone : 03 80 73 77 56
Email : abotte@cgfl.fr
En cours
Nom : CHU de Besançon
Ville : BESANÇON (25)
RESPONSABLE MÉDICAL
Aucun responsable médical renseigné
CONTACT TECHNIQUE
Nom : BERTHOD
Prénom : Diane
Téléphone : 03 70 63 24 03
Email : dberthod@chu-besancon.fr
En cours
Nom : ICANS
Ville : Strasbourg
RESPONSABLE MÉDICAL
Aucun responsable médical renseigné
CONTACT TECHNIQUE
Nom : Unité recherche clinique
Prénom : ICANS
Téléphone : Non disponible
Email : recherche-clinique@icans.eu

Référentiels Oncologik

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