Etude : eMonarcHER /



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


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

Situation thérapeutique : Adjuvant

Traitement : Thérapie ciblée

Cadre réglementaire : RIPH1

Dernière MÀJ : 01/12/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib plus Standard Adjuvant Endocrine Therapy in Participants with High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy

Spécialité : Seins, organes génitaux de la femme
Localisation : C50 - Tumeur maligne du sein
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery. Participants must have breast cancer that is hormone receptor positive (HR+) and human epidermal receptor 2 positive (HER2+). Your participation could last up to 10 years depending on how you and your tumor respond.

2 arms:
- Experimental: Abemaciclib Plus (+) Endocrine Therapy (ET)
Abemaciclib administered orally and standard adjuvant ET (physician's choice) administered according to package label.
- Active Comparator: Placebo + ET
Placebo administered orally and standard adjuvant ET (physician's choice) administered according to package label.

Phase : III

Stade : Localisé à Localement avancé

NA
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 : - Have confirmed HR+, HER2+ in initial diagnostic tissue, early invasive breast cancer without evidence of disease recurrence or distant metastases
- Have undergone definitive surgery of the primary breast tumor(s)
- Have tumor tissue from breast (preferred) or lymph node
- Have received a minimum of four cycles of chemotherapy in either the neoadjuvant or adjuvant setting per standard of care therapy
- Have completed approximately nine months to one year of standard HER2-targeted therapy without evidence of disease recurrence (neoadjuvant/adjuvant combined duration)
- Have received one of the following eligible HER2-targeted adjuvant regimens AND be randomized within 12 weeks of completing the regimen:
-> For participants treated with neoadjuvant therapy (chemotherapy administered with HER2-targeted therapy): Single agent adjuvant ado-trastuzumab emtansine or
-> For participants not treated with neoadjuvant therapy: Adjuvant pertuzumab with trastuzumab
- Have high risk disease, defined by one of the following:
-> For participants treated with neoadjuvant therapy (as defined above): Pathologically detected axillary nodal disease in the surgical specimen
-> For participants not treated with neoadjuvant therapy: Axillary node positive disease meeting one of the following criteria:
* Pathological tumor involvement in greater than or equal to (≥) four ipsilateral axillary lymph nodes OR
* Pathological tumor involvement in one to three ipsilateral axillary lymph node(s) and at least 1 of the following criteria:
- Histological Grade 3
- Primary invasive tumor size ≥5 centimeters determined pathologically

Critères de non-inclusion : - Have breast cancer with any of the following features:
-> Disease recurrence or distant metastatic disease (including contralateral axillary lymph nodes)
-> Lymph node-negative status
-> Pathological complete response from any prior systemic treatments for early breast cancer
-> Inflammatory breast cancer
- Have other medical conditions including:
-> Previous breast cancer (Exceptions: Ipsilateral ductal carcinoma in situ [DCIS] treated by locoregional therapy alone ≥5 years ago; contralateral DCIS treated by locoregional therapy at any time)
-> Other cancer being treated and/or not in complete remission within the last 5 years (Exceptions: Appropriately treated non-melanomatous skin cancer or carcinoma in situ of cervix, bladder, or colon)
-> Females who are pregnant or lactating
-> History of venous thromboembolism
-> Other serious medical conditions
- Have previously received treatment with:
-> Any cyclin-dependent kinase (CDK)4 and CDK6 inhibitor
-> Prior adjuvant treatment with immunotherapy, tucatinib, neratinib, investigational HER2 directed therapy, or trastuzumab deruxtecan for treatment of breast cancer
-> Endocrine therapy (ET) (i.e., tamoxifen, raloxifene or aromatase inhibitor) for breast cancer prevention (without diagnosis of breast cancer)
-> Additional chemotherapy, anti-cancer ET, or HER2-targeted therapy beyond standard of care therapy for their breast cancer at study enrollment
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04752332
Promoteur :
Eli Lilly and Company
Type de sponsor : Industriel
Eli Lilly and Company
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
Apicrypt : essaitherapeutiquecfb@baclesse.unicancer.fr

Investigateur :
Christelle LEVY

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

Statut de l'essai : OUVERT

MAJ : 04/11/2021