Etude : MONARCHE /



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

Nom :

Traitement : Adjuvant

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 31/05/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone in Patients with High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer

Spécialité : Seins, organes génitaux de la femme
Localisation : C50 - Tumeur maligne du sein
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma :

Phase : III

Stade : Localisé à Localement avancé

NA
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Women (regardless of menopausal status) or men ≥18 years of age (or per local regulations).
- The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases.
- The participant must have undergone definitive surgical treatment for the current malignancy.
- The participant must have tumor tissue from breast (preferred) or lymph node for exploratory biomarker analysis available prior to randomization.
- The participant must have axillary lymph node involvement by tumor and have one of the following indicating a higher risk of relapse:
4 or more axillary lymph nodes involved with cancer
Tumor size of at least 5 centimeters
Grade 3 histology
Ki67 index by central analysis of ≥20% on untreated breast tissue
- The participant must be randomized within 16 months from the time of surgery.
- If the participant is currently receiving or initiating standard adjuvant endocrine therapy at time of study entry, she/he must not have received more than 12 weeks of adjuvant endocrine therapy following his/her last non-endocrine therapy (surgery, chemotherapy, or radiation).
- Participants must have recovered from the acute effects of chemotherapy and radiotherapy and from surgical side effects following definitive breast surgery.
- Women of reproductive potential must have a negative blood pregnancy test and agree to use highly effective contraceptive methods.
- The participant has a Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- The participant has adequate organ function.
- The participant is able to swallow oral medications.

Critères de non-inclusion : - Stage IV (M1), Stage IA, and lymph node negative breast cancer.
- Participants with a history of previous breast cancer are excluded, with the exception of lobular carcinoma in situ (LCIS) or ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago. Participants with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years are excluded.
- Females who are pregnant or lactating.
- The participant has previously received treatment with any CDK4 and CDK6 inhibitor.
- The participant is receiving concurrent exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate).
- The participant has previously received endocrine therapy for breast cancer prevention (tamoxifen or raloxifene or aromatase inhibitors).
- The participant has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
- The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin or sudden cardiac arrest. Any participant with a history of venous thromboembolism (VTE) (for example, deep vein thrombosis [DVT] of the leg or arm and/or pulmonary embolism) will be excluded.
- The participant has active bacterial infection, fungal infection, or detectable viral infection or viral load.
- The participant has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
Promoteur :
LILLY
Type de sponsor : Industriel
LILLY - LILLY
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Henri Becquerel - Rue d'Amiens CS 11516 - Cedex 1 - 76000 ROUEN

Investigateur :
Cristian MOLDOVAN

TEC / ARC / IDE :
Delphine BRIDELANCE
delphine.bridelance@
chb.unicancer.fr

Ouverture de l'essai : CLOS

MAJ : 31/05/2019