WHO ICTRP trial

Study comparing two standard treatments as initial metastatic treatment among…

CTIS2024-513005-31-00 · EU Clinical Trials Information System · Not Recruiting

Key facts

Trial ID CTIS2024-513005-31-00
Public title Study comparing two standard treatments as initial metastatic treatment among patients with visceral metastasis of ER+ HER2- breast cancer, high burden disease: chemotherapy and combination of hormonotherapy with abemaciclib.
Scientific title AMBRE : Open-label, randomized, multicenter, phase III study, comparing standard chemotherapy to standard combination of endocrine therapy with Abemaciclib as initial Metastatic treatment among patients with visceral metastasis of ER+ HER2- BREast cancer, high burden disease. - UC-0140/1901
Primary sponsor Unicancer
Registry EU Clinical Trials Information System
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): No Therapeutic exploratory (Phase II): No Therapeutic confirmatory - (Phase III): Yes Therapeutic use - (Phase IV): No
Countries France
Conditions Patients with untreated metastatic Estrogen Receptor positive (ER+), Human Epidermal Growth Factor Receptor-2 negative (HER2-) breast cancer with visceral involvement MedDRA version: 27.0Level: LLTClassification code: 10027475Term…
Interventions Product Name: PACLITAXEL, Product Code:SUB09583MIG, Pharmaceutical Form: CONCENTRATE FOR SOLUTION FOR INFUSION, Other descriptive name: , Strength: , Product Name: CAPECITABINE, Product Code:SUB12474MIG, Pharmaceutical Form: FILM COATED…
Registration date Sep 8, 2024
Target size 180
Secondary IDs NCT04158362;2019-000260-14
Registry page euclinicaltrials.eu

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