WHO ICTRP trial

Clinical trial to evaluate the feasibility of pegylated liposomal doxorubicin…

EUCTR2014-000842-30-IT · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2014-000842-30-IT
Public title Clinical trial to evaluate the feasibility of pegylated liposomal doxorubicin (Caelyx¿) in women operated for a breast cancer with estrogen receptors expression but either high proliferation rate, or low progesterone receptors expression, or overexpression of HER2.
Scientific title Caelyx¿ as Adjuvant Treatment in Early Stage Luminal B Breast Cancer: a feasibility Phase II Trial - Not applicable
Primary sponsor ISTITUTO EUROPEO DI ONCOLOGIA
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Italy
Conditions Operated breast cancer MedDRA version: 20.0 Level: LLT Classification code 10006190 Term: Breast cancer invasive NOS System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
Interventions Trade Name: CAELYX - 2 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO 10 ML USO EV Pharmaceutical Form: Concentrate for solution for infusion
Registration date Jan 26, 2021
Target size 63
Secondary IDs IEO62
Registry page clinicaltrialsregister.eu

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