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Brief Title: Ribociclib-endocrine Combination Therapy Versus Chemotherapy as 1st Line in Visceral mBC
Official Title: Ribociclib-endocrine Combination Therapy Versus Chemotherapy as 1st Line Treatment in Patients With Visceral Metastatic Breast Cancer. A Multicenter, Randomized Phase III Trial.
Study ID: NCT03905343
Brief Summary: The aim of this trial is to assess if patients treated with the combination of ribociclib and endocrine therapy respond to treatment as fast as patients treated with chemotherapy only, without decreasing their quality of life (QoL).
Detailed Description: Breast cancer is the most frequent malignancy in women and the leading cause of cancer mortality in most countries in Europe. Metastatic breast cancer remains an incurable disease with a median overall survival (OS) of 2-4 years and a 5-year survival of only 25%. Patients with hormone receptor (HR)-positive breast cancer involving visceral disease at diagnosis have an even worse outcome. Many oncologists still prefer to treat visceral disease primarily with chemotherapy rather than with endocrine treatment, thinking to receive a faster response with chemotherapy than with endocrine therapy, especially in patients with clinical symptoms or potentially threatening lesions. However, results from cross-sectional clinical practice studies suggest that endocrine therapy is associated with better quality of life, fewer concerns about side effects, less activity impairment and higher treatment satisfaction compared to chemotherapy. In addition, with the new data of CDK4/6 inhibitors combined with endocrine treatment there is an even better efficacy data available compared to endocrine therapy alone. The aim of this trial is to assess if patients treated with the combination of ribociclib and endocrine therapy respond to treatment as fast as patients treated with chemotherapy only, without decreasing their quality of life (QoL).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Med. Univ. Klinik Graz, Graz, , Austria
Tirol Kliniken - BrustGesundheitZentrum Tirol, Innsbruck, , Austria
Salzburger Landeskliniken - Universitätsklinikum Salzburg, Salzburg, , Austria
Universitätsklinik für Frauenheilkunde, Wien, , Austria
Algemeen Ziekenhuis Klina, Brasschaat, , Belgium
Grand Hôpital de Charleroi, Charleroi, , Belgium
Jessa Ziekenhuis, Hasselt, , Belgium
CHC Mont Légia, Liège, , Belgium
CHU de Liege, Liège, , Belgium
CHR de la Citadelle, Liége, , Belgium
CHU UCL Namur - Site Sainte Elisabeth, Namur, , Belgium
Clinique-Saint-Pierre, Ottignies, , Belgium
Kantonsspital Baden, Baden, , Switzerland
Kantonsspital Baden, Baden, , Switzerland
Universitaetsspital-Basel, Basel, , Switzerland
Brustzentrum Basel - Praxis für ambulante Tumortherapie, Basel, , Switzerland
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli, Bellinzona, , Switzerland
Inselspital Bern, Bern, , Switzerland
Kantonsspital Graubuenden, Chur, , Switzerland
Clinique des Grangettes, Chêne-Bougeries, , Switzerland
Hôpital neuchâtelois, La Chaux-de-Fonds, , Switzerland
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Kantonsspital Liestal, Liestal, , Switzerland
Kantonsspital Luzern, Luzern, , Switzerland
Hirslanden Klinik St. Anna Luzern, Luzern, , Switzerland
Onkologie Zentrum Spital Männedorf, Männedorf, , Switzerland
Kantonsspital Olten, Olten, , Switzerland
Hôpital de Sion, Sion, , Switzerland
Brustzentrum Ostschweiz, St. Gallen, , Switzerland
Kantonsspital - St. Gallen, St. Gallen, , Switzerland
Spital STS AG, Thun, , Switzerland
Kantonsspital Winterthur, Brustzentrum, Winterthur, , Switzerland
Onkologie Bellevue, Zurich, , Switzerland
OnkoZentrum Zürich AG - Klinik im Park, Zürich, , Switzerland
Universitäts Spital Zürich, Zürich, , Switzerland
Name: Thomas Ruhstaller, Prof
Affiliation: Kantonsspital St. Gallen - Breast Center St. Gallen
Role: STUDY_CHAIR