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Brief Title: EFficacy and Impact on Function of Two Different Doses of Nab-paclitaxEl in Elderly With advanCed breasT Cancer
Official Title: EFFECT: A Randomized Phase II Study to Evaluate the EFficacy and Impact on Function of Two Different Doses of Nab-paclitaxEl in Elderly Patients With advanCed breasT Cancer
Study ID: NCT02783222
Brief Summary: This is a randomized study evaluating the efficacy and impact on function of two different doses of nab-Paclitaxel in elderly patients with advanced breast cancer.
Detailed Description: This open-label, randomized phase II trial evaluates in parallel two doses of nab-Paclitaxel (100 and 125mg/m2) given weekly for 3 weeks every 28 days, in elderly women aged 65 years or older, as first line treatment for advanced breast cancer (locally recurrent or metastatic). A short geriatric evaluation of co-morbidity and functional status will be performed before study entry. The functional status will be monitored at baseline and at every cycles during treatment.
Minimum Age: 65 Years
Eligible Ages: OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
A.O.U. Ospedali Riuniti, Ancona, , Italy
Centro Di Riferimento Oncologico, Aviano, , Italy
Azienda Ospedaliera Papa Giovanni Xxiii, Bergamo, , Italy
Spedali Civili Brescia, Brescia, , Italy
Ospedale Antonio Perrino, Brindisi, , Italy
Ospedale Ss. Trinita', Frosinone, , Italy
Ospedale Vito Fazzi, Lecce, , Italy
Ausl 12 Viareggio, Lucca, , Italy
Istituto Europeo Oncologia, Milano, , Italy
A.O.U. Federico Ii Di Napoli, Napoli, , Italy
Istituto Oncologico Veneto, Padova, , Italy
Fondazione Maugeri, Pavia, , Italy
A.O.U. S. Maria Della Misericordia Di Udine, Udine, , Italy
Ospedale Civile Maggiore, Verona, , Italy
Name: Laura Biganzoli, MD
Affiliation: Azienda USL Toscana Centro - Prato
Role: PRINCIPAL_INVESTIGATOR