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Spots Global Cancer Trial Database for EFficacy and Impact on Function of Two Different Doses of Nab-paclitaxEl in Elderly With advanCed breasT Cancer

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Trial Identification

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

Conditions

Breast Cancer

Interventions

Nab-paclitaxel

Study Description

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.

Eligibility

Minimum Age: 65 Years

Eligible Ages: OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Laura Biganzoli, MD

Affiliation: Azienda USL Toscana Centro - Prato

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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