Spots Global Cancer Trial Database for Maintenance Aromatase Inhibitors (AIs)+ Everolimus vs AIs in Hormone Receptor Positive Metastatic Breast Cancer Patients
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Trial Identification
Brief Title: Maintenance Aromatase Inhibitors (AIs)+ Everolimus vs AIs in Hormone Receptor Positive Metastatic Breast Cancer Patients
Official Title: MAINtenance Afinitor: A Randomized Trial Comparing Maintenance Aromatase Inhibitors (AIs) + Everolimus (Afinitor) vs AIs in Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients With Disease Control After First Line Chemotherapy
Study ID: NCT02511639
Conditions
Study Description
Brief Summary: The purpose of this study is to compare maintenance Aromatase Inhibitors (AIs) + everolimus with Aromatase Inhibitors alone after 1st line chemotherapy in patients with HR+ metastatic breast cancer.
Detailed Description: The purpose of this study is: * to compare the progression free survival (PFS) of AIs/everolimus to AIs administered as maintenance therapy in HR+ advanced breast cancer patients with disease control (Complete Response (CR), Partial Response (PR) or Stable Disease (SD))after 1st line chemotherapy. * To evaluate the overall survival * To assess the safety profile * To evaluate the response rate
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona, Ancona, AN, Italy
Ospedale Papa Giovanni XXIII, Bergamo, Bg, Italy
Policlinico Sant'Orsola Malpighi, Bologna, BO, Italy
ASL Brindisi "Antonio Perrini", Brindisi, BR, Italy
Azienda Spedali Civili di Brescia, Brescia, BS, Italy
A.S.O. S.Croce e Carle di Cuneo, Cuneo, CN, Italy
Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele", Catania, CT, Italy
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna, Cona, FE, Italy
Ospedale Misericordia di Grosseto, Grosseto, GR, Italy
Istituto Nazionale dei Tumori IRCCS, Milano, MI, Italy
Azienda Ospedaliera Universitaria di Parma, Parma, PR, Italy
IRCCS - Azienda Ospedaliera S.M. Nuova, Reggio Emilia, RE, Italy
Ospedale Civile Santa Chiara, Trento, TN, Italy
Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia", Udine, UD, Italy
Ospedale Sacro Cuore - Don Calabria, Negrar, VR, Italy
Ospedale dell'Angelo, Mestre, , Italy
Contact Details
Name: Pierfranco Conte, MD, PhD
Affiliation: Medical Oncology 2, Istituto Oncologico Veneto
Role: PRINCIPAL_INVESTIGATOR
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