Spots Global Cancer Trial Database for A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer
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Trial Identification
Brief Title: A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer
Official Title: A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer In Postmenopausal Hormone Receptors Positive Patients Following Of 2-3 Years of Initial Adjuvant Tamoxifen Therapy
Study ID: NCT01121549
Conditions
Interventions
Study Description
Brief Summary: The IES study (A5991012) investigated 4742 patients treated for 2 to 3 years with tamoxifen, who either continued the same treatment or switched to Aromasin® for a total treatment period of 5 years. Only 65 Romanian patients were enrolled in the IES study. It would therefore appear to be essential to evaluate and confirm the tolerability of Aromasin® and the ways in which it is used on a broader sample of patients and under the standard conditions of use as stipulated in the MA. This Non-Interventional study was designed to address these issues.
Detailed Description: This is a prospective, non-comparative, non interventional study (NIS) in four hundred (400) postmenopausal women hormone-receptor positive invasive with early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy conducted in 60 sites from Romania according to protocol A5991091.The selection of patients based on diagnosis, the attribution of medicinal products and the follow-up of the subjects fall within the current medical practice. A Non-Interventional study is primarily observational in nature. The present Non-interventional Study is performed by medical oncologist and medical oncologist /radiation oncologist who agree to take part in this project. n/a The study was prematurely terminated on August 31th 2012 due to unexpected high rate of patient withdrawal caused by Aromasin reimbursement policy change in Romania; There were no safety issues related to study termination.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Policlinica Judeteana 1 Pitesti - Cabinet oncologie, Pitesti, Arges, Romania
Spitalul Judetean de Urgenta Resita Sectia oncologie medicala, Resita, Caras Severin, Romania
Spitalul Clinic Judetean de Urgenta Cluj, Clinica de Oncologie Medicala si Radioterapie, Cluj Napoca, Cluj, Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca, Cluj-Napoca, Cluj, Romania
Spitalul Judetean Covasna, Sectia Oncologie medicala, Sfantu Gheorghe, Covasna, Romania
Spitalul Judetean de Urgenta Targoviste, Targoviste, Dambovita, Romania
Spital Clinic Judetean de Urgenta Oradea, Oradea, Jud. Bihor, Romania
Spitalul Judeţean Brasov, Brasov, Jud. Brasov, Romania
Spitalulul Judetean Clinic de Urgenta, Sf. Apostol Andrei, Galati, Jud. Galati, Romania
Spitalul Judetean Bistrita Nasaud - Sectia Oncologie Medicala, Bistrita, Jud. Nasaud, Romania
Spitalul Clinic Judetean de Urgenta Sibiu - Sectia Oncologie Medicala, Sibiu, Jud. Sibiu, Romania
Spitalul Judetean Drobeta Turnu Severin - Sectie oncologie, Drobeta Turnu Severin, Mehedinti, Romania
Spitalul Judetean Targu Mures, Targu Mures, Mures, Romania
Spitalulul Municipal de Urgenta Roman, Roman, Neamt, Romania
Spitalul Judetean de Urgenta Slatina, Sectie oncologie, Slatina, Olt, Romania
Spitalul Municipal Campina Sectia oncologie, Campina, Prahova, Romania
Spitalul Municipal Ploiesti Sectia oncologie, Ploiesti, Prahova, Romania
Spitalul Municipal Medias Compartimentul Oncologie medicala, Medias, Sibiu, Romania
Spitalul Clinic Municipal de Urgenta Timisoara Clinica Oncologie Medicala, Timisoara, Timis, Romania
Spitalul Clinic Municipal Timisoara Sectia oncologie medicala, Timisoara, Timis, Romania
Oncomed Srl, Timisoara, Timis, Romania
Spitalul Judetean de Urgenta Bacau, Bacau, , Romania
Policlinica Theodor Burghele, cabinet oncologie, Bucharest, , Romania
Str. Povernei 42, Sector 1, Bucharest, , Romania
CMDT MAPN Washington Ambulator oncologie, Bucuresti, , Romania
Ambulator Spital Colentina, cabinet oncologie, Bucuresti, , Romania
Cabinet Oncologie Medicala, Bucuresti, , Romania
Ambulator Spital Sf. Pantelimon, cabinet oncolgie, Bucuresti, , Romania
Institutul Oncologic "Prof. Dr. Al. Trestioreanu", Bucuresti, , Romania
Ambulator Spital Clinic Colţea, cabinet oncologie, Bucuresti, , Romania
Centru D.T. Titan Cabinet oncologie, Bucuresti, , Romania
Policlinica Sf. Ioan Bucuresti, cabinet oncologie, Bucuresti, , Romania
Ambulator Specialitate Cotroceni, cabinet oncolgie, Bucuresti, , Romania
Spitalulul Judetean de Urgenta Deva, Ambulator oncologie medicala, Hunedoara, , Romania
Spitalulul Clinic Judetean de Urgenta Sf. Spiridon, Ambulatoriu de specialitate adulti - Stationar o, Iasi, , Romania
Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi Clinica Oncologie Medicala, Iasi, , Romania
Spitalul Clinic de Urgenta, Oradea, , Romania
Spitalulul Clinic Judetean de Urgenta Sibiu- Sectia Oncologie medicala, Sibiu, , Romania
Spitalulul Judetean de Urgenta, Sf. Ioan cel Nou, Suceava, , Romania
Spitalul Judetean de Urgenta Targu Jiu, Ambulator Spital - Oncologie medicala, Targu Jiu, , Romania
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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