A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer

NCT ID: NCT01121549

Last Updated: 2014-01-22

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 378 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-12-31

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.

Conditions

Invasive Early Breast Cancer

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Aromasin

All patients included in the study

Aromasin

Intervention Type: DRUG

25 mg daily continuously

Interventions

Aromasin

25 mg daily continuously

Intervention Type: DRUG

Other Intervention Names

exemestane

Eligibility Criteria

Inclusion Criteria

• Postmenopausal females, defined as one from the next :

1. Natural menopause >/=1 year,

2. Surgical ovariectomy,

3. Chemotherapy-induced amenorrhoea >/=2 years.

• Patients who have had surgical treatment for histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
• Patients who are disease-free after 2 or 3 years of adjuvant tamoxifen treatment.
• Patients whose tumour was estrogen receptor positive (ER+).
• Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria

• Patients for whom Aromasin® treatment is contraindicated (see SmPC).
• Presence of metastasis or a contra lateral tumour.
• Other adjuvant endocrine therapy.
• Another concomitant antineoplastic treatment
• Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.
• The patients are not supposed to participate to any other trial during all the study period.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Policlinica Judeteana 1 Pitesti - Cabinet oncologie

PiteÅŸti, ArgeÅŸ, Romania

Spitalul Judetean de Urgenta Bacau

Bacau, Bacău, Romania

CMDT MAPN Washington Ambulator oncologie

Bucharest, București, Romania

Centru D.T. Titan Cabinet oncologie

Bucharest, București, Romania

Spitalul Judetean de Urgenta Resita Sectia oncologie medicala

Reşiţa, Caraș-Severin County, Romania

Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca

Cluj-Napoca, Cluj, Romania

Spitalul Clinic Judetean de Urgenta Cluj, Clinica de Oncologie Medicala si Radioterapie

Cluj-Napoca, Cluj, Romania

Spitalul Judetean Covasna, Sectia Oncologie medicala

Sfântu Gheorghe, Covasna, Romania

Spitalul Judetean de Urgenta Targoviste

Târgovişte, Dâmbovița County, Romania

Spitalulul Judetean de Urgenta Deva, Ambulator oncologie medicala

Hunedoara, Hunedoara County, Romania

Spitalulul Clinic Judetean de Urgenta Sf. Spiridon, Ambulatoriu de specialitate adulti - Stationar o

Iași, Iaşi, Romania

Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi Clinica Oncologie Medicala

Iași, Iaşi, 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

Bistriţa, 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, Mehedinți County, Romania

Spitalul Judetean Targu Mures

Târgu Mureş, Mureș County, Romania

Spitalulul Municipal de Urgenta Roman

Roman, NeamÈ› County, Romania

Spitalul Judetean de Urgenta Slatina, Sectie oncologie

Slatina, Olt, Romania

Spitalul Municipal Campina Sectia oncologie

Câmpina, Prahova, Romania

Spitalul Municipal Ploiesti Sectia oncologie

PloieÅŸti, Prahova, Romania

Spitalul Municipal Medias Compartimentul Oncologie medicala

MediaÅŸ, Sibiu County, Romania

Spitalulul Clinic Judetean de Urgenta Sibiu- Sectia Oncologie medicala

Sibiu, Sibiu County, Romania

Spitalulul Judetean de Urgenta, Sf. Ioan cel Nou

Suceava, Suceava, Romania

Spitalul Clinic Municipal de Urgenta Timisoara Clinica Oncologie Medicala

Timișoara, Timiș County, Romania

Spitalul Clinic Municipal Timisoara Sectia oncologie medicala

Timișoara, Timiș County, Romania

Oncomed Srl

Timișoara, Timiș County, Romania

Ambulator Spital Colentina, cabinet oncologie

Bucharest, , Romania

Cabinet Oncologie Medicala

Bucharest, , Romania

Ambulator Spital Sf. Pantelimon, cabinet oncolgie

Bucharest, , Romania

Institutul Oncologic "Prof. Dr. Al. Trestioreanu"

Bucharest, , Romania

Ambulator Spital Clinic Colţea, cabinet oncologie

Bucharest, , Romania

Policlinica Sf. Ioan Bucuresti, cabinet oncologie

Bucharest, , Romania

Policlinica Theodor Burghele, cabinet oncologie

Bucharest, , Romania

Ambulator Specialitate Cotroceni, cabinet oncolgie

Bucharest, , Romania

Str. Povernei 42, Sector 1

Bucharest, , Romania

Spitalul Clinic de Urgenta

Oradea, , Romania

Spitalul Judetean de Urgenta Targu Jiu, Ambulator Spital - Oncologie medicala

Târgu Jiu, , Romania

Countries

Romania

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5991091&StudyName=A%20Non-Interventional%20Study%20With%20Aromasin%AE%20As%20Adjuvant%20Treatment%20Of%20Invasive%20Early%20Breast%20Cancer%20

To obtain contact information for a study center near you, click here.

Other Identifiers

A5991091

Identifier Type: -

Identifier Source: org_study_id