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

Terminated

• Conditions: Invasive Early Breast Cancer
• Interventions: Drug: Aromasin

• Registration Number: NCT01121549
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-30
• Study First Submitted QC: 2010-05-11
• Study First Posted: 2010-05-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-12
• Results First Submitted: 2013-12-04
• Results First Submitted QC: 2013-12-04
• Last Update Submitted: 2013-12-04
• Results First Posted: 2014-01-22
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 378

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aromasin	Aromasin	All patients included in the study

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity	Baseline up to 28 days after last dose	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs were graded using National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE,v4.0) as Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention; limiting age-appropriate instrumental activities of daily living \[ADL\]); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization; disabling; limiting self-care ADL); Grade 4 (Life-threatening; urgent intervention indicated) and Grade 5 (Death related to AE).
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) by Relationship to Study Drug	Baseline up to 28 days after last dose	An AE (all causalities) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to exemestane was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

Secondary Outcome Measures

Name	Time	Method
Number of Missed Exemestane Doses	Week 25, 49, 73, 97, 121, 145
Number of Participants With Reasons for Discontinuing Exemestane Therapy	Baseline up to Year 3
Number of Participants Who Received Hormonal Therapy or Chemotherapy After Discontinuation of Exemestane Therapy	Baseline up to Year 3
Percentage of Participants Who Discontinued the Exemestane Therapy	Baseline up to Year 3
Recurrence-free Survival (RFS)	Baseline up to Year 3	Recurrence-free survival defined as the time from study inclusion to the first date of documented recurrence, with events defined as: local recurrence, distant recurrence, new primary breast cancer (includes both ipsilateral and contralateral second primaries), or death due to any cause. New primary cancer at sites other than the breast were not considered as recurrence.
Time to Disease Progression (TTP)	Baseline up to Year 3	Time to disease progression was defined as the time from inclusion to first local or distant recurrence at any site.

Trial Locations

Locations (40)

Spitalul Judeţean Brasov; 🇷🇴 Brasov, Jud. Brasov, Romania

Spitalul Judetean Bistrita Nasaud - Sectia Oncologie Medicala; 🇷🇴 Bistrita, Jud. Nasaud, 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 Clinic Municipal de Urgenta Timisoara Clinica Oncologie Medicala; 🇷🇴 Timisoara, Timis, Romania

Spitalul Clinic Municipal Timisoara Sectia oncologie medicala; 🇷🇴 Timisoara, Timis, Romania

Spitalul Judetean de Urgenta Bacau; 🇷🇴 Bacau, Romania

Policlinica Theodor Burghele, cabinet oncologie; 🇷🇴 Bucharest, Romania

Cabinet Oncologie Medicala; 🇷🇴 Bucuresti, Romania

Institutul Oncologic "Prof. Dr. Al. Trestioreanu"; 🇷🇴 Bucuresti, Romania

Policlinica Sf. Ioan Bucuresti, cabinet oncologie; 🇷🇴 Bucuresti, Romania

Ambulator Specialitate Cotroceni, cabinet oncolgie; 🇷🇴 Bucuresti, Romania

Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi Clinica Oncologie Medicala; 🇷🇴 Iasi, 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

Spitalul Judetean de Urgenta Resita Sectia oncologie medicala; 🇷🇴 Resita, Caras Severin, Romania

Spital Clinic Judetean de Urgenta Oradea; 🇷🇴 Oradea, Jud. Bihor, 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 de Urgenta Targoviste; 🇷🇴 Targoviste, Dambovita, Romania

Str. Povernei 42, Sector 1; 🇷🇴 Bucharest, Romania

Spitalul Clinic de Urgenta; 🇷🇴 Oradea, Romania

Oncomed Srl; 🇷🇴 Timisoara, Timis, Romania

CMDT MAPN Washington Ambulator oncologie; 🇷🇴 Bucuresti, Romania

Centru D.T. Titan Cabinet oncologie; 🇷🇴 Bucuresti, Romania

Spitalulul Judetean Clinic de Urgenta, Sf. Apostol Andrei; 🇷🇴 Galati, Jud. Galati, Romania

Spitalulul Judetean de Urgenta Deva, Ambulator oncologie medicala; 🇷🇴 Hunedoara, Romania

Spitalul Judetean Drobeta Turnu Severin - Sectie oncologie; 🇷🇴 Drobeta Turnu Severin, Mehedinti, Romania

Spitalul Municipal Ploiesti Sectia oncologie; 🇷🇴 Ploiesti, Prahova, Romania

Policlinica Judeteana 1 Pitesti - Cabinet oncologie; 🇷🇴 Pitesti, Arges, Romania

Spitalul Judetean Covasna, Sectia Oncologie medicala; 🇷🇴 Sfantu Gheorghe, Covasna, Romania

Spitalul Clinic Judetean de Urgenta Sibiu - Sectia Oncologie Medicala; 🇷🇴 Sibiu, Jud. Sibiu, Romania

Spitalul Judetean Targu Mures; 🇷🇴 Targu Mures, Mures, Romania

Spitalul Municipal Medias Compartimentul Oncologie medicala; 🇷🇴 Medias, Sibiu, Romania

Ambulator Spital Colentina, cabinet oncologie; 🇷🇴 Bucuresti, Romania

Ambulator Spital Sf. Pantelimon, cabinet oncolgie; 🇷🇴 Bucuresti, Romania

Ambulator Spital Clinic Colţea, cabinet oncologie; 🇷🇴 Bucuresti, Romania

Spitalulul Clinic Judetean de Urgenta Sf. Spiridon, Ambulatoriu de specialitate adulti - Stationar o; 🇷🇴 Iasi, Romania