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

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

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.

Study Overview

• Status: Terminated
• Conditions: Invasive Early Breast Cancer
• Intervention / Treatment: Drug: Aromasin

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 Type: Observational
• Enrollment (Actual): 378

Contacts and Locations

Study Locations

• Romania
  • Bacau, Romania, 600114
    • Spitalul Județean de Urgență Bacău
  • Bucharest, Romania, 50659
    • Policlinica Theodor Burghele, cabinet oncologie
  • Bucharest, Romania, 7000
    • Str. Povernei 42, Sector 1
  • Bucuresti, Romania, 022328
    • Institutul Oncologic "Prof. Dr. Al. Trestioreanu"
  • Bucuresti, Romania, 011794
    • CMDT MAPN Washington Ambulator oncologie
  • Bucuresti, Romania, 020142
    • Ambulator Spital Colentina, cabinet oncologie
  • Bucuresti, Romania, 020947
    • Cabinet Oncologie Medicala
  • Bucuresti, Romania, 021659
    • Ambulator Spital Sf. Pantelimon, cabinet oncolgie
  • Bucuresti, Romania, 030171
    • Ambulator Spital Clinic Colţea, cabinet oncologie
  • Bucuresti, Romania, 030442
    • Centru D.T. Titan Cabinet oncologie
  • Bucuresti, Romania, 042121
    • Policlinica Sf. Ioan Bucuresti, cabinet oncologie
  • Bucuresti, Romania, 7000
    • Ambulator Specialitate Cotroceni, cabinet oncolgie
  • Hunedoara, Romania, 331021
    • Spitalulul Judetean de Urgenta Deva, Ambulator oncologie medicala
  • Iasi, Romania, 700106
    • Spitalulul Clinic Judetean de Urgenta Sf. Spiridon, Ambulatoriu de specialitate adulti - Stationar o
  • Iasi, Romania, 700111
    • Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi Clinica Oncologie Medicala
  • Oradea, Romania, 410032
    • Spitalul clinic de urgenta
  • Sibiu, Romania, 550245
    • Spitalulul Clinic Judetean de Urgenta Sibiu- Sectia Oncologie medicala
  • Suceava, Romania, 720131
    • Spitalulul Judetean de Urgenta, Sf. Ioan cel Nou
  • Targu Jiu, Romania, 210140
    • Spitalul Judetean de Urgenta Targu Jiu, Ambulator Spital - Oncologie medicala
  • Arges
    • Pitesti, Arges, Romania, 110084
      • Policlinica Judeteana 1 Pitesti - Cabinet oncologie
  • Caras Severin
    • Resita, Caras Severin, Romania, 320076
      • Spitalul Judetean de Urgenta Resita Sectia oncologie medicala
  • Cluj
    • Cluj Napoca, Cluj, Romania, 40006
      • Spitalul Clinic Judetean de Urgenta Cluj, Clinica de Oncologie Medicala si Radioterapie
    • Cluj-Napoca, Cluj, Romania, 400015
      • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca
  • Covasna
    • Sfantu Gheorghe, Covasna, Romania, 520064
      • Spitalul Judetean Covasna, Sectia Oncologie medicala
  • Dambovita
    • Targoviste, Dambovita, Romania, 130095
      • Spitalul Judetean de Urgenta Targoviste
  • Jud. Bihor
    • Oradea, Jud. Bihor, Romania, 410167
      • Spital Clinic Judetean de Urgenta Oradea
  • Jud. Brasov
    • Brasov, Jud. Brasov, Romania, 505200
      • Spitalul Judetean Brasov
  • Jud. Galati
    • Galati, Jud. Galati, Romania, 800367
      • Spitalulul Judetean Clinic de Urgenta, Sf. Apostol Andrei
  • Jud. Nasaud
    • Bistrita, Jud. Nasaud, Romania, 420178
      • Spitalul Judetean Bistrita Nasaud - Sectia Oncologie Medicala
  • Jud. Sibiu
    • Sibiu, Jud. Sibiu, Romania, 550245
      • Spitalul Clinic Judetean de Urgenta Sibiu - Sectia Oncologie Medicala
  • Mehedinti
    • Drobeta Turnu Severin, Mehedinti, Romania, 220064
      • Spitalul Judetean Drobeta Turnu Severin - Sectie oncologie
  • Mures
    • Targu Mures, Mures, Romania, 540140
      • Spitalul Judetean Targu Mures
  • Neamt
    • Roman, Neamt, Romania, 617385
      • Spitalulul Municipal de Urgenta Roman
  • Olt
    • Slatina, Olt, Romania, 230008
      • Spitalul Judetean de Urgenta Slatina, Sectie oncologie
  • Prahova
    • Campina, Prahova, Romania, 107425
      • Spitalul Municipal Campina Sectia oncologie
    • Ploiesti, Prahova, Romania, 100337
      • Spitalul Municipal Ploiesti Sectia oncologie
  • Sibiu
    • Medias, Sibiu, Romania, 551026
      • Spitalul Municipal Medias Compartimentul Oncologie medicala
  • Timis
    • Timisoara, Timis, Romania, 300223
      • Spitalul Clinic Municipal de Urgenta Timisoara Clinica Oncologie Medicala
    • Timisoara, Timis, Romania, 300223
      • Spitalul Clinic Municipal Timisoara Sectia oncologie medicala
    • Timisoara, Timis, Romania, 300239
      • Oncomed SRL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal women hormone-receptor positive invasive with early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aromasin; All patients included in the study	Drug: Aromasin; 25 mg daily continuously; Other Names: exemestane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity	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).	Baseline up to 28 days after last dose
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) by Relationship to Study Drug	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.	Baseline up to 28 days after last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	Baseline up to Year 3
Time to Disease Progression (TTP)	Time to disease progression was defined as the time from inclusion to first local or distant recurrence at any site.	Baseline up to Year 3

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: March 30, 2010
• First Submitted That Met QC Criteria: May 11, 2010
• First Posted (Estimate): May 12, 2010

Study Record Updates

• Last Update Posted (Estimate): January 22, 2014
• Last Update Submitted That Met QC Criteria: December 4, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: NIS; tamoxifen; postmenopausal; Prospective; non-comparative; 600; hormone-receptor; positive; EBC; current medical practice.
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Exemestane
• Other Study ID Numbers: A5991091