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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01121549
First received: March 30, 2010
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Invasive Early Breast Cancer
Drug: Aromasin

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity [ Time Frame: Baseline up to 28 days after last dose ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline up to 28 days after last dose ] [ Designated as safety issue: Yes ]
    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:
  • Number of Missed Exemestane Doses [ Time Frame: Week 25, 49, 73, 97, 121, 145 ] [ Designated as safety issue: No ]
  • Number of Participants With Reasons for Discontinuing Exemestane Therapy [ Time Frame: Baseline up to Year 3 ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Received Hormonal Therapy or Chemotherapy After Discontinuation of Exemestane Therapy [ Time Frame: Baseline up to Year 3 ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Discontinued the Exemestane Therapy [ Time Frame: Baseline up to Year 3 ] [ Designated as safety issue: Yes ]
  • Recurrence-free Survival (RFS) [ Time Frame: Baseline up to Year 3 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline up to Year 3 ] [ Designated as safety issue: No ]
    Time to disease progression was defined as the time from inclusion to first local or distant recurrence at any site.


Enrollment: 378
Study Start Date: February 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Aromasin
All patients included in the study
Drug: Aromasin
25 mg daily continuously
Other Name: exemestane

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121549

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01121549     History of Changes
Other Study ID Numbers: A5991091
Study First Received: March 30, 2010
Results First Received: December 4, 2013
Last Updated: December 4, 2013
Health Authority: Romania: Romanian National Medicine Agency

Keywords provided by Pfizer:
Prospective
non-comparative
NIS
600
postmenopausal
hormone-receptor
positive
EBC
tamoxifen
current medical practice.

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Exemestane
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014