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

NCT01121549 | Terminated Results

• 1 other identifier: A5991091
• Study Type: observational
• Target: 378
• Locations: 1 country
• Sites: 40

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.

Conditions

Invasive Early Breast Cancer

Keywords

Prospective; non-comparative; NIS; 600; postmenopausal; hormone-receptor; positive; EBC; tamoxifen; current medical practice.

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (1)

Aromasin

All patients included in the study

Drug: Aromasin

Interventions

Aromasin DRUG

25 mg daily continuously

Also known as: exemestane

Aromasin

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Postmenopausal females, defined as one from the next :
• Natural menopause \>/=1 year,
• Surgical ovariectomy,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (40)

Policlinica Judeteana 1 Pitesti - Cabinet oncologie

Piteşti, Argeş, 110084, Romania

Location

Spitalul Judetean de Urgenta Bacau

Bacau, Bacău, 600114, Romania

Location

CMDT MAPN Washington Ambulator oncologie

Bucharest, București, 011794, Romania

Location

Centru D.T. Titan Cabinet oncologie

Bucharest, București, 030442, Romania

Location

Spitalul Judetean de Urgenta Resita Sectia oncologie medicala

Reşiţa, Caraș-Severin County, 320076, Romania

Location

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

Cluj-Napoca, Cluj, 400015, Romania

Location

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

Cluj-Napoca, Cluj, 40006, Romania

Location

Spitalul Judetean Covasna, Sectia Oncologie medicala

Sfântu Gheorghe, Covasna, 520064, Romania

Location

Spitalul Judetean de Urgenta Targoviste

Târgovişte, Dâmbovița County, 130095, Romania

Location

Spitalulul Judetean de Urgenta Deva, Ambulator oncologie medicala

Hunedoara, Hunedoara County, 331021, Romania

Location

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

Iași, Iaşi, 700106, Romania

Location

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

Iași, Iaşi, 700111, Romania

Location

Spital Clinic Judetean de Urgenta Oradea

Oradea, Jud. Bihor, 410167, Romania

Location

Spitalul Judeţean Brasov

Brasov, Jud. Brasov, 505200, Romania

Location

Spitalulul Judetean Clinic de Urgenta, Sf. Apostol Andrei

Galati, Jud. Galati, 800367, Romania

Location

Spitalul Judetean Bistrita Nasaud - Sectia Oncologie Medicala

Bistriţa, Jud. Nasaud, 420178, Romania

Location

Spitalul Clinic Judetean de Urgenta Sibiu - Sectia Oncologie Medicala

Sibiu, Jud. Sibiu, 550245, Romania

Location

Spitalul Judetean Drobeta Turnu Severin - Sectie oncologie

Drobeta-Turnu Severin, Mehedinți County, 220064, Romania

Location

Spitalul Judetean Targu Mures

Târgu Mureş, Mureș County, 540140, Romania

Location

Spitalulul Municipal de Urgenta Roman

Roman, Neamț County, 617385, Romania

Location

Spitalul Judetean de Urgenta Slatina, Sectie oncologie

Slatina, Olt, 230008, Romania

Location

Spitalul Municipal Campina Sectia oncologie

Câmpina, Prahova, 107425, Romania

Location

Spitalul Municipal Ploiesti Sectia oncologie

Ploieşti, Prahova, 100337, Romania

Location

Spitalul Municipal Medias Compartimentul Oncologie medicala

Mediaş, Sibiu County, 551026, Romania

Location

Spitalulul Clinic Judetean de Urgenta Sibiu- Sectia Oncologie medicala

Sibiu, Sibiu County, 550245, Romania

Location

Spitalulul Judetean de Urgenta, Sf. Ioan cel Nou

Suceava, Suceava, 720131, Romania

Location

Spitalul Clinic Municipal de Urgenta Timisoara Clinica Oncologie Medicala

Timișoara, Timiș County, 300223, Romania

Location

Spitalul Clinic Municipal Timisoara Sectia oncologie medicala

Timișoara, Timiș County, 300223, Romania

Location

Oncomed Srl

Timișoara, Timiș County, 300239, Romania

Location

Ambulator Spital Colentina, cabinet oncologie

Bucharest, 020142, Romania

Location

Cabinet Oncologie Medicala

Bucharest, 020947, Romania

Location

Ambulator Spital Sf. Pantelimon, cabinet oncolgie

Bucharest, 021659, Romania

Location

Institutul Oncologic "Prof. Dr. Al. Trestioreanu"

Bucharest, 022328, Romania

Location

Ambulator Spital Clinic Colţea, cabinet oncologie

Bucharest, 030171, Romania

Location

Policlinica Sf. Ioan Bucuresti, cabinet oncologie

Bucharest, 042121, Romania

Location

Policlinica Theodor Burghele, cabinet oncologie

Bucharest, 50659, Romania

Location

Ambulator Specialitate Cotroceni, cabinet oncolgie

Bucharest, 7000, Romania

Location

Str. Povernei 42, Sector 1

Bucharest, 7000, Romania

Location

Spitalul Clinic de Urgenta

Oradea, 410032, Romania

Location

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

Târgu Jiu, 210140, Romania

Location

Related Links

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

MeSH Terms

Interventions

exemestane

Limitations and Caveats

The study was prematurely terminated on 31 August 2012 due to unexpected high rate of participant withdrawal caused by Aromasin reimbursement policy change in Romania. There were no safety issues related to study termination.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: May 12, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 22, 2014
• Results First Posted: January 22, 2014

Record last verified: 2013-12

Locations

RO (40)