Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients

Terminated

• Conditions: Early Breast Cancer
• Interventions: Other: Aromasin (exemestane)

• Registration Number: NCT01155063
• Lead Sponsor: Pfizer

Brief Summary

Evaluating the safety, tolerability and efficacy of Aromasin® when used in routine clinical practice, evaluating adherence to prescribed Aromasin® treatment and to understand reasons for early discontinuation.

Detailed Description

This study was terminated on 01-Aug-2011 due to very low potential to enroll planned number of patients or any sufficient number of patients for complete statistical analyses. This study is not being terminated because of safety or efficacy concerns.

Study Timeline

• Study First Submitted: 2010-06-28
• Study First Submitted QC: 2010-06-29
• Study First Posted: 2010-07-01
• Study Start: 2010-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Results First Submitted: 2012-08-17
• Results First Submitted QC: 2012-08-17
• Status Verified: 2012-09
• Results First Posted: 2012-09-20
• Last Update Submitted: 2012-09-25
• Last Update Posted: 2012-10-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 89

Inclusion Criteria

• Postmenopausal females.
• 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 SPC).
• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Main Group	Aromasin (exemestane)	Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	Month 0 up to Month 36 or early withdrawal	An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Reasons for Discontinuation From Study Treatment	Month 0 up to Month 36 or early withdrawal
Time to Discontinuation of Study Medication	Month 0 up to Month 36 or early withdrawal
Number of Participants With Concomitant Medications	Month 0 up to Month 36 or early withdrawal	Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary.
Percentage of Participants Who Discontinued the Study Medication	Month 0 up to Month 36 or early withdrawal
Number of Participants With Concomitant Morbidities	Month 0 up to Month 36 or early withdrawal	Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.
Percentage of Participants With Recurrent Disease	Month 36 or early withdrawal	Percentage of participants with confirmed recurrent disease at the end of the study (recurrence was defined as loco-regional and/or contralateral and/or distance metastases).