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

Early Breast Cancer Clinical Trial

Official title:

A Non-Interventional Observational Study Evaluating The Effects Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy On Safety In Postmenopausal And Hormone Receptors Positive Early Breast Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01155063
• Other study ID #: A5991092
• Status: Terminated
• Phase: N/A
• First received: June 28, 2010
• Last updated: September 25, 2012
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: September 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Central Ethic Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 89
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Early Breast Cancer

Intervention

Other:
• Aromasin (exemestane)
Aromasin (exemestane), tablets 25 mg, once a day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs)	An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication.	Month 0 up to Month 36 or early withdrawal	Yes
Secondary	Number of Participants With Concomitant Morbidities	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.	Month 0 up to Month 36 or early withdrawal	No
Secondary	Number of Participants With Concomitant Medications	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.	Month 0 up to Month 36 or early withdrawal	No
Secondary	Percentage of Participants Who Discontinued the Study Medication		Month 0 up to Month 36 or early withdrawal	No
Secondary	Number of Participants With Reasons for Discontinuation From Study Treatment		Month 0 up to Month 36 or early withdrawal	No
Secondary	Time to Discontinuation of Study Medication		Month 0 up to Month 36 or early withdrawal	No
Secondary	Percentage of Participants With Recurrent Disease	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).	Month 36 or early withdrawal	No

External Links

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