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

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Exemestane; Tamoxifen

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.