Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer

Pfizer46 enrolled

Overview

This non-interventional study will be conducted in several Eastern European countries to assess the safety, tolerability and efficacy of Aromasin® when it is administered in real-word setting in postmenopausal women with invasive estrogen receptor positive early breast cancer , who are disease-free after completion of 2 to 3 years of tamoxifen and continue the treatment with Aromasin® until completion of 5 years of adjuvant hormonal therapy, to understand how Aromasin® is used in routine clinical practice, to assess adherence to prescribed Aromasin® treatment and to understand reasons for its early discontinuation.

The study prematurely discontinued on October 11, 2011 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Neoplasms

Interventions

AromasinDRUG

Aromasin® one 25 mg tablet to be taken once daily

Medical Language ↔ Plain English

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 histologically confirmed breast cancer that was non-metastatic at the time of the initial diagnosis. * Patients who are disease-free after 2 to 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). * Metastatic breast cancer or a contra lateral tumour. * Other concomitant adjuvant endocrine therapy. * Other concomitant antineoplastic treatment. * Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.

Locations (11)

General Hospital Karlovac

Karlovac, Croatia

University Hospital Center Osijek

Osijek, Croatia

General Hospital Pula

Pula, Croatia

University Hospital Center Rijeka

Rijeka, Croatia

University Hospital Center Split

Split, Croatia

General Hospital Varazdin

Varaždin, Croatia

Clinic for Tumors

Zagreb, Croatia

University Hospital Center "Sestre milosrdnice"

Zagreb, Croatia

North Estonia Medical Centre Foundation

Tallinn, Estonia

Institute for Oncology and Radiology of Serbia

Belgrade, Serbia

...and 1 more locations

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs)

Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness (to study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.