Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||A Non-Interventional Study With Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy|
- Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Month 36 ] [ Designated as safety issue: Yes ]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.
- Number of Participants With Concomitant Morbidities [ Time Frame: Baseline up to Month 36 ] [ Designated as safety issue: No ]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.
- Number of Participants With Concomitant Medications [ Time Frame: Baseline up to Month 36 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline up to Month 36 ] [ Designated as safety issue: No ]
- Number of Participants With Reasons for Discontinuation From Study Medication [ Time Frame: Baseline up to Month 36 ] [ Designated as safety issue: No ]
- Time to Discontinuation [ Time Frame: Baseline up to Month 36 ] [ Designated as safety issue: No ]
- Recurrence-free Survival [ Time Frame: Baseline up to Month 36 ] [ Designated as safety issue: No ]Recurrence-free survival defined as the time from the initiation of study medication to the date of confirmation of any recurrence - as local or distant breast cancer recurrence; new primary breast cancer (ipsilateral or contralateral), death due to any cause.
- Overall Survival [ Time Frame: Baseline until death (up to Month 36) ] [ Designated as safety issue: No ]Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
|Study Start Date:||April 2011|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Aromasin® one 25 mg tablet to be taken once daily
Other Name: Exemestane
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239745
|General Hospital Karlovac|
|Karlovac, Croatia, 47000|
|University Hospital Center Osijek|
|Osijek, Croatia, 31000|
|General Hospital Pula|
|Pula, Croatia, 52000|
|University Hospital Center Rijeka|
|Rijeka, Croatia, 51000|
|University Hospital Center Split|
|Split, Croatia, 21000|
|General Hospital Varazdin|
|Varazdin, Croatia, 42000|
|Clinic for Tumors|
|Zagreb, Croatia, 10000|
|University Hospital Center "Sestre milosrdnice"|
|Zagreb, Croatia, 10000|
|North Estonia Medical Centre Foundation|
|Tallinn, Estonia, 13419|
|Institute for Oncology and Radiology of Serbia|
|Belgrade, Serbia, 11000|
|Oncology Clinic, Medical center, Bezanijska Kosa|
|Beograd, Serbia, 11080|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|