Observational survey aiming to evaluate the tolerability of Aromasin and the ways in which it is used in clinical practice in France (as adjuvant endocrine therapy).
It was hypothesized that 200 participating doctors would provide the survey with sufficient statistical precision to meet the objectives, with each participating doctor recruiting up to 6 patients. An initial sample of 1000 doctors should be contacted (letter, phone). These 1000 doctors will initially be chosen at random from a file held by Pfizer of doctors who have agreed to take part in a Pfizer survey. These doctors will be experienced and qualified in the treatment and management of patients with non-metastatic, surgically-treated breast cancer (medical oncologists, gynaecologists, and medical oncologists/ radiation oncologists). They are practicing in general hospitals, teaching hospitals, CRLCC cancer centres and private clinics treating patients with breast cancer. Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on December 3, 2010. There were no safety concerns involved in the decision to stop enrollment.
Study Type
OBSERVATIONAL
Enrollment
398
Aromasin 25 mg daily.
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any untoward medical occurrence in a patient who received study drug was considered an adverse event without regard to possibility of causal relationship. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed
Reasons for Discontinuation of Aromasin Therapy
Time frame: Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed
Percentage of Participants Who Were Compliant With Treatment
Compliant with treatment = followed treatment regimen with exemestane according to initial prescription.
Time frame: Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed
Duration of Treatment
Total duration of adjuvant hormonal therapy with exemestane.
Time frame: Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed
Event-free Survival
Event-free survival: time between first intake of exemestane and date of last follow-up or date of death for deceased participants (date of relapse or death or last follow-up minus first intake date) + 1 / 365.25 \* 12.
Time frame: Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed
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