A Survey Of Clinical Practice Of Adjuvant Treatment Of Breast Cancer Using Exemestane (Aromasin®) In Postmenopausal Hr+ Patients (ETAPE)
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|ClinicalTrials.gov Identifier: NCT01305239|
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : February 28, 2011
Results First Posted : April 10, 2012
Last Update Posted : April 10, 2012
|Condition or disease||Intervention/treatment|
|Breast Cancer||Drug: Aromasin|
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|
|Actual Enrollment :||398 participants|
|Official Title:||A Survey Of Clinical Practice Of Adjuvant Treatment Of Breast Cancer Using Exemestane (Aromasin®) In Postmenopausal Hr+ Patients|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
|Postmenopausal ER+ patients treated by Aromasin.||
Aromasin 25 mg daily.
Other Name: Exemestane
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed ]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.
- 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 [ Time Frame: Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed ]Compliant with treatment = followed treatment regimen with exemestane according to initial prescription.
- Duration of Treatment [ Time Frame: Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed ]Total duration of adjuvant hormonal therapy with exemestane.
- Event-free Survival [ Time Frame: Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305239
|Study Director:||Pfizer CT.gov Call Center||Pfizer|