A Survey Of Clinical Practice Of Adjuvant Treatment Of Breast Cancer Using Exemestane (Aromasin®) In Postmenopausal Hr+ Patients
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
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
Observational Model: Cohort, Time Perspective: Prospective
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.
Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed
Pfizer CT.gov Call Center
United States: Food and Drug Administration