A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer In Postmenopausal Hormone Receptors Positive Patients Following Of 2-3 Years of Initial Adjuvant Tamoxifen Therapy
This is a prospective, non-comparative, non interventional study (NIS) in four hundred (400)
postmenopausal women hormone-receptor positive invasive with early breast cancer, following
2-3 years of initial adjuvant tamoxifen therapy conducted in 60 sites from Romania according
to protocol A5991091.The selection of patients based on diagnosis, the attribution of
medicinal products and the follow-up of the subjects fall within the current medical
practice. A Non-Interventional study is primarily observational in nature. The present
Non-interventional Study is performed by medical oncologist and medical oncologist
/radiation oncologist who agree to take part in this project. n/a The study was prematurely
terminated on August 31th 2012 due to unexpected high rate of patient withdrawal caused by
Aromasin reimbursement policy change in Romania; There were no safety issues related to
study termination.
Observational
Time Perspective: Prospective
Overall Safety profile characterized by type, frequency and severity, as graded is using the NCI/CTEP Common Technology Criteria for Adverse Events version 4.0 (CTCAE, v4.0) and its relationship with study therapy
6 months
Yes
Pfizer CT.gov Call Center
Study Director
Pfizer
Romania: Romanian National Medicine Agency
A5991091
NCT01121549
February 2010
December 2012
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