Aromasin® Non-Interventional Study Of Early Invasive Breast Cancer Patients In China
Aromasin® (Exemestane) was approved in China for adjuvant treatment of postmenopausal women with estrogen receptor (ER) positive early invasive breast cancer who have received 2-3 years of tamoxifen & are switched to Aromasin® for completion of a total of 5 consecutive years of adjuvant hormonal therapy by State Food and Drug Administration (SFDA) with clinical trial waive. While Aromasin® has been used in China for adjuvant therapy of breast cancer since then, there is currently lack of systematic collection and analysis for the efficacy and safety data of Aromasin® adjuvant setting in Chinese population. The Aromasin® Non-Interventional Study is being proposed to collect data systematically and to assess the efficacy and safety of Aromasin® adjuvant setting in Chinese population.
|Study Design:||Time Perspective: Prospective|
|Official Title:||A Prospective Non-interventional Study Of China Early Invasive Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin(Registered)|
- Time-to-event, where event is defined as the earliest occurrence any of the following: Locoregional/distant recurrence of the primary breast cancer; Appearance of 2nd primary or contralateral breast cancer; Death [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- The proportion of subjects experiencing the event [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- The incidence rate (per annum) defined as a ratio of the number of events and the total exposure times (in years) to Aromasin® therapy [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- The relationship between Her2 overexpression level and time-to-event [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- The incidence of adverse events and discontinuation of Aromasin® due to adverse event [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||March 2019|
|Estimated Primary Completion Date:||March 2019 (Final data collection date for primary outcome measure)|
This is a single arm NIS.
Drug: Aromasin (exemestane)
This is a NIS, the dosage, frequency and duration base on the LPD approved by SFDA.
Other Name: Aromasin (exemestane)
This is non-interventional study and single arm study. N/A
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176916
|Contact: Pfizer CT.gov Call Center||1-800-718-1021|
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|