Trial Information
A Prospective Non-Interventional Study Of China Early Invasive Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin®
This is non-interventional study and single arm study. N/A
Inclusion Criteria:
- Early invasive breast cancer (T1-4N1-3M0) confirmed by histology or cytology.
- ER positive.
- The patient must be postmenopausal woman.
- The patient has received adjuvant Tamoxifen therapy for up to 2-3 years and will
switch to receive Aromasin® treatment (The decision to prescribe Aromasin® will
necessarily precede and will be independent of the decision to enroll patients in the
study).
Exclusion Criteria:
- Following the adjuvant Tamoxifen therapy for 2-3 years and prior to receiving
Aromasin® treatment, there is evidence of a local relapse or distant metastasis of
breast cancer, or a second primary cancer.
- Following the adjuvant Tamoxifen therapy for 2-3 years and received other aromatase
inhibitors (not Aromasin®).
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Outcome Measure:
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
Outcome Time Frame:
7 years
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A5991093
NCT ID:
NCT01176916
Start Date:
February 2011
Completion Date:
December 2017
Related Keywords:
- Breast Neoplasms
- breast cancer
- Aromasin
- adjuvant chemotherapy
- endocrine therapy
- Breast Neoplasms
- Neoplasms