An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin

• Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer [ Time Frame: Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5) ] [ Designated as safety issue: Yes ]
  Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.
  
  
• Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer [ Time Frame: Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5) ] [ Designated as safety issue: Yes ]
  
• Number of Participants Who Died [ Time Frame: Baseline until death (up to Year 3.5) ] [ Designated as safety issue: Yes ]
  
• Number of Participants Who Discontinued Aromasin Therapy [ Time Frame: Baseline until discontinuation (up to Year 3.5) ] [ Designated as safety issue: No ]
  
• Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs) [ Time Frame: Baseline up to 28 days after last dose of study treatment ] [ Designated as safety issue: Yes ]
  An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs related to gynecological, cardiac, venous thromboembolic, musculoskeletal and menopausal symptoms were reported. Gynecological AEs: bleeding, discharge, uterine dilatation and curettage; cardiac AEs: myocardial infarction, hypertension; musculoskeletal: joint stiffness, arthralgia, muscle cramps, fractures; menopausal symptoms: hot flushes, anxiety, depression, headache.
  
  
• Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Total Cholesterol and Triglycerides at Month 6, 12, 18, 24, 30, 36 and 42 [ Time Frame: Baseline, Month 6, 12, 18, 24, 30, 36, 42 ] [ Designated as safety issue: Yes ]
  
• Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42 [ Time Frame: Baseline, Month 6, 12, 18, 24, 30, 36, 42 ] [ Designated as safety issue: Yes ]
  

NA The study was prematurely discontinued due to slow enrollment and keeping in mind the observational nature of the study. The decision to terminate had been taken on 16th June 2012 and the LSLV occured on 14th September, 2012. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.