Aromasin® Interventional Study Of Early Invasive Breast Cancer Patients In China

An event was defined as the earliest occurrence of any of the following: 1) Loco-regional/distant recurrence of the primary breast cancer (BC) (Loco-regional recurrence was defined as any recurrence in the ipsilateral breast, chest wall or axillary lymph nodes.); 2) Appearance of a second primary or contralateral breast cancer; 3) Death due to any cause.

Time frame: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)

Population: The full analysis set (FAS) was defined as all participants who received at least 1 dose of Aromasin during the observation period. All efficacy analyses were performed using the FAS.

A Cox proportional hazards regression model with stepwise selection was used to evaluate the influence of multiple disease variables on the time-to-event. The disease variables in the initial model included Eastern Cooperative Oncology Group \[ECOG\] performance status at diagnosis; and Tumor, Lymph Node and Metastasis \[TNM\] stage at initial diagnosis. The ECOG Performance Status describes a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. ECOG performance status at diagnosis level included 0, 1, 2, 3 and 4, with Level 0 as the best status and Level 4 as the worst. The TNM system helps describe the size of cancer tumor and the extent to which it spreads to nearby tissues/distant parts of the body. TNM stage at initial diagnosis level included 1 (Stage I), 2 (Stage IIA), 3 (Stage IIB), 4 (Stage IIIA), 5 (Stage IIIB) and 6 (Stage IIIC), with Level 1 as the best status and Level 6 as the worst.

Time frame: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)

Population: The FAS was defined as all participants who received at least 1 dose of Aromasin during the observation period. All efficacy analyses were performed using the FAS.

A Cox proportional hazards regression model was used to evaluate the relationship between HER2 status level (binary) and time-to-event (Positive vs Negative). The method for selecting factors for the Cox regression model was based on significant results at univariate analysis and the clinical judgement for the multivariate model. Stepwise method was used for the selection of final independent variables. The criteria for stepwise selection were pentry = 0.25 and pstay = 0.15.

Time frame: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)

Population: The FAS was defined as all participants who received at least 1 dose of Aromasin during the observation period. All efficacy analyses were performed using the FAS.

Incidence rate (per annum) of the event was defined as a ratio of the number of events and the total exposure time (in years) to Aromasin therapy.

Time frame: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)

Population: The FAS was defined as all participants who received at least 1 dose of Aromasin during the observation period. All efficacy analyses were performed using the FAS.

Participants permanently discontinued from the study due to AEs were counted for this outcome measure. An AE is any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. The number of participants with discontinuation due to all-causality and treatment-related AEs are reported below. Treatment-related AEs were determined by the investigator.

Time frame: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)

Population: The safety analysis set (SAS) was defined as all enrolled participants who took at least 1 dose of the study drug. All safety analyses were reported within the SAS.

All-causality TEAEs were counted for this outcome measure. TEAE is defined as an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state. The number of participants with all-causality and treatment-related TEAEs are reported below. Treatment-related TEAEs were determined by the investigator.

Time frame: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)

Population: The SAS was defined as all enrolled participants who took at least 1 dose of the study drug. All safety analyses were reported within the SAS.

An event was defined as the following: 1) Loco-regional/distant recurrence of the primary breast cancer (Loco-regional recurrence was defined as any recurrence in the ipsilateral breast, chest wall or axillary lymph nodes.); 2) Appearance of a second primary or contralateral breast cancer; 3) Death due to any cause.

Time frame: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)

Population: The FAS was defined as all participants who received at least 1 dose of Aromasin during the observation period. All efficacy analyses were performed using the FAS.