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® Interventional Study is being proposed to collect data systematically and to assess the efficacy and safety of Aromasin® adjuvant setting in Chinese population.
This is interventional study and single arm study. N/A
Study Type
INTERVENTIONAL
Masking
NONE
Enrollment
564
the dosage, frequency and duration base on the LPD approved by SFDA.
The First Affiliated Hospital of Bengbu Medical College/Medical Oncology Department
Bengbu, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Second Affiliated hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First hospital of LanZhou university
Lanzhou, Gansu, China
Time-to-Event
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)
Percentage of Participants Experiencing Each Event
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)
Incidence Rate of Each Event
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)
Hazard Ratio: the Relationship Between (Human Epidermal Growth Factor Receptor 2) HER2 Status and Time-to-Event
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)
Harzard Ratio: the Relationship Between Multiple Disease Variables and Time-to-Event
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)
Number of Participants With Discontinuation Due to Adverse Events (AEs)
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)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Breast Surgery of The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
SUN YAT-SEN Memorial Hospital , SUN YAT-SEN University
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
Thyroid and breast surgery
Shenzhen, Guangdong, China
Affiliated hospital of Guangdong medical college
Zhanjiang, Guangdong, China
...and 43 more locations