Clinical trial NCT01176916: Aromasin® Interventional Study Of Early Invasive Breast Cancer Patients In China
Official title: A PROSPECTIVE PRAGMATIC CLINICAL TRIAL OF CHINA EARLY INVASIVE BREAST CANCER PATIENTS RECEIVING ADJUVANT THERAPY WITH AROMASIN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Neoplasms
Keywords: breast cancer
Aromasin
adjuvant chemotherapy
endocrine therapy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-08-06
Enrollment: 564
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: 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.

Detailed description: This is interventional study and single arm study. N/A

Eligibility criteria: 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®).

Primary outcomes:
measure: Time-to-Event
timeFrame: 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)
Secondary outcomes:
measure: Percentage of Participants Experiencing Each Event
timeFrame: 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)
measure: Incidence Rate of Each Event
timeFrame: 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)
measure: Hazard Ratio: the Relationship Between (Human Epidermal Growth Factor Receptor 2) HER2 Status and Time-to-Event
timeFrame: 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)
measure: Harzard Ratio: the Relationship Between Multiple Disease Variables and Time-to-Event
timeFrame: 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)
measure: Number of Participants With Discontinuation Due to Adverse Events (AEs)
timeFrame: 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)
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: 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)
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College/Medical Oncology Department
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: Second Affiliated hospital of Anhui Medical University
state: Anhui
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Lanzhou
country: China
facility: The First hospital of LanZhou university
state: Gansu
city: Guangzhou
country: China
facility: Breast Surgery of The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: SUN YAT-SEN Memorial Hospital , SUN YAT-SEN University
state: Guangdong
city: Shantou
country: China
facility: Cancer Hospital of Shantou University Medical College
state: Guangdong
city: Shenzhen City
country: China
facility: Thyroid and breast surgery
state: Guangdong
city: ZhanJiang
country: China
facility: Affiliated hospital of Guangdong medical college
state: Guangdong
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Weihui
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan provincial people's hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Jingzhou
country: China
facility: Jingzhou Hospital Tongji Medical College Huazhong university of science and Technology
state: Hubei
city: WuHan
country: China
facility: Breast and thyroid surgery of the Central Hospital of WuHan
state: Hubei
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University /Department of Breast
state: Hunan
city: Hu He Hao Te
country: China
facility: The Affiliated Hospital of inner Mongolia medical university
state: Inner Mongolia
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital/ Surgery Department
state: Jiangsu
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital/ Surgery Department
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital/Department of Breast Surgery
state: Jiangsu
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Jiangsu
city: Changchun
country: China
facility: The first hospital of jilin university
state: Jilin
city: ShenYang
country: China
facility: The Fourth Affiliated Hospital Of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of The Fourth Military Medical University
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Linyi
country: China
facility: Linyi People's Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Qingdao
country: China
facility: Qingdao municipal Hospital
state: Shandong
city: Weifang
country: China
facility: Breast Surgery of The Weifang People's Hospital
state: Shandong
city: Yan Tai
country: China
facility: Breast Surgery of YanTai Yu Huang Ding Hospital
state: Shandong
city: Zibo
country: China
facility: Breast and thyroid surgery of Central Hospital of Zibo
state: Shandong
city: Chengdu
country: China
facility: West China Hospital, Sichuan University/ Oncology Department
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Nanchong
country: China
facility: Affiliated Hospital of North Sichuan Medical College
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Cancer Hospital/Breast cancer department
state: Tianjin
city: Urumchi
country: China
facility: Affiliated Cancer Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of medical sciences
city: Beijing
country: China
facility: Fifth Medical Center of the PLA General Hospital
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Peking University Third Hospital/Department of Oncology
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer center/Department of Breast Surgery
city: Shanghai
country: China
facility: Yangpu District Central Hospital
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: