Aromasin® Interventional Study Of Early Invasive Breast Cancer Patients In China
A PROSPECTIVE PRAGMATIC CLINICAL TRIAL OF CHINA EARLY INVASIVE BREAST CANCER PATIENTS RECEIVING ADJUVANT THERAPY WITH AROMASIN
2 other identifiers
interventional
564
1 country
53
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2011
Longer than P75 for phase_4
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2010
CompletedFirst Posted
Study publicly available on registry
August 6, 2010
CompletedStudy Start
First participant enrolled
February 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2018
CompletedResults Posted
Study results publicly available
October 12, 2020
CompletedOctober 27, 2021
October 1, 2021
7.8 years
August 4, 2010
November 26, 2019
October 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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 (6)
Percentage of Participants Experiencing Each Event
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
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
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
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)
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)
- +1 more secondary outcomes
Study Arms (1)
A
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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®).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (53)
The First Affiliated Hospital of Bengbu Medical College/Medical Oncology Department
Bengbu, Anhui, 233004, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Second Affiliated hospital of Anhui Medical University
Hefei, Anhui, 230601, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
The First hospital of LanZhou university
Lanzhou, Gansu, 730000, China
Breast Surgery of The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260, China
SUN YAT-SEN Memorial Hospital , SUN YAT-SEN University
Guangzhou, Guangdong, 510260, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515041, China
Thyroid and breast surgery
Shenzhen, Guangdong, 518035, China
Affiliated hospital of Guangdong medical college
Zhanjiang, Guangdong, 524001, China
Hainan General Hospital
Haikou, Hainan, 570311, China
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
The First Affiliated Hospital of Xinxiang Medical University
Weihui, Henan, 453100, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Henan provincial people's hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Jingzhou Hospital Tongji Medical College Huazhong university of science and Technology
Jingzhou, Hubei, 434020, China
Breast and thyroid surgery of the Central Hospital of WuHan
Wuhan, Hubei, 430014, China
Hunan Provincial People's Hospital
Changsha, Hunan, 410005, China
Xiangya Hospital Central South University /Department of Breast
Changsha, Hunan, 410008, China
The Affiliated Hospital of inner Mongolia medical university
Hohhot, Inner Mongolia, 010021, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, 213004, China
Jiangsu Cancer Hospital/ Surgery Department
Nanjing, Jiangsu, 210000, China
Jinling Hospital
Nanjing, Jiangsu, 210002, China
Jiangsu Province Hospital/ Surgery Department
Nanjing, Jiangsu, 210029, China
Nanjing Maternity and Child Health Care Hospital/Department of Breast Surgery
Nanjing, Jiangsu, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215002, China
The first hospital of jilin university
Changchun, Jilin, 130021, China
The Fourth Affiliated Hospital Of China Medical University
Shenyang, Liaoning, 110032, China
The First Affiliated Hospital of The Fourth Military Medical University
Xi'an, Shaanxi, 710032, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Linyi People's Hospital
Linyi, Shandong, 276000, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266061, China
Qingdao municipal Hospital
Qingdao, Shandong, 266072, China
Breast Surgery of The Weifang People's Hospital
Weifang, Shandong, 261041, China
Breast Surgery of YanTai Yu Huang Ding Hospital
Yantai, Shandong, 264000, China
Breast and thyroid surgery of Central Hospital of Zibo
Zibo, Shandong, 255036, China
West China Hospital, Sichuan University/ Oncology Department
Chengdu, Sichuan, 610041, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000, China
Tianjin Cancer Hospital/Breast cancer department
Tianjin, Tianjin Municipality, 300060, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650118, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Cancer Hospital Chinese Academy of medical sciences
Beijing, 100021, China
Fifth Medical Center of the PLA General Hospital
Beijing, 100071, China
Beijing Cancer Hospital
Beijing, 100142, China
Peking University Third Hospital/Department of Oncology
Beijing, 100191, China
China-Japan Friendship Hospital
Beijing, China
Fudan University Shanghai Cancer center/Department of Breast Surgery
Shanghai, 200032, China
Yangpu District Central Hospital
Shanghai, 200090, China
Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, 200092, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Masking
- NONE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2010
First Posted
August 6, 2010
Study Start
February 9, 2011
Primary Completion
November 30, 2018
Study Completion
November 30, 2018
Last Updated
October 27, 2021
Results First Posted
October 12, 2020
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.