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

NCT ID: NCT01176916

Last Updated: 2021-10-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

564 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-09

Study Completion Date

2018-11-30

Brief Summary

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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

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This is interventional study and single arm study. N/A

Conditions

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Breast Neoplasms

Keywords

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breast cancer Aromasin adjuvant chemotherapy endocrine therapy

Study Design

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Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Aromasin (exemestane)

Intervention Type DRUG

the dosage, frequency and duration base on the LPD approved by SFDA.

Interventions

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Aromasin (exemestane)

the dosage, frequency and duration base on the LPD approved by SFDA.

Intervention Type DRUG

Eligibility Criteria

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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®).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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The First Affiliated Hospital of Bengbu Medical College/Medical Oncology Department

Bengbu, Anhui, China

Site Status

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status

Second Affiliated hospital of Anhui Medical University

Hefei, Anhui, China

Site Status

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

The First hospital of LanZhou university

Lanzhou, Gansu, China

Site Status

Breast Surgery of The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

SUN YAT-SEN Memorial Hospital , SUN YAT-SEN University

Guangzhou, Guangdong, China

Site Status

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

Site Status

Thyroid and breast surgery

Shenzhen, Guangdong, China

Site Status

Affiliated hospital of Guangdong medical college

Zhanjiang, Guangdong, China

Site Status

Hainan General Hospital

Haikou, Hainan, China

Site Status

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Site Status

The First Affiliated Hospital of Xinxiang Medical University

Weihui, Henan, China

Site Status

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status

Henan provincial people's hospital

Zhengzhou, Henan, China

Site Status

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Jingzhou Hospital Tongji Medical College Huazhong university of science and Technology

Jingzhou, Hubei, China

Site Status

Breast and thyroid surgery of the Central Hospital of WuHan

Wuhan, Hubei, China

Site Status

Hunan Provincial People's Hospital

Changsha, Hunan, China

Site Status

Xiangya Hospital Central South University /Department of Breast

Changsha, Hunan, China

Site Status

The Affiliated Hospital of inner Mongolia medical university

Hohhot, Inner Mongolia, China

Site Status

Changzhou No.2 People's Hospital

Changzhou, Jiangsu, China

Site Status

Jiangsu Cancer Hospital/ Surgery Department

Nanjing, Jiangsu, China

Site Status

Jinling Hospital

Nanjing, Jiangsu, China

Site Status

Jiangsu Province Hospital/ Surgery Department

Nanjing, Jiangsu, China

Site Status

Nanjing Maternity and Child Health Care Hospital/Department of Breast Surgery

Nanjing, Jiangsu, China

Site Status

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

Site Status

The first hospital of jilin university

Changchun, Jilin, China

Site Status

The Fourth Affiliated Hospital Of China Medical University

Shenyang, Liaoning, China

Site Status

The First Affiliated Hospital of The Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status

Linyi People's Hospital

Linyi, Shandong, China

Site Status

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status

Qingdao municipal Hospital

Qingdao, Shandong, China

Site Status

Breast Surgery of The Weifang People's Hospital

Weifang, Shandong, China

Site Status

Breast Surgery of YanTai Yu Huang Ding Hospital

Yantai, Shandong, China

Site Status

Breast and thyroid surgery of Central Hospital of Zibo

Zibo, Shandong, China

Site Status

West China Hospital, Sichuan University/ Oncology Department

Chengdu, Sichuan, China

Site Status

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Site Status

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, China

Site Status

Tianjin Cancer Hospital/Breast cancer department

Tianjin, Tianjin Municipality, China

Site Status

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status

Yunnan Cancer Hospital

Kunming, Yunnan, China

Site Status

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status

Cancer Hospital Chinese Academy of medical sciences

Beijing, , China

Site Status

Fifth Medical Center of the PLA General Hospital

Beijing, , China

Site Status

Beijing Cancer Hospital

Beijing, , China

Site Status

Peking University Third Hospital/Department of Oncology

Beijing, , China

Site Status

China-Japan Friendship Hospital

Beijing, , China

Site Status

Fudan University Shanghai Cancer center/Department of Breast Surgery

Shanghai, , China

Site Status

Yangpu District Central Hospital

Shanghai, , China

Site Status

Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine

Shanghai, , China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://trialinfoemail.pfizer.com

To obtain contact information for a study center near you, click here.

Other Identifiers

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NRA5990043

Identifier Type: OTHER

Identifier Source: secondary_id

A5991093

Identifier Type: -

Identifier Source: org_study_id