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

Breast Neoplasms Clinical Trial

Official title:

A PROSPECTIVE PRAGMATIC CLINICAL TRIAL OF CHINA EARLY INVASIVE BREAST CANCER PATIENTS RECEIVING ADJUVANT THERAPY WITH AROMASIN

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176916
• Other study ID #: A5991093
• Secondary ID: NRA5990043
• Status: Completed
• Phase: Phase 4
• Start date: February 9, 2011
• Est. completion date: November 30, 2018

Study information

• Verified date: October 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 564
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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®).

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Aromasin (exemestane)
the dosage, frequency and duration base on the LPD approved by SFDA.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing
China	Cancer Hospital Chinese Academy of medical sciences	Beijing
China	China-Japan Friendship Hospital	Beijing
China	Fifth Medical Center of the PLA General Hospital	Beijing
China	Peking University Third Hospital/Department of Oncology	Beijing
China	The First Affiliated Hospital of Bengbu Medical College/Medical Oncology Department	Bengbu	Anhui
China	The first hospital of jilin university	Changchun	Jilin
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	Xiangya Hospital Central South University /Department of Breast	Changsha	Hunan
China	Changzhou No.2 People's Hospital	Changzhou	Jiangsu
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	West China Hospital, Sichuan University/ Oncology Department	Chengdu	Sichuan
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	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	Hainan General Hospital	Haikou	Hainan
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Second Affiliated hospital of Anhui Medical University	Hefei	Anhui
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The Affiliated Hospital of inner Mongolia medical university	Hu He Hao Te	Inner Mongolia
China	Jingzhou Hospital Tongji Medical College Huazhong university of science and Technology	Jingzhou	Hubei
China	Yunnan Cancer Hospital	Kunming	Yunnan
China	The First hospital of LanZhou university	Lanzhou	Gansu
China	Linyi People's Hospital	Linyi	Shandong
China	Affiliated Hospital of North Sichuan Medical College	Nanchong	Sichuan
China	Jiangsu Cancer Hospital/ Surgery Department	Nanjing	Jiangsu
China	Jiangsu Province Hospital/ Surgery Department	Nanjing	Jiangsu
China	Jinling Hospital	Nanjing	Jiangsu
China	Nanjing Maternity and Child Health Care Hospital/Department of Breast Surgery	Nanjing	Jiangsu
China	Qingdao municipal Hospital	Qingdao	Shandong
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Fudan University Shanghai Cancer center/Department of Breast Surgery	Shanghai
China	Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine	Shanghai
China	Yangpu District Central Hospital	Shanghai
China	Cancer Hospital of Shantou University Medical College	Shantou	Guangdong
China	The Fourth Affiliated Hospital Of China Medical University	ShenYang	Liaoning
China	Thyroid and breast surgery	Shenzhen City	Guangdong
China	Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Suzhou Municipal Hospital	Suzhou	Jiangsu
China	Tianjin Cancer Hospital/Breast cancer department	Tianjin	Tianjin
China	Affiliated Cancer Hospital of Xinjiang Medical University	Urumchi	Xinjiang
China	Breast Surgery of The Weifang People's Hospital	Weifang	Shandong
China	The First Affiliated Hospital of Xinxiang Medical University	Weihui	Henan
China	Breast and thyroid surgery of the Central Hospital of WuHan	WuHan	Hubei
China	The First Affiliated Hospital of The Fourth Military Medical University	Xi'an	Shaanxi
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Breast Surgery of YanTai Yu Huang Ding Hospital	Yan Tai	Shandong
China	Affiliated hospital of Guangdong medical college	ZhanJiang	Guangdong
China	Henan Cancer Hospital	Zhengzhou	Henan
China	Henan provincial people's hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Breast and thyroid surgery of Central Hospital of Zibo	Zibo	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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	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.	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	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.	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	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.	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	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.	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	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.	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)

External Links

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