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

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms
• Intervention / Treatment: Drug: Aromasin (exemestane)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 564
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Beijing, China
    • China-Japan Friendship Hospital
  • Beijing, China, 100021
    • Cancer Hospital Chinese Academy of Medical Sciences
  • Beijing, China, 100071
    • Fifth Medical Center of the PLA General Hospital
  • Beijing, China, 100191
    • Peking University Third Hospital/Department of Oncology
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer center/Department of Breast Surgery
  • Shanghai, China, 200090
    • Yangpu District Central Hospital
  • Shanghai, China, 200092
    • Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
  • Anhui
    • Bengbu, Anhui, China, 233004
      • The First Affiliated Hospital of Bengbu Medical College/Medical Oncology Department
    • Hefei, Anhui, China, 230022
      • The First Affiliated Hospital of Anhui Medical University
    • Hefei, Anhui, China, 230601
      • Second Affiliated hospital of Anhui Medical University
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • The First Affiliated Hospital of Chongqing Medical University
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • The First Hospital of Lanzhou University
  • Guangdong
    • Guangzhou, Guangdong, China, 510260
      • Breast Surgery of The Second Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China, 510260
      • Sun Yat-sen Memorial Hospital , Sun Yat-sen University
    • Shantou, Guangdong, China, 515041
      • Cancer Hospital of Shantou University Medical College
    • Shenzhen City, Guangdong, China, 518035
      • Thyroid and breast surgery
    • ZhanJiang, Guangdong, China, 524001
      • Affiliated Hospital of Guangdong Medical College
  • Hainan
    • Haikou, Hainan, China, 570311
      • Hainan General Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • Fourth Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital
  • Henan
    • Weihui, Henan, China, 453100
      • The First Affiliated Hospital of Xinxiang Medical University
    • Zhengzhou, Henan, China, 450000
      • The First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China, 450000
      • Henan Cancer Hospital
    • Zhengzhou, Henan, China, 450000
      • Henan Provincial People's Hospital
  • Hubei
    • Jingzhou, Hubei, China, 434020
      • Jingzhou Hospital Tongji Medical College Huazhong university of science and Technology
    • WuHan, Hubei, China, 430014
      • Breast and thyroid surgery of the Central Hospital of WuHan
  • Hunan
    • Changsha, Hunan, China, 410005
      • Hunan Provincial People's Hospital
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University /Department of Breast
  • Inner Mongolia
    • Hu He Hao Te, Inner Mongolia, China, 010021
      • The Affiliated Hospital of Inner Mongolia Medical University
  • Jiangsu
    • Changzhou, Jiangsu, China, 213004
      • Changzhou No.2 People's Hospital
    • Nanjing, Jiangsu, China, 210002
      • Jinling Hospital
    • Nanjing, Jiangsu, China, 210000
      • Jiangsu Cancer Hospital/ Surgery Department
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital/ Surgery Department
    • Nanjing, Jiangsu, China
      • Nanjing Maternity and Child Health Care Hospital/Department of Breast Surgery
    • Suzhou, Jiangsu, China, 215002
      • Suzhou Municipal Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Liaoning
    • ShenYang, Liaoning, China, 110032
      • the Fourth Affiliated Hospital of China Medical University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xi'An JiaoTong University
    • Xi'an, Shaanxi, China, 710032
      • The First Affiliated Hospital of the Fourth Military Medical University
  • Shandong
    • Linyi, Shandong, China, 276000
      • Linyi People's Hospital
    • Qingdao, Shandong, China, 266061
      • The Affiliated Hospital of Qingdao University
    • Qingdao, Shandong, China, 266072
      • Qingdao Municipal Hospital
    • Weifang, Shandong, China, 261041
      • Breast Surgery of The Weifang People's Hospital
    • Yan Tai, Shandong, China, 264000
      • Breast Surgery of YanTai Yu Huang Ding Hospital
    • Zibo, Shandong, China, 255036
      • Breast and thyroid surgery of Central Hospital of Zibo
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Sichuan Provincial People's Hospital
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University/ Oncology Department
    • Nanchong, Sichuan, China, 637000
      • Affiliated Hospital of North Sichuan Medical College
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Cancer Hospital/Breast cancer department
  • Xinjiang
    • Urumchi, Xinjiang, China, 830000
      • Affiliated Cancer Hospital of Xinjiang Medical University
  • Yunnan
    • Kunming, Yunnan, China, 650118
      • Yunnan Cancer Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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®).

Study Plan

How is the study designed?

Design Details

• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A	Drug: Aromasin (exemestane); the dosage, frequency and duration base on the LPD approved by SFDA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 9, 2011
• Primary Completion (ACTUAL): November 30, 2018
• Study Completion (ACTUAL): November 30, 2018

Study Registration Dates

• First Submitted: August 4, 2010
• First Submitted That Met QC Criteria: August 4, 2010
• First Posted (ESTIMATE): August 6, 2010

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: breast cancer; adjuvant chemotherapy; Aromasin; endocrine therapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Exemestane
• Other Study ID Numbers: A5991093; NRA5990043 (OTHER: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.