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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01176916
First received: August 4, 2010
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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® Non-Interventional Study is being proposed to collect data systematically and to assess the efficacy and safety of Aromasin® adjuvant setting in Chinese population.


Condition Intervention
Breast Neoplasms
Drug: Aromasin (exemestane)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Prospective Non-Interventional Study Of China Early Invasive Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin®

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Time-to-event, where event is defined as the earliest occurrence any of the following: Locoregional/distant recurrence of the primary breast cancer; Appearance of 2nd primary or contralateral breast cancer; Death [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of subjects experiencing the event [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • The incidence rate (per annum) defined as a ratio of the number of events and the total exposure times (in years) to Aromasin® therapy [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • The relationship between Her2 overexpression level and time-to-event [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • The incidence of adverse events and discontinuation of Aromasin® due to adverse event [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 550
Study Start Date: February 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1.0
This is a single arm NIS.
Drug: Aromasin (exemestane)
This is a NIS, the dosage, frequency and duration base on the LPD approved by SFDA.
Other Name: Aromasin (exemestane)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Postmenopausal women with primary breast cancer with estrogen receptor positive switching to adjuvant Aromasin® endocrine therapy following adjuvant Tamoxifen therapy for 2-3 years

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®).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176916

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
China, Guangdong
The Second Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510260
ShenZhen Second Hospital/Department of Breast Surgery Recruiting
Shenzhen, Guangdong, China, 518035
China, Henan
Henan Cancer Hospital Recruiting
Zhenzhou, Henan, China
China, Hunan
Xiangya Hospital Centre-South University /Department of Breast Recruiting
Changsha, Hunan, China
China, Zhejiang
Zhejiang Cancer Hospital/Breast Oncology Recruiting
Hangzhou, Zhejiang, China, 310022
China
307 Hospital of PLA Not yet recruiting
Beijing, China, 100071
China-Japan Friendship Hospital Recruiting
Beijing, China
Peking University Third Hospital/Department of Oncology Recruiting
Beijing, China, 100191
Beijing Cancer Hospital Recruiting
Beijing, China
Cancer Institute and Hospital, Chinese Academy of Medical Science and Peking Union Medical College Recruiting
Beijing, China, 100021
Breast and thyroid surgery Department Recruiting
Changsha, China, 410005
Sichuan Provincial People's Hospital Recruiting
Chendu, China, 610072
West China Hospital, Sichuan University/ Thyroid & Breast Department Recruiting
Chengdu, China, 610041
The First Hospital Affiliated to Chongqing Medical University Not yet recruiting
Chongqing, China, 400016
The First Affiliated Hospital of Anhui Medical University Recruiting
Hefei, China
Jiangsu Province Hospital/ Surgery Department Recruiting
Nanjing, China, 210029
Fudan University Shanghai Cancer center/Department of Breast Surgery Recruiting
Shanghai, China, 200032
Yangpu District Central Hospital Recruiting
Shanghai, China, 200090
Suzhou Municipal Hospital Recruiting
Suzhou, China, 215002
Tianjin Oncology Hospital /Department of Breast Surgery Recruiting
Tianjin, China, 300060
Xinjiang Cancer Hospital Recruiting
Urumqi, China, 830000
The First Affiliated Hospital of Xi'an Jiaotong University/Oncology Surgery Recruiting
Xi'an, China, 710061
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01176916     History of Changes
Other Study ID Numbers: A5991093
Study First Received: August 4, 2010
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
breast cancer
Aromasin
adjuvant chemotherapy
endocrine therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Exemestane
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014