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

Information source: Pfizer
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Neoplasms

Intervention: Aromasin (exemestane) (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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

Clinical Details

Official title: A Prospective Non-Interventional Study Of China Early Invasive Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin«

Study design: Time Perspective: Prospective

Primary outcome: 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

Secondary outcome:

The proportion of subjects experiencing the event

The incidence rate (per annum) defined as a ratio of the number of events and the total exposure times (in years) to Aromasin® therapy

The relationship between Her2 overexpression level and time-to-event

The incidence of adverse events and discontinuation of Aromasin® due to adverse event

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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®).

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Beijing 100191, China; Recruiting

Pfizer Investigational Site, Beijing 100071, China; Not yet recruiting

Pfizer Investigational Site, Beijing 100021, China; Recruiting

Pfizer Investigational Site, Chengdu 610041, China; Recruiting

Pfizer Investigational Site, Shanghai 200032, China; Not yet recruiting

Pfizer Investigational Site, Shanghai 200090, China; Recruiting

Pfizer Investigational Site, Tianjin 300060, China; Recruiting

Pfizer Investigational Site, Guangzhou, Guangdong 510260, China; Recruiting

Pfizer Investigational Site, Changsha, Hunan, China; Recruiting

Pfizer Investigational Site, Hangzhou, Zhejiang 310022, China; Recruiting

Additional Information

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

Starting date: February 2011
Last updated: February 4, 2013

Page last updated: February 07, 2013

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