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

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Exemestane

U.S. FDA Resources

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

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
Pfizer Investigational Site	Recruiting
Guangzhou, Guangdong, China, 510260
China, Hunan
Pfizer Investigational Site	Recruiting
Changsha, Hunan, China
China, Zhejiang
Pfizer Investigational Site	Recruiting
Hangzhou, Zhejiang, China, 310022
China
Pfizer Investigational Site	Not yet recruiting
Beijing, China, 100071
Pfizer Investigational Site	Recruiting
Beijing, China, 100191
Pfizer Investigational Site	Recruiting
Beijing, China, 100021
Pfizer Investigational Site	Recruiting
Chengdu, China, 610041
Pfizer Investigational Site	Not yet recruiting
Shanghai, China, 200032
Pfizer Investigational Site	Recruiting
Shanghai, China, 200090
Pfizer Investigational Site	Recruiting
Tianjin, China, 300060

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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:	May 6, 2013
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 May 19, 2013