Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01176916
First received: August 4, 2010
Last updated: August 12, 2016
Last verified: August 2016

August 4, 2010
August 12, 2016
February 2011
December 2018   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01176916 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Aromasin® Non-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® Non-Interventional Study is being proposed to collect data systematically and to assess the efficacy and safety of Aromasin® adjuvant setting in Chinese population.
This is non-interventional study and single arm study. N/A
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Postmenopausal women with primary breast cancer with estrogen receptor positive switching to adjuvant Aromasin® endocrine therapy following adjuvant Tamoxifen therapy for 2-3 years
Breast Neoplasms
Drug: Aromasin (exemestane)
This is a NIS, the dosage, frequency and duration base on the LPD approved by SFDA.
1.0
This is a single arm NIS.
Intervention: Drug: Aromasin (exemestane)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
550
December 2018
December 2018   (final data collection date for primary outcome measure)

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®).
Female
Child, Adult, Senior
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
China
 
NCT01176916
A5991093, NRA5990043
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP