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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01176916
Recruitment Status : Recruiting
First Posted : August 6, 2010
Last Update Posted : June 12, 2018
Information provided by (Responsible Party):

August 4, 2010
August 6, 2010
June 12, 2018
February 9, 2011
December 1, 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 ]
Same as current
Complete list of historical versions of study NCT01176916 on Archive Site
  • The proportion of subjects experiencing the event [ Time Frame: 7 years ]
  • 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 ]
  • The relationship between Her2 overexpression level and time-to-event [ Time Frame: 7 years ]
  • The incidence of adverse events and discontinuation of Aromasin® due to adverse event [ Time Frame: 7 years ]
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
Phase 4
Masking: None (Open Label)
Breast Neoplasms
Drug: Aromasin (exemestane)
This is a NIS, the dosage, frequency and duration base on the LPD approved by SFDA.
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 Identifier (NCT Number) in Medline.
Same as current
December 1, 2018
December 1, 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®).
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Child, Adult, Older Adult
Contact: Pfizer Call Center 1-800-718-1021
NRA5990043 ( Other Identifier: Alias Study Number )
Not Provided
Not Provided
Not Provided
Study Director: Pfizer Call Center Pfizer
June 2018

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