Clinical Trials /

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

NCT01176916

Description:

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Completed

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: Aromasin® Non-Interventional Study Of Early Invasive Breast Cancer Patients In China
  • Official Title: A Prospective Pragmatic Clinical Trial Of China Early Invasive Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin

Clinical Trial IDs

  • ORG STUDY ID: A5991093
  • SECONDARY ID: NRA5990043
  • NCT ID: NCT01176916

Conditions

  • Breast Neoplasms

Interventions

DrugSynonymsArms
Aromasin (exemestane)A

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.

Detailed Description

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

Trial Arms

NameTypeDescriptionInterventions
AOtherThis is a single arm NIS.
  • Aromasin (exemestane)

Eligibility 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®).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:N/A
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

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
Safety Issue:
Description:

Secondary Outcome Measures

Measure:The proportion of subjects experiencing the event
Time Frame:7 years
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:The relationship between Her2 overexpression level and time-to-event
Time Frame:7 years
Safety Issue:
Description:
Measure:The incidence of adverse events and discontinuation of Aromasin® due to adverse event
Time Frame:7 years
Safety Issue:
Description:

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Pfizer

Trial Keywords

  • breast cancer
  • Aromasin
  • adjuvant chemotherapy
  • endocrine therapy

Last Updated

April 17, 2018