- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02812277
Retrospective Analysis of Effectiveness and Safety Profile of Anastrozole and Letrozole in HR+ Breast Cancer Patients
Retrospective Analysis of Effectiveness and Safety Profile of Anastrozole and Letrozole in Adjuvant Treatment of HR+ Early Breast Cancer Patients
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
1). Breast cancer confirmed by histology or cytology with the tumor complete resection 2). ER and /or PR positive 3). Postmenopausal woman, defined as a woman fulfilling any 1 of the following criteria (based on the NCCN definition of menopause [National Comprehensive Cancer Network 2008]):
- Prior bilateral oophorectomy;
- Age ≥ 60 years;
Age < 60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and plasma FSH and estradiol in the postmenopausal range; if taking tamoxifen or toremifene, and age<60 years, then serial measurement of plasma FSH and estradiol are need to ensure in the postmenopausal ranges.
4). Patients have received regular anastrozole or letrozole adjuvant treatment 6). The values of AST, ALT, ALP, TBIL, UREA, CREA were less than 2 times of ULN at the beginning of AI therapy.
7). BMD T >-1 at baseline.
Exclusion Criteria:
Any of the following is regarded as a criterion for exclusion from the study:
- . Previous use of the other AIs except for anastrozole or letrozole
- . Any severe concomitant condition before AI treatment: uncontrolled cardiac disease or uncontrolled diabetes mellitus et al.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Anastrozole treatment group
The study group was about HR positive postmenopausal breast cancer patients who were hospitalized between January, 2008 and October, 2010, and ever accepted anastrozole therapy with the completed follow-up data.
|
letrozole treatment group
The study group was about HR positive postmenopausal breast cancer patients who were hospitalized between January, 2008 and October, 2010, and ever accepted letrozole therapy with the completed follow-up data.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compare the proportion of patients with abnormal biochemical test results including liver function, kidney function, blood-lipoids, bone density index.
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To explore the proportion of patients discontinue AI treatment and reasons related to these discontinuation.
Time Frame: one year
|
one year
|
To explore the 3-year DFS rate among the people under upfront therapy.
Time Frame: one year
|
one year
|
To explore the 3-year OS rate among the people under upfront therapy.
Time Frame: one year
|
one year
|
To explore the DFS in the patients who quit treating.
Time Frame: one year
|
one year
|
To explore the OS in the patients who quit treating.
Time Frame: one year
|
one year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- bc2015014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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