Clinical trial · Observational
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
NCT02812277CI-TRIAL-00022711unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single centre, observational and retrospective clinical study. The study group was about all HR positive postmenopausal breast cancer patients who were hospitalized between January, 2008 and October, 2010, and ever accepted AI therapy with the completed follow-up data.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Anastrozole treatment group
- description
- 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.
- label
- letrozole treatment group
- description
- 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.
Primary outcomes (1)
- measure
- Compare the proportion of patients with abnormal biochemical test results including liver function, kidney function, blood-lipoids, bone density index.
- timeFrame
- one year
Secondary outcomes (5)
- measure
- To explore the proportion of patients discontinue AI treatment and reasons related to these discontinuation.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
Show eligibility criteria text
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 \[National Comprehensive Cancer Network 2008\]):
1. Prior bilateral oophorectomy;
2. Age ≥ 60 years;
3. 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:
1. . Previous use of the other AIs except for anastrozole or letrozole
2. . Any severe concomitant condition before AI treatment: uncontrolled cardiac disease or uncontrolled diabetes mellitus et al.References
Publications (0)
Data not yet available
No reference posted for this study.