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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The department of surgery at Tian Jin Medical University Cancer Hospital, one of the centers of excellence to treat patients with breast cancer in China, collects and maintains an electronic database of patients treatment details and follow up data. 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.All the enrolled patients received breast-conserving surgery or whole breast surgery, and afterwards, received adjuvant chemotherapy according the pathological types. The patient's clinical pathological data include the age, family history, surgery options, pathologic type, the size of tumor, lymph node status, histological grade, chemotherapy regime, irradiation regime, and the expressions pattern of Her-2 and Ki-67. The research starts when the patients received the first time AI treatment. In the subsequent treatment, we analyzed the patients' bone density changes (T value \>-1 indicates normal,-2.5≤T value≤-1 indicates mild osteoporosis, T value \<-2.5 indicates severe osteoporosis) each half year for 3 years, analyzed the patients' liver function and kidney function changes each half year for 3 years (AST, ALT, ALP, TBIL, DBIL,UREA and CREA values \> 2 times ULN indicates abnormal), analyzed the patients' blood-lipoids (LDL, HDL, TG and TC) each half year for 3 years, the occurrence rates of adverse reactions (skin flush, joint pain, headache, rash, nausea, vomiting, diarrhea, et al), the causes and rates of treatment termination between the 2 groups, the 3 years DFS and OS between two groups, and the factors associated with survival and prognosis, and identified the benefit individuals of AI therapy.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	—	This is a Non-Interventional Study, so there are no drug or devices included.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-07-01
• Completion: 2017-11-01
• First posted: 2016-06-24
• Last updated: 2016-06-24