Ignite Creation Date:
2024-05-06 @ 8:46 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02812277
Status:
UNKNOWN
Last Update Posted:
2016-06-24
First Post:
2016-05-15
Brief Title:
Retrospective Analysis of Effectiveness and Safety Profile of Anastrozole and Letrozole in HR Breast Cancer Patients
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
Retrospective Analysis of Effectiveness and Safety Profile of Anastrozole and Letrozole in Adjuvant Treatment of HR Early Breast Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2016-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 dataAll the enrolled patients received breast-conserving surgery or whole breast surgery and afterwards received adjuvant chemotherapy according the pathological types The patients 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-25T value-1 indicates mild osteoporosis T value -25 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 DBILUREA 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None