Retrospective Analysis of Effectiveness and Safety Profile of Anastrozole and Letrozole in HR+ Breast Cancer Patients
21 juni 2016 uppdaterad av: Tianjin Medical University Cancer Institute and Hospital
Retrospective Analysis of Effectiveness and Safety Profile of Anastrozole and Letrozole in Adjuvant Treatment of HR+ Early Breast Cancer Patients
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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Förväntat)
1000
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
60 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Testmetod
Sannolikhetsprov
Studera befolkning
This is a single centre, observational and retrospective clinical study.The study group was about all HR positive postmenopausal breast cancer patients,and ever accepted AI therapy with the completed follow-up data.
The patient's clinical pathological data include the age, family history, surgery options, pathologic type,et al.
We analyzed the patients' bone density changes, liver function and kidney function changes,and analyzed the patients' blood-lipoids each half year for 3 years, the occurrence rates of adverse reactions, 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.
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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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.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Compare the proportion of patients with abnormal biochemical test results including liver function, kidney function, blood-lipoids, bone density index.
Tidsram: one year
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one year
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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To explore the proportion of patients discontinue AI treatment and reasons related to these discontinuation.
Tidsram: one year
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one year
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To explore the 3-year DFS rate among the people under upfront therapy.
Tidsram: one year
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one year
|
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To explore the 3-year OS rate among the people under upfront therapy.
Tidsram: one year
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one year
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To explore the DFS in the patients who quit treating.
Tidsram: one year
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one year
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To explore the OS in the patients who quit treating.
Tidsram: one year
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one year
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2016
Primärt slutförande (Förväntat)
1 juli 2017
Avslutad studie (Förväntat)
1 november 2017
Studieregistreringsdatum
Först inskickad
15 maj 2016
Först inskickad som uppfyllde QC-kriterierna
21 juni 2016
Första postat (Uppskatta)
24 juni 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
24 juni 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 juni 2016
Senast verifierad
1 april 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- bc2015014
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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