- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Detaljert beskrivelse
Studietype
Registrering (Forventet)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
---|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Compare the proportion of patients with abnormal biochemical test results including liver function, kidney function, blood-lipoids, bone density index.
Tidsramme: one year
|
one year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
To explore the proportion of patients discontinue AI treatment and reasons related to these discontinuation.
Tidsramme: one year
|
one year
|
To explore the 3-year DFS rate among the people under upfront therapy.
Tidsramme: one year
|
one year
|
To explore the 3-year OS rate among the people under upfront therapy.
Tidsramme: one year
|
one year
|
To explore the DFS in the patients who quit treating.
Tidsramme: one year
|
one year
|
To explore the OS in the patients who quit treating.
Tidsramme: one year
|
one year
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- bc2015014
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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