- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02506361
Evaluation of the Relationship of TOP2α Expression and Effect of Non Dose-dense Chemotherapy for Breast Cancer
21 juli 2015 uppdaterad av: Tianjin Medical University Cancer Institute and Hospital
Evaluation of the Relationship of TOP2α Expression and Effect of Anthracyclines Followed Taxanes or Contains no Taxanes Non Dose-dense Chemotherapy for Breast Cancer: a Prospective, Non-interventional, Multicentre Trail
This is a prospective、multicenter、non-comparative interventional case series.
800 breast cancer patients who have already received chemotherapy prior to this study will be enrolled in the group, including 400 patients received the anthracyclines followed taxanes chemotherapy, and the other 400 patients who have received regiments containing no taxanes.
Three tumor tissue slices of all the enrolled patients will be collected for TOP2α assay.
Meanwhile, 10 years followed-up survey will be conducted.
The relationship of TOP2α expression and 5- year or 10-year disease free survival(DFS) and overall survival(OS)will be identified in this study.
Studieöversikt
Status
Rekrytering
Betingelser
Detaljerad beskrivning
800 breast cancer patients who have received chemotherapy prior to this study will be enrolled in the group, including 400 patients received the anthracyclines followed taxanes chemotherapy(Epirubicin 90 mg/m2 d1, Cyclophosphamide 600mg/m2 d1,21days/cycle, 4 cycles, followed by Docetaxel 75mg/m2,d1, 21days/cycle, 4 cycles;or paclitaxel:Epirubicin 90 mg/m2 d1 cyclophosphamide 600mg/m2 d1, 21day/cycle, 4 cycles, followed by paclitaxel 80mg/m2, weekly, 12 wks), and the other 400 patients who have received regiments containing no taxanes (FEC:5-FU 600mg/m2 d1,Epirubicin 90mg/m2 d1, Cyclophosphamide 500mg/m2 d1, 21day/cycle, 6 cycles; or EC: Epirubicin 90mg/m2 d1, Cyclophosphamide 500mg/m2 d1,21 day/cycle, 6 cycles).The patients will be enrolled in the groups within one month after chemotherapy.Three tumor tissue slices of all the enrolled patients will be collected for TOP2α assay.
Meanwhile, 10 years followed-up survey will be conducted.
The relationship of TOP2α expression and 5-year or 10-year disease free survival(DFS) and overall survival(OS)will be identified in this study.
Studietyp
Observationell
Inskrivning (Förväntat)
800
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Jin Zhang, Pro.
- Telefonnummer: 2901 86-022-23340123
- E-post: zhangjin@tjmuch.com
Studieorter
-
-
-
Tianjin, Kina, 300060
- Rekrytering
- Jin Zhang
-
Underutredare:
- Jin Zhang, Pro.
-
Kontakt:
- Jin Zhang, Pro.
- Telefonnummer: 2901 86-022-23340123
- E-post: zhangjin@tjmuch.com
-
-
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
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Testmetod
Sannolikhetsprov
Studera befolkning
800 breast cancer patients who have already received chemotherapy prior to this study will be enrolled in the group, including 400 patients who have received the anthracyclines followed taxanes chemotherapy, and the other 400 patients have received regiments containing no taxanes.
Beskrivning
Inclusion Criteria:
For inclusion in the study, subjects must fulfil all of the following criteria:
- . Signed and dated informed consent indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
- . Invasive breast cancer confirmed by histology or cytology with the tumor complete resection.
- . Patients without remote organs metastasis.
- . The Ages of patients ≥ 18 years and ≤70 years.
- . Patients with positive axillary lymph nodes, or negative axillary lymph nodes plus one of these conditions: Triple-negative breast cancer, HER- 2(+),Ki-67≥15%.
- . The values of aspartate aminotransferase(AST),alanine aminotransferase(ALT), alkaline phosphatase(ALP), total bilirubin(TBIL), UREA, CREA were less than 2 times of upper limits of normal at the beginning of aromatase inhibitors(AIs) therapy.
- . TOP2α is available to be detected in the primary tumour tissue.
- . Patients received the regimens of anthracyclines followed Taxanes or containing no Taxanes non-dose dense chemotherapy suggested by the guidelines of National Comprehensive Cancer Network (NCCN) 2014.
Exclusion Criteria:
Any of the following is regarded as a criterion for exclusion from the study:
- . Patients is in the period of pregnancy or lactation.
- . Bilateral breast cancer, inflammatory breast cancer or carcinoma in situ.
- . Previous received neo-adjuvant therapy, including chemotherapy, radiotherapy or endocrinotherapy.
- . Presence of other life-threatening cancers.
- . Any severe concomitant condition: 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
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
TOP2αexpressions of participants
Tidsram: one year
|
The TOP2αexpression levels of the 800 enrolled patients tissue samples will be assayed by immunohistochemistry
|
one year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Disease Free Survival time of participants
Tidsram: ten year
|
Ten years followed-up survey will be conducted to identify the 5-year and 10-year Disease Free Survival time of participants.
|
ten year
|
|
Overall Survival time of participants
Tidsram: ten year
|
Ten years followed-up survey will be conducted to identify the 5-year and 10-year Overall Survival time of participants.
|
ten 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 maj 2015
Primärt slutförande (Förväntat)
1 maj 2025
Avslutad studie (Förväntat)
1 oktober 2025
Studieregistreringsdatum
Först inskickad
8 juni 2015
Först inskickad som uppfyllde QC-kriterierna
21 juli 2015
Första postat (Uppskatta)
23 juli 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
23 juli 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 juli 2015
Senast verifierad
1 maj 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- E2014168
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .