- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02489409
Recombinant Human Endostatin (EndostarTM) Injection in Treatment of Recurrent Metastatic Breast Cancer
12 juli 2017 uppdaterad av: Shun-E Yang, Xinjiang Medical University
EndostarTM Injection Combined With Gemcitabine+Platinum (GP)/Navelbine+Platinum (NP)/Gemcitabine+Xeloda (GX)/Navelbine+Xeloda (NX) in Treatment of Recurrent Metastatic Breast Cancer: A Randomized, Opened and Controlled Clinical Study
Endostatin has been widely applied for the clinical treatment of partial primary and metastatic solid tumors.
Endostatin combined with chemotherapy has achieved favorable progression in the treatment of non-small cell lung cancer (NSCLC).
However, the research about the efficacy of Endostatin on breast cancer has just started.
Breast cancer is a highly-differentiated solid tumor, indicating that it is also an indicator for Endostatin therapy.
Additionally, after chemo- and radiotherapy, the primary nidi of patients with advanced breast cancer may also lead to rapid development of tumors in other locations.
So Endostatin combined with chemotherapy can also improve the prognosis of patients with recurrent metastatic breast cancer, but there is rare any report at home and abroad.
To further explore the above research, this study designed a randomized, opened and controlled clinical study to observe the clinical efficacy of EndostarTM Injection combined with GP/NP/GX/NX in the treatment of recurrent metastatic breast cancer.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Large amounts of studies have proved that the development of tumor vessels mainly depend on the activation, proliferation, adhesion and maturity of vascular endothelial cells, which may also become the targets of vascular inhibitors.
At present, Avastin, an anti-angiogenesis drug, has been marketed in Euopean and American countries, and another 30 kinds of vascular inhibitors are still in trails.
Endostatin has been widely applied for the clinical treatment of partial primary and metastatic solid tumors.
Endostatin combined with chemotherapy has achieved favorable progression in the treatment of non-small cell lung cancer (NSCLC).
However, the research about the efficacy of Endostatin on breast cancer has just started.
Breast cancer is a highly-differentiated solid tumor, indicating that it is also an indicator for Endostatin therapy.
Additionally, after chemo- and radiotherapy, the primary nidi of patients with advanced breast cancer may also lead to rapid development of tumors in other locations.
So Endostatin combined with chemotherapy can also improve the prognosis of patients with recurrent metastatic breast cancer, but there is rare any report at home and abroad.
To further explore the above research, this study designed a randomized, opened and controlled clinical study to observe the clinical efficacy of EndostarTM Injection combined with GP/NP/GX/NX in the treatment of recurrent metastatic breast cancer.
Studietyp
Interventionell
Inskrivning (Förväntat)
120
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Xinjiang
-
Urumchi, Xinjiang, Kina, 830000
- Rekrytering
- Third Affiliated Hospital of Xinjiang Medical University
-
Kontakt:
- Shun-E Yang, Professor
- Telefonnummer: 15805197983
- E-post: 319889719@qq.com
-
Kontakt:
- Xun Li, Assistant
- Telefonnummer: 7819371 0991-7819372
- E-post: yangshune@medmail.com.cn
-
-
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
Beskrivning
Inclusion Criteria:
- Age: 18~70 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0~1 score;
- All patients were diagnosed as recurrent metastatic breast cancer retreatment by histopathology and computed tomography (CT) examination;
- The measurable nidus≥1: Patients whose nidus diameter ≥ 20 mm by normal CT or magnetic resonance image (MRI) scanning, and ≥ 10 mm by spiral CT scanning;
- Patients whose blood routine, hepatorenal function, electrolyte and cardiac function were basically normal without dysfunction of primary organs. White blood cell count (WBC) ≥4.0×109/L, neutrophile granulocyte count ≥1.5×109/L, platelet (PLT) count ≥100×109/L, hemoglobin (HGB) ≥95 g/L, serum bilirubin (BIL) ≤1.5-fold upper limit of normal value, alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤2-fold upper limit of normal value, and serum creatinine (Scr) ≤1.5mg/dl;
- The expected survival time >3 months;
- Patients who could understand this study status and had signed the informed consent forms.
Exclusion Criteria:
- Patients who had history of allergic responses to biological agents;
- Patients who were receiving other anti-tumor therapies;
- Patients without measureable nidus;
- Others, including one of the following conditions: patients with uncontrolled central nervous system (CNS) metastatic nidi, with dysfunction of important organs and severe cardiac diseases (congestive heart failure, uncontrollable arrhythmia, and angina pectoris, valvular heart disease, myocardial infarction and refractory hypertension that required long-term drug administration), with chronic infectious wound and with history of uncontrollable psychosis, and women in pregnant or lactation period.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Experimental group
Gemcitabine (Gem): 1.0 m/m2, iv 0.5h, d1, 8; Navelbine (NVB): 40 mg/d, iv, d1, 8; Platinum (DDP): 30 mg/m2, iv 3h, d1-3; Xeloda Tablets: 2 000 mg/m2, po, d1-14; EndostarTM Injection: 210 mg in 279 mL normal saline (NS), continuous pump, d1-d10 (2.5 mL/h).
|
210 mg in 279 mL normal saline (NS), continuous pump, d1-d10 (2.5 mL/h)
Andra namn:
1.0 m/m2, iv 0.5h, d1, 8
Andra namn:
40 mg/d, iv, d1, 8
Andra namn:
30 mg/m2, iv 3h, d1-3
Andra namn:
2 000 mg/m2, po, d1-14
Andra namn:
|
Aktiv komparator: Control group
Gemcitabine (Gem): 1.0 m/m2, iv 0.5h, d1, 8; Navelbine (NVB): 40 mg/d, iv, d1, 8; Platinum (DDP): 30 mg/m2, iv 3h, d1-3; Xeloda Tablets: 2 000 mg/m2, po, d1-14.
|
1.0 m/m2, iv 0.5h, d1, 8
Andra namn:
40 mg/d, iv, d1, 8
Andra namn:
30 mg/m2, iv 3h, d1-3
Andra namn:
2 000 mg/m2, po, d1-14
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
response rate
Tidsram: 2 years
|
response rate that defined as the total ratio of study subjects with complete response, complete response unconfirmed and partial response after treatment.
ORR=(CR+ CRu+ PR)cases/total cases×100%.
|
2 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
clinical benefit rate
Tidsram: 2 years
|
clinical benefit rate that defined as the total ratio of study subjects with complete response,partial response and stable disease more than 24 months after treatment.
|
2 years
|
progression-free survival
Tidsram: 2 years
|
Progression-free survival (PFS) defined as the ratio of study subjects who had disease progression or died from the start of randomization.
|
2 years
|
median survival time
Tidsram: 2 years
|
median survival time defined as the corresponding survival time when the cumulative survival rate is 50%.
|
2 years
|
overall survival
Tidsram: 2 years
|
overall survival rate (OS) that defined as the ratio of study subjects who survived after randomization
|
2 years
|
adverse responses
Tidsram: 2 years
|
adverse responses that defined as the evaluated by rates of all adverse reactions caused by Recombinant Human Endostatin and the changes of all indexes before and after treatment
|
2 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Shun-E Yang, Professor, Third Affiliated Hospital of Xinjiang Medical University
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 oktober 2015
Primärt slutförande (Förväntat)
1 maj 2018
Avslutad studie (Förväntat)
1 juli 2018
Studieregistreringsdatum
Först inskickad
1 juli 2015
Först inskickad som uppfyllde QC-kriterierna
1 juli 2015
Första postat (Uppskatta)
3 juli 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juli 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 juli 2017
Senast verifierad
1 juli 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Hudsjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Bröstsjukdomar
- Bröstneoplasmer
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Enzyminhibitorer
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antineoplastiska medel, fytogena
- Angiogeneshämmare
- Angiogenesmodulerande medel
- Tillväxtämnen
- Tillväxthämmare
- Gemcitabin
- Vinorelbin
- Endostatiner
Andra studie-ID-nummer
- XinjiangMU001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
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 .
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