- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04639271
Pyrotinib, Trastuzumab And Abraxane in HER2-positive MBC With Brain Metastasis
A Single-arm, Open-label Study Of Pyrotinib Combined WithTrastuzumab And Abraxane in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Overexpression of HER2 is associated with increased incidence of brain metastases in breast cancer, accounting for about 20-50% of HER2 positive breast cancer. Treatment strategy ranged from local therapies to systemic anti-HER2 therapies, prognosis of patients with brain metastases remains poor. Previous clinical trials had demonstrated the efficacy of trastuzumab and TKIs for brain metastasis.
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. We designed the study to explore the efficacy and safety of pyrotinib combined with trastuzumab and abraxane in HER2-positive MBC with brain metastasis.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Shandong
-
Jinan, Shandong, Chine
- Zhiyong Yu
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Aged >18 years.
- ECOG performance status ≤2.
- Histologically or cytologic confirmed HER2 positive advanced breast cancer.
- MRI confirmed brain metastases. According to RECIST 1.1, at least one measurable lesion exists.
- No limit of previous chemotherapy lines.
- Previously have not reveived capecitabine or disease progression of capecitabine after 6 months, or progression of capecitabine adjuvant therapy after one year;
- Life expectancy of more than 3 months.
- Required laboratory values including following parameters: ANC: ≥ 1.5 x 10^9/L;Platelet count: ≥ 100 x 10^9/L;Hemoglobin: ≥ 9.0 g/dL;Total bilirubin: ≤ 1.5 x upper limit of normal (ULN);ALT and AST: ≤ 1.5 x ULN (or ≤ 5×ULN in patients with liver metastases);BUN and creatine clearance rate: ≥ 50 mL/min;LVEF: ≥ 50%;QTcF: < 470 ms for female and < 450 ms for male.
- Signed the informed consent form prior to patient entry.
Exclusion Criteria:
- Patients with brain metastases who have extensive meningeal metastases and are treated with hormone dehydration.
- Subjects with third space fluid(such as a large amount of pleural effusion and ascites) that can not be controled by drainage or other methods. (such as pleural effusion and ascites).
- Received whole brain radiotherapy, chemotherapy, surgery or target therapy within 2 weeks prior to randomization. Received hormone therapy within 1 weeks prior to randomization, Received the nitrosoureas or mitomycin chemotherapy within 6 weeks prior to randomization.
- Participated in other clinical trial within 4 weeks prior to randomization.
- Treated or treating with HER2 tyrosine kinase inhibitors (TKIs) (including Lapatinib, Neratinib and Pyrotinib).
- Second malignancies within 5 years, except for cured carcinoma in-situ of uterine cervix, skin basal cell carcinomaand squamous-cell carcinoma.
- Receiving any other anti-tumor therapies at time of study screening visit.
- There are no other serious and/or uncontrolled diseases that may affect research participation, including any of the following: (1) unable to swallow, chronic diarrhea and intestinal obstruction and factors influencing the usage of oral administration; (2) has allergies or a known history of hypersensitivity to the drug components of this program; History of Immunodeficiency, acquired or congenital immunodeficiency (HIV positive) ,history of organ transplantation; (3) History of any kind of Heart disease, including 1) Myocardial infarction; 2) Heart failure; 3) Any other heart disease judged by researcher as not suitable for participating in this study, etc; (4) Infection.
- All female patients in breastfeeding period or in child-bearing period or with positive pregnancy test result or refusing to take a reliable method of birth control during the study.
- Any other situations judged by investigator as not suitable for participating in this study.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Pyrotinib Plus Trastuzumab And Abraxane
|
Pyrotinib::400mg/d,qd,po
8 mg/kg intravenously (IV) on Day 1 of Cycle 1, followed by 6 mg/kg on Day1 of each 21-day cycle
Abraxane 125mg/M2, qw iv
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Objective Response Rate (ORR) of Intracranial Lesion
Délai: Estimated up to 1 year
|
Refers to the proportion of patients whose Intracranial Lesion have shrunk to a certain proportion and maintained for a certain period of time, including cases of CR and PR, RECIST 1.1 were used to assess objective tumor remission
|
Estimated up to 1 year
|
Progression Free Survival(PFS) of Intracranial Lesion
Délai: Estimated up to 1 year
|
the date from the first dose to the first occurrence of Intracranial Lesion progression or death from any cause, whichever occurs first
|
Estimated up to 1 year
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Progression Free Survival(PFS)
Délai: Estimated up to 1 year
|
the date from the first dose to the first occurrence of disease progression or death from any cause, whichever occurs first
|
Estimated up to 1 year
|
Objective Response Rate (ORR)
Délai: Estimated up to 1 year
|
Refers to the proportion of patients whose lesion have shrunk to a certain proportion and maintained for a certain period of time, including cases of CR and PR, RECIST 1.1 were used to assess objective tumor remission
|
Estimated up to 1 year
|
disease control rate(DCR)
Délai: Estimated up to 1 year
|
Percentage of confirmed complete remission (CR), partial remission (PR), and disease stable (SD) cases in patients with evaluable efficacy
|
Estimated up to 1 year
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Maladies de la peau
- Tumeurs
- Tumeurs par site
- Maladies du sein
- Tumeurs du système nerveux central
- Tumeurs du système nerveux
- Tumeurs mammaires
- Tumeurs cérébrales
- Agents antinéoplasiques
- Agents antinéoplasiques immunologiques
- Trastuzumab
- Paclitaxel lié à l'albumine
Autres numéros d'identification d'étude
- ShandongCHI-16
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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