- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01370239
HumanaH - Hu3s193 in the Treatment of Advanced Breast Cancer After Hormonal Therapy
9 octobre 2019 mis à jour par: Paulo Marcelo Gehn Hoff, Instituto do Cancer do Estado de São Paulo
A Multicenter Phase II Study of Treatment With Hu3S193 in Women With Advanced Breast Cancer That Progressed After Hormonal Therapy
The humanized monoclonal antibody against Lewis Y antigen (Hu3S193) has been demonstrated to be safe in previous studies and has also been indicated as potential intervention in breast cancer.
The study of this new agent in advanced breast cancer may contribute to the development of new strategies for patients that progressed after hormonal treatment.
Aperçu de l'étude
Description détaillée
This is a national study, open label, single arm, phase II study which will be conducted in seven centers in Brazil.
The study will be coordinated by the INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO in collaboration with RECEPTA Biopharma.
The study is funded by the CONSELHO NACIONAL DE DESENVOLVIMENTO CIENTÍFICO E TECNOLÓGICO (CNPq).
Before any procedure relating to the study, patients must read and sign the informed consent (IC).
The inclusion of patients begin immediately after regulatory approval and is expected to end after reaching the number of patients.
The follow-up term will last at least 24 months for each patient included, unless limited by death, loss to follow up or withdrawal of informed consent.
A total of 60 patients will be recruited in this study.
The eligible patients must be 18 or older, confirmed diagnosis of breast cancer with locally advanced or metastatic progression after one or two lines of previous hormone treatment, confirmation of Lewis antigen expression -as assessed by central laboratory, measurable or evaluable disease and adequate organ function.
Patients will receive weekly intravenous doses of the antibody Hu3S193 until disease progression, unacceptable toxicity, withdrawal of consent or the investigator's decision, whichever occurs first.
The study's primary endpoint is the clinical benefit rate.
Type d'étude
Interventionnel
Inscription (Réel)
23
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Goias, Brésil
- Universidade Federal de Goias
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Rio de Janeiro, Brésil
- Instituto Nacional do Cancer
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Sao Paulo, Brésil, 01246-000
- Instituto do Cancer do Estado de São Paulo
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Sao Paulo, Brésil
- Hospital Sirio Libanes
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Ceará
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Fortaleza, Ceará, Brésil
- Universidade Federal do Ceara
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RIO Grande DO SUL
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Porto Alegre, RIO Grande DO SUL, Brésil
- Pontificia Universidade Católica do Rio Grande do Sul
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SÃO Paulo
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Barretos, SÃO Paulo, Brésil
- Hospital do Cancer de Barretos
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
Inclusion Criteria:
- Diagnosis of breast cancer with locally advanced or metastatic (stages IIIB, IIIC or IV according to TNM classification), confirmed histologically with no intention to curative treatment by radiotherapy or surgery;
- Clinical or radiological progression after one or two lines of previous hormone treatment, including adjuvant treatment;
- Positive for ER and / or PR expression documented by IHC;
- Confirmed expression of Lewis Y antigen by IHC;
- Presenting the performance status of 0 or 1 according to Eastern Cooperative Oncology Group (ECOG);
- Have a measurable or evaluable disease by Response of Evaluation Criteria in Solid Tumors (RECIST);
- Adequate organ function, assessed by laboratory tests obtained at least 2 weeks before the first day of treatment and within the following parameters:
absolute neutrophil count ≥ 1.5 x 109 / L; platelet count ≥ 100 x 109 / L; serum bilirubin ≤ 2.0 mg / dL; AST/ALT ≤ 2.5 x upper limit of normal; serum creatinine ≤ 2.0 mg / dL;
- Expected survival > 12 weeks;
- In patients with childbearing potential: Negative pregnancy confirmed by test done 21 days before the date of study treatment initiation;
- Willingness and ability to comply with the protocol for the duration of the study.
Exclusion Criteria:
- Patients subjected previously to more than two lines of hormonal therapy, including adjuvant treatment;
- Presenting the amplification or overexpression of HER-2;
- Systemic corticosteroids or immunosuppressive agents used concomitantly with the study or have used systemic corticosteroids or immunosuppressants in the last 14 days before the first dose of the investigational drug;
- Visceral metastatic disease with life-threatening (as defined by extensive liver involvement), or symptomatic pulmonary lymphangitic carcinomatosis or any degree of cerebral or leptomeningeal involvement;
- Previous or current history of clinically significant cardiac disease (class III or IV according to New York Heart Association);
- Clinically significant arrhythmia;
- History of myocardial infarction within the last 6 months;
- Previous or current history of other severe diseases (eg, severe ascites requiring repeated drainage, active infections requiring antibiotics, bleeding, inflammatory bowel disease or chronic diseases that may interfere with obtaining accurate results of the study);
- Previous chemotherapy for metastatic disease (adjuvant chemotherapy is acceptable, if more than four weeks between its completion and inclusion in the study;
- Radiotherapy within 4 weeks before inclusion in the study or with no recovery from the toxic effects of radiotherapy when done up to 6 weeks before inclusion in the study, except for palliative radiotherapy for bone metastases involving <25 % bone marrow;
- Treatment with biological agents, immunotherapy or surgery within 4 weeks before inclusion in the study or with no recovery from the toxic effects of these treatments when made until six weeks prior to study entry (prior treatment with bisphosphonates is allowed, it can be continued after inclusion in the study);
- Any investigational agent treatment within 12 months prior to study entry, unless the investigator considers that the participation in the study may benefit the patient;
- Previous or current history of another type of tumor, excluding skin cancer, melanoma, in situ cervix carcinoma or in situ ductal carcinoma or lobular breast if properly treated;
- Uncontrolled hypercalcemia (defined as total calcium> 11.5 mg / dL)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
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 |
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Expérimental: Hu3S193
Single arm
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Patients will receive weekly intravenous doses of 20 mg/m2 of the antibody Hu3S193.
The infusion will take 60 ± 10 minutes.
The antibody should be diluted in 500 mL of normal saline.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Complete response, partial response or stable disease.
Délai: more than 24 weeks
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The primary efficacy analysis will be done through the clinical benefit rate, as defined by the proportion of patients achieving best response, complete response, partial response or stable disease for more than 24 weeks
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more than 24 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Response rate
Délai: 24 weeks after patient discontinuation (at minimum)
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from inclusion until disease progression or death
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24 weeks after patient discontinuation (at minimum)
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Non progression rate
Délai: 24 weeks after patient discontinuation (at minimum)
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From patient inclusion until disease progression or death - evaluated radiologically by CT
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24 weeks after patient discontinuation (at minimum)
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Overall survival
Délai: 24 weeks after patient discontinuation (at minimum) or until death
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until death
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24 weeks after patient discontinuation (at minimum) or until death
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Progression free survival
Délai: until disease progression or 24 weeks after patient discontinuation (at minimum)
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Evaluated radiologically by CT
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until disease progression or 24 weeks after patient discontinuation (at minimum)
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Assessment of any sign, symptom or undesirable medical condition that occurs after the first administration of the investigational agent
Délai: Until disease progression or 30 days after patient discontinuation
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Until disease progression or 30 days after patient discontinuation
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Directeur d'études: PAULO MG HOFF, MD Professor, Instituto do Cancer do Estado de São Paulo
- Directeur d'études: SERGIO V SERRANO, MD, Hospital do Cancer de Barretos
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 novembre 2013
Achèvement primaire (Réel)
1 octobre 2015
Achèvement de l'étude (Réel)
25 mai 2018
Dates d'inscription aux études
Première soumission
25 mai 2011
Première soumission répondant aux critères de contrôle qualité
8 juin 2011
Première publication (Estimation)
9 juin 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 octobre 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 octobre 2019
Dernière vérification
1 octobre 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 52/2009
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
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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