- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01669252
Pharmacogenomic Study of Neoadjuvant Eribulin for HER2 Non-overexpressing Breast Cancer (NeoEribulin)
31 oktober 2017 uppdaterad av: SOLTI Breast Cancer Research Group
A Phase II, Open-label, Single-arm, Exploratory Pharmacogenomic Study of Single Agent Eribulin (HALAVEN®) as Neoadjuvant Treatment for Operable Stage I-II HER2 Non-overexpressing Breast Cancer.
This is a prospective, non-randomized, open-label, multicenter, single-arm exploratory pharmacogenomic study of single agent eribulin as neoadjuvant therapy in patients with operable Stage III HER2 non-overexpressing breast cancer.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
163
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Villejuif, Frankrike, 94800
- Institut Gustave Roussy
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Coimbra, Portugal, 3001-651
- Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE
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Lisboa, Portugal, 1500-650
- Hospital da Luz
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Porto, Portugal, 4200-072
- Instituto Portugues de Oncologia de Porto Francisco Gentil, EPE
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Barcelona, Spanien, 08025
- Hospital de la Santa Creu i Sant Pau
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Barcelona, Spanien
- Hospital Universitario Vall d´Hebron
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Barcelona, Spanien, 08035
- Hospital Universitario Vall d´Hebron
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Castelló de la Plana, Spanien, 12002
- Complejo Hospitalario de Castellón
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Cáceres, Spanien, 10003
- Complejo Hospitalario San Pedro de Alcantara
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Córdoba, Spanien, 14004
- Hospital Universitario Reina Sofia
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Denia, Spanien, 03700
- Hospital Marina Salud de Dénia
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Jaén, Spanien, 23007
- Complejo Hospitalario de Jaén
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Lleida, Spanien, 25198
- Hospital Universitari Arnau de Vilanova de Lleida
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Madrid, Spanien, 28034
- Hospital Universitario Ramón y Cajal
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Madrid, Spanien, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Spanien, 28040
- Hospital Universitario Clinico San Carlos
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Madrid, Spanien, 28222
- Hospital Universitario Puerta de Hierro de Majadahonda
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Murcia, Spanien, 30120
- Hospital Universitario Virgen de la Arrixaca
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Reus, Spanien, 43201
- Hospital Universitari Sant Joan de Reus
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Santiago de Compostela, Spanien, 15706
- Complejo Hospitalario Universitario de Santiago
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Sevilla, Spanien, 41013
- Hospital Universitario Virgen del Rocio
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Sevilla, Spanien, 41007
- Hospital Virgen de la Macarena
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Torrevieja, Spanien, 03186
- Hospital de Torrevieja
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Valencia, Spanien, 46010
- Hospital Clínico Universitario de Valencia
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Valencia, Spanien, 46015
- Hospital Arnau de Vilanova de Valencia
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Zaragoza, Spanien, 50009
- Hospital Universitario Lozano Blesa
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Deggendorf, Tyskland, 94469
- Klinikum des Landkreises Deggendorf Frauenklinik Mammazentrum
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Köln, Tyskland, 51067
- Brustzentrum im Krankenhaus Köln-Holweide Priv. Doz.
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Munic, Tyskland, 81377
- Brustzentrum der Universität München
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Rostock, Tyskland, 18059
- Klinikum Südstadt Rostock, Universitätsfrauenklinik und Poliklinik
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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 och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Written informed consent, specifically highlighting the molecular characterization of tumor and genomic samples
- Age ≥18 years
Histologically confirmed invasive breast carcinoma, with all of the following characteristics:
- Primary tumor ≥2cm in largest diameter (cT1-3)
- cN0-1
- No evidence of distant metastasis (M0)
- Breast cancer (BC) eligible for primary surgery
- Available pre-treatment core (Tru-cut) biopsy or possibility of performing one
HER2-negative BC (as per local assessment), defined as either of the following:
- 0-1+ expression by IHC
- 2+ expression by IHC and in situ hybridization (FISH/CISH) without HER2 gene amplification (<4 HER2 gene copies per nucleus, or a FISH ratio [HER2 gene copies to Cr17 signals] of <1.8)
- Is situ hybridization (FISH/CISH) without HER2 gene amplification, independently of IHC
- Known hormone receptor (ER/PgR) status (as per local assessment) or the possibility of performing the tests
- Known percentage of hormone receptor (ER/PgR) and Ki67-positive tumor cells (as per local assessment), or possibility of performing the tests
- In the case of a multifocal tumor, the largest lesion must be ≥2 cm and designated the "target" lesion for all subsequent tumor evaluations and HER2-negative status must be documented in all the tumor foci
- ECOG performance status of 0 or 1
Laboratory values as follows:
- Absolute neutrophil count (ANC) ≥1.5 x 109/L
- Platelets count ≥100 x 109/L
- Hemoglobin ≥9 g/dL
- Serum bilirubin ≤1.5 time the upper limit of normal (ULN)
- Alanine aminotransferase and aspartate aminotransferase (AST) ≤2.5 x ULN
- Alkaline phosphatase ≤2.5 x ULN
- Serum creatinine ≤1.5 mg/dL or calculated creatinine clearance ≥60 mL/m
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol
- Availability of genomic DNA (via whole blood)
Exclusion Criteria:
- Any prior treatment for primary invasive BC
- Metastatic, locally advanced or inflammatory (i.e., Stage III-IV) BC
- Bilateral invasive BC
- Multicentric BC, defined as the presence of two or more foci of cancer in different quadrants of the same breast
- Pre-existing peripheral neuropathy of any grade
- Uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg)
- Clinically significant (i.e., active) cardiovascular disease
- Long QT syndrome
- Concomitant use of inhibitors of hepatic transport proteins such as organic anion-transporting proteins, P-glycoprotein, multidrug resistant proteins etc
- Major medical conditions that might affect study participation (e.g., uncontrolled seizure disorder, uncontrolled pulmonary, renal or hepatic dysfunction, or uncontrolled infection)
- Other primary malignant tumors within the previous 5 years, except for adequately controlled limited basal cell carcinoma of the skin or carcinoma in situ of the cervix
- Known human immunodeficiency virus(HIV) infection or other active or serious infection requiring IV antibiotics at randomization
- Pregnancy or breastfeeding women
- Women of childbearing potential(<2 years after the last menstruation) not using effective, non-hormonal means of contraception during the study and for a period of 6 months following the last administration of study drug
- Administration of any live virus vaccine within 8 weeks preceding study entry
- Use of any investigational agent within 30 days of administration of the first dose of study drug or concurrent treatment on another clinical study
- Requirement for radiation therapy concurrent with study anticancer treatment
- Known hypersensitivity to any of the study drugs or excipients
- Inability or unwillingness to abide by the study protocol or cooperate fully with the investigator or designee
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: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Eribulin
1.23 mg/m2 eribulin ready to use solution (equivalent to 1.4 mg/m2 eribulin mesilate) IV on Days 1 and 8 of every 21-day cycle, for 4 cycles.
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1.23 mg/m2 eribulin ready to use solution (equivalent to 1.4 mg/m2 eribulin mesilate) IV on Days 1 and 8 of every 21-day cycle, for 4 cycles.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Correlation of pre-treatment relative abundance of hundreds of mRNA transcripts from primary breast tumors with pCRB after neoadjuvant treatment with eribulin.
Tidsram: At the time of definitive surgery.
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pCRB , defined as the complete absence of invasive carcinoma in the breast on histological examination at the time of definitive surgery, according to the NSABP guidelines
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At the time of definitive surgery.
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Sekundära resultatmått
Resultatmått |
Tidsram |
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Rate of pCRB, defined as the complete absence of invasive carcinoma in the breast on histological examination at the time of definitive surgery, according to the NSABP guidelines.
Tidsram: At the time of definitive surgery
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At the time of definitive surgery
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Rate of pCRBL, defined as the complete absence of invasive carcinoma in the breast and axillary lymph nodes on histological examination at the time of definitive surgery.
Tidsram: At the time of definitive surgery
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At the time of definitive surgery
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Clinical and radiological ORR, defined by RECIST 1.1
Tidsram: At the time of definitive surgery
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At the time of definitive surgery
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Correlation of mRNA expression in breast tumors with clinical and radiological ORR at different time points during the neoadjuvant treatment with eribulin.
Tidsram: Up to 21 weeks
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Up to 21 weeks
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Rate of pCRB according to breast cancer subtype: Luminal A, Luminal B, Basal-like, HER2-enriched and Claudin-low.
Tidsram: At the time of definitive surgery
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At the time of definitive surgery
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Rate of pCRB according to breast cancer subtype determined by immunohistochemistry (following the 2011 St. Gallen definitions): Luminal A, Luminal B, and TNBC.
Tidsram: At the time of definitive surgery
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At the time of definitive surgery
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Proportion of patients able to have breast conservation surgery after being treated with eribulin as neoadjuvant therapy.
Tidsram: At the time of definitive surgery
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At the time of definitive surgery
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The correlation between alternations in tubulin isotype expression and mutational status in pre-treatment samples with efficacy parameters, such as pCRB, ORR and BOR.
Tidsram: At the time of definitive surgery
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At the time of definitive surgery
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The correlation between exome or genome sequencing data from pre-treatment samples with pCRB after neoadjuvant treatment with eribulin.
Tidsram: At the time of definitive surgery
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At the time of definitive surgery
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Changes in gene expression and gene mutational status between the pre-treatment samples and samples after treatment.
Tidsram: At the time of definitive surgery
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At the time of definitive surgery
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Number of participants with AEs and serious AEs (assessed by CTCAE v.4)
Tidsram: Up to 21 weeks
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Up to 21 weeks
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Percentage of patients who had neutropenia Grade 3-4
Tidsram: Up to 21 weeks
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Up to 21 weeks
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Percentage of subjects with neuropathy
Tidsram: Up to 21 weeks
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Up to 21 weeks
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Incidence of dose reductions and/or dose delays due to treatment toxicity
Tidsram: Up to 71 days
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Up to 71 days
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Analysis of the expression of mRNA from breast tumors
Tidsram: At screening
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At screening
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Analysis of the expression of mRNA from breast tumors
Tidsram: At 21 days
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At 21 days
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Analysis of the expression of mRNA from breast tumors
Tidsram: At the time of definitive surgery
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At the time of definitive surgery
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Correlation of mRNA expression in breast tumors after 21 days of neoadjuvant treatment and at surgery with pCRB.
Tidsram: At the time of definitive surgery
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At the time of definitive surgery
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Sensitivity of the gene expression analysis of samples to predict clinical response to eribulin.
Tidsram: At screening
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At screening
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Sensitivity of the gene expression analysis of samples to predict clinical response to eribulin.
Tidsram: At 21 days
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At 21 days
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Sensitivity of the gene expression analysis of samples to predict clinical response to eribulin.
Tidsram: At time of definitive surgery
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At time of definitive surgery
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Specificity of the gene expression analysis of samples to predict clinical response to eribulin.
Tidsram: At screening
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At screening
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Specificity of the gene expression analysis of samples to predict clinical response to eribulin.
Tidsram: At 21 days
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At 21 days
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Specificity of the gene expression analysis of samples to predict clinical response to eribulin.
Tidsram: At time of definitive surgery
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At time of definitive surgery
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Javier Cortés, MD, Hospital Universitario Vall d´Hebron
- Huvudutredare: Aleix Prat, MD, Vall d´Hebron Institut d´Oncologia
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Prat P, Llombart A, de la Peña L, Di Cosimo S, Oliveira M, Ortega V, Rubio I, Muñoz E, Harbeck N, Cortés J. NeoEribulin: A Phase II, non-randomized, open-label, single-arm, multicenter, exploratory pharmacogenomic study of single agent eribulin as neoadjuvant treatment for operable Stage I-II HER2 non-overexpressing breast cancer. Poster session presented at: 35th Annual San Antonio Breast Cancer Symposium (SABCS); 2012 December 4th-8th; San Antonio, Texas, United States.
Användbara länkar
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 augusti 2012
Primärt slutförande (Faktisk)
1 juni 2015
Avslutad studie (Faktisk)
1 juni 2015
Studieregistreringsdatum
Först inskickad
9 augusti 2012
Först inskickad som uppfyllde QC-kriterierna
16 augusti 2012
Första postat (Uppskatta)
20 augusti 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 november 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
31 oktober 2017
Senast verifierad
1 oktober 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SOLTI-1007
- 2012-000394-23 (EudraCT-nummer)
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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Institut Cancerologie de l'OuestAvslutad
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Memorial Sloan Kettering Cancer CenterSynDevRx, Inc.RekryteringBröstcancer | Metastaserande trippelnegativ bröstcancerFörenta staterna
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Italian Sarcoma GroupEisai Inc.Rekrytering
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Shengjing HospitalHar inte rekryterat ännuTrippel negativ bröstcancerKina
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Oncologia Medica dell'Ospedale FatebenefratelliMario Negri Institute for Pharmacological ResearchAvslutadMetastaserad bröstcancer | Giftighet | Neurotoxicitet | Negativ droghändelse | LäkemedelstoxicitetItalien