Pharmacogenomic Study of Neoadjuvant Eribulin for HER2 Non-overexpressing Breast Cancer

NCT ID: NCT01669252

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-06-30

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Eribulin; Neoadjuvant; PAM50; Triple-negative; Luminal A; Luminal B

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Eribulin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Halaven(R)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: collaborator

SOLTI Breast Cancer Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javier Cortés, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Vall d´Hebron

Aleix Prat, MD

Role: PRINCIPAL_INVESTIGATOR

Vall d´Hebron Institut d´Oncologia

Locations

Institut Gustave Roussy

Villejuif, , France

Brustzentrum im Krankenhaus Köln-Holweide Priv. Doz.

Cologne, , Germany

Klinikum des Landkreises Deggendorf Frauenklinik Mammazentrum

Deggendorf, , Germany

Brustzentrum der Universität München

Munich, , Germany

Klinikum Südstadt Rostock, Universitätsfrauenklinik und Poliklinik

Rostock, , Germany

Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE

Coimbra, , Portugal

Hospital da Luz

Lisbon, , Portugal

Instituto Portugues de Oncologia de Porto Francisco Gentil, EPE

Porto, , Portugal

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitario Vall d´Hebron

Barcelona, , Spain

Hospital Universitario Vall d´Hebron

Barcelona, , Spain

Complejo Hospitalario de Castellón

Castellon, , Spain

Complejo Hospitalario San Pedro de Alcántara

Cáceres, , Spain

Hospital Universitario Reina Sofia

Córdoba, , Spain

Hospital Marina Salud de Denia

Denia, , Spain

Complejo Hospitalario de Jaén

Jaén, , Spain

Hospital Universitari Arnau de Vilanova de Lleida

Lleida, , Spain

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Hospital Universitario Clínico San Carlos

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario Puerta de Hierro de Majadahonda

Madrid, , Spain

Hospital Universitario Virgen de la Arrixaca

Murcia, , Spain

Hospital Universitari Sant Joan de Reus

Reus, , Spain

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, , Spain

Hospital Virgen de la Macarena

Seville, , Spain

Hospital Universitario Virgen del Rocío

Seville, , Spain

Hospital de Torrevieja

Torrevieja, , Spain

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Hospital Arnau de Vilanova de Valencia

Valencia, , Spain

Hospital Universitario Lozano Blesa

Zaragoza, , Spain

Countries

France; Germany; Portugal; Spain

References

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.

Reference Type: BACKGROUND

Related Links

http://www.gruposolti.org

SOLTI Breast Cancer Research Group

Other Identifiers

2012-000394-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SOLTI-1007

Identifier Type: -

Identifier Source: org_study_id