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    Summary
    EudraCT Number:2012-000394-23
    Sponsor's Protocol Code Number:SOLTI-1007
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-30
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2012-000394-23
    A.3Full title of the trial
    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
    Offene, einarmige, pharmakogenomische explorative Phase-II-Studie zum Einsatz von Eribulin (HALAVEN®) als Einzelwirkstoff bei der neoadjuvanten Therapie von operablem Stadium I-II-Brustkrebs ohne HER2-Überexpression.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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
    Offene, einarmige, pharmakogenomische explorative Phase-II-Studie zum Einsatz von Eribulin (HALAVEN®) als Einzelwirkstoff bei der neoadjuvanten Therapie von operablem Stadium I-II-Brustkrebs ohne HER2-Überexpression.
    A.3.2Name or abbreviated title of the trial where available
    SOLTI NEOERIBULIN
    A.4.1Sponsor's protocol code numberSOLTI-1007
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSOLTI
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEISAI
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTrial Form Support, S.L.
    B.5.2Functional name of contact pointFernando García de Blas
    B.5.3 Address:
    B.5.3.1Street AddressCalle Arturo Soria, 336. 7ª planta Izq.
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number3491125 05 50
    B.5.5Fax number3491125 05 51
    B.5.6E-mailfernando.garcia@tfscro.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name HALAVEN®
    D.2.1.1.2Name of the Marketing Authorisation holderEisai Europe Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNot Applicable
    D.3.2Product code Not Applicable
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEribulin
    D.3.9.1CAS number 253128-41-5
    D.3.9.2Current sponsor codeEribulin
    D.3.9.3Other descriptive nameEribulin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.23
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients at Stage I-II HER2-negative breast cancer
    E.1.1.1Medical condition in easily understood language
    Patients at Stage I-II HER2-negative breast cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Analyze pre-treatment expression of mRNA from breast tumors in order to identify potential predictors of response - defined as pathological complete response in the breast (pCRb)- to eribulin administered in the neoadjuvant setting.
    E.2.2Secondary objectives of the trial
    Asses the rate of pCRb and pCR in the breast and axillary lymph nodes (pCRbl) as definitive surgery after neoadjuvant treatment with eribulin.
    Determinate the clinical and radiological overall response rate (ORR).
    To determinate the biological activity of the treatmnent with eribulin, assessed by comparing gene expression at different time points and their correlation pCRb rate.
    To estimaste the sensitivity and specifity of gene expression at the different time points to predict clinical response to eribulin administered in the neoadjuvant setting.
    To determinate the correlation of pCRb with breast cancer subtype (Luminal A, Luminal B, Basal-like, HER2-enriched and Claudin-low.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written IC must be given according to ICH/GCP guidelines and national/local regulations before patient registration, specifically highlighting the generation of molecular characterization of tumor and genomic samples.
    2. Age ≥18 years.
    3. Histologically confirmed invasive breast carcinoma with all of the following characteristics:
    a. Primary tumor ≥2 cm in largest diameter (cT1-3) assessed by physical examination and mammography and/or breast US and/or breast MRI (where available). If the tumor is not palpable or measures less than 2 cm in physical examination, the patient is eligible if the imaging technique (mammography and/or breast US and/or breast MRI) shows a tumor of at least 2 cm.
    b. cN0-1: patients with clinically evident axillary lymph nodes can be included, but not if metastasis in ipsilateral level I/II axillary lymph nodes are fixed to one another (matted) or to other structures (N2a). Patients with clinically involved internal mammary or supraclavicular nodes (i.e., cN2b-3) are also excluded.
    c. No evidence of distant metastasis (M0).
    4. BC must be eligible for definitive primary surgery.
    5. Available pre-treatment core (Tru-cut) biopsy or possibility of performing one.
    6. HER2- BC (as per local assessment), defined by any of the following:
    a. 0-1+ expression by IHC.
    b. 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).
    c. Is situ hybridization (FISH/CISH) without HER2 gene amplification, independently of IHC.
    7. Known hormone receptor (ER/PgR) status (as per local assessment) or possibility of performing the tests.
    8. Known percentage of hormone receptor (ER/PgR) and Ki67-positive tumor cells (as per local assessment), or possibility of performing the tests.
    9. Multifocal tumors (defined as the presence of two or more foci of cancer within the same breast quadrant) are allowed. However, if a multifocal tumor is present:
    a. The largest lesion must be ≥2 cm. It will be considered as the target lesion for all subsequent tumor evaluations.
    b. HER2- status must be documented in all the tumor foci.
    c. ER/PgR status of the target lesion will be considered to classify the BC subtype, as determined by IHC criteria.
    10. ECOG performance status of 0 or 1 (see Appendix B for definitions).
    11. Adequate laboratory values as follows:
    a. Absolute neutrophil count (ANC) ≥1.5 x 109/L.
    b. Platelets count ≥100 x 109/L.
    c. Hemoglobin ≥9 g/dL.
    d. Serum bilirubin ≤1.5 time the upper limit of normal (ULN). In the case of known Gilbert’s syndrome, a higher serum total bilirubin (<2 x ULN) is allowed.
    e. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x ULN.
    f. Alkaline phosphatase (AP) ≤2.5 x ULN.
    g. Serum creatinine ≤1.5 mg/dL or calculated creatinine clearance ≥60 mL/m.
    12. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
    13. Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol; those conditions should be discussed with the patient before registration in the trial.
    E.4Principal exclusion criteria
    1. Any prior treatment for primary invasive BC.
    2. Metastatic, locally advanced, or inflammatory BC (i.e., Stage III or IV BC).
    3. Bilateral invasive BC.
    4. Multicentric BC, defined as the presence of two or more foci of cancer in different quadrants of the same breast.
    5. Pre-existing peripheral neuropathy of any grade.
    6. Uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100mmHg).
    7. Clinically significant (i.e., active) cardiovascular disease, including cerebrovascular accident (≤6 months before enrolment), myocardial infarction (≤6 months before enrolment), unstable angina, New York Heart Association ≥ grade 2 congestive heart failure, serious cardiac arrhythmia requiring medication during the study and that might interfere with regularity of the study treatment, or not controlled by medication.
    8. Long QT syndrome.
    9. Concomitant use of inhibitors of hepatic transport proteins, such as organic anion-transporting proteins (OATPs), P-glycoprotein (Pgp), multidrug resistant proteins (MRPs), etc. Inhibitors of such transporters include but are not limited to: cyclosporine, ritonavir, saquinavir, lopinavir, and certain other protease inhibitors, efavirenz, emtricitabine, verapamil, clarithromycin, quinine, quinidine and disopyramide.
    10. Major medical conditions that might affect study participation (e.g., active peptic ulcer disease, uncontrolled diabetes mellitus, uncontrolled seizure disorder, uncontrolled pulmonary, renal or hepatic dysfunction, or uncontrolled infection).
    11. 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.
    12. Known human immunodeficiency virus (HIV) infection or other active or serious infection requiring IV antibiotics at enrollment.
    13. Pregnancy or breastfeeding women.
    14. Women of childbearing potential (<2 years after the last menstruation) not using effective, non-hormonal means of contraception (e.g., intra-uterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly, or surgically sterilized) during the study and for a period of 6 months following the last administration of study drug.
    15. Administration of any live virus vaccine within 8 weeks preceding study entry.
    16. Use of any investigational agent within 30 days of administration of the first dose of study drug or concurrent treatment on another clinical study.
    17. Requirement for radiation therapy concurrent with study anticancer treatment. Patients who require breast or chest wall radiation therapy after surgery are eligible.
    18. Known hypersensitivity to the study drug or excipients.
    19. Inability or unwillingness to abide by the study protocol or cooperate fully with the Investigator or designee.
    E.5 End points
    E.5.1Primary end point(s)
    Correlation of pre-treatment expression of mRNA from primary breast tumors with pCRB after neoadjuvant treatment with eribulin.
    E.5.1.1Timepoint(s) of evaluation of this end point
    LSLV
    E.5.2Secondary end point(s)
    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.
    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.
    Clinical and radiological ORR, defined by RECIST 1.1 as complete response (CR) plus partial response (PR). Physical examination and breast mammography and/or breast US and/or breast MRI will be used to evaluate clinical and radiological response.
    Analysis of the expression of mRNA from breast tumors at the initial biopsy, after 21 days of treatment (Cycle 2 Day 1) with eribulin and at surgery (if pCRB is not achieved).
    Correlation of mRNA expression in breast tumors after 21 days of neoadjuvant treatment with eribulin and at surgery (if pCRB is not achieved) with pCRB.
    Correlation of mRNA expression in breast tumors with clinical and radiological ORR at different time points during the neoadjuvant treatment with eribulin.
    Sensitivity and specificity of gene expression at the initial biopsy, after 21 days of treatment with eribulin and at surgery to predict clinical response to eribulin administered in the neoadjuvant setting.
    Rate of pCRB according to breast cancer subtype: Luminal A, Luminal B, Basal-like, HER2-enriched and Claudin-low.
    Rate of pCRB according to breast cancer subtype determined by immunohistochemistry (following the 2011 St. Gallen definitions): Luminal A, Luminal B, and TNBC.
    Proportion of patients able to have breast conservation surgery after being treated with eribulin as neoadjuvant therapy.
    Safety and AEs (assessed by CTCAE v.4), including the following parameters: -General safety, assessed by monitoring all AEs and serious AEs, laboratory measurements, vital signs, and physical exams -Percentage of patients with neutropenia Grade 3-4 -Percentage of subjects with neuropathy -Incidence of fatigue -Dose reductions and dose delays due to treatment toxicity
    The correlation between alternations in tubulin isotype expression and mutational status in pre-treatment samples with efficacy parameters, such as pCRB, ORR and BOR.
    The correlation between exome or genome sequencing data from pre-treatment samples with pCRB after neoadjuvant treatment with eribulin.
    Changes in gene expression and gene mutational status between the pre-treatment samples and samples after treatment (if tumor tissue remains).</
    E.5.2.1Timepoint(s) of evaluation of this end point
    LSLV
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After surgery, anthracycline-based adjuvant chemotherapy (e.g., FAC, FEC, AC, or EC), adjuvant radiotherapy, and adjuvant hormonal therapy (if ER/PgR+ tumors) are recommended. However, the type of adjuvant treatment will be as per investigator´s choice and local standards of care.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-10-21
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