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    Summary
    EudraCT Number:2009-017485-23
    Sponsor's Protocol Code Number:EORTC90091-10093
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-04-22
    Trial results View 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 ConcernedFrance - ANSM
    A.2EudraCT number2009-017485-23
    A.3Full title of the trial
    TRastuzumab in HER2-negative Early breast cancer as Adjuvant Treatment for Circulating Tumor Cells (CTC) ("Treat CTC" trial)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trastuzuamb in HER-2 negative early breast cancer as added treatment after surgery for patients presenting CTC (Circulating Tumor Cells)
    A.4.1Sponsor's protocol code numberEORTC90091-10093
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01548677
    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 SponsorEORTC
    B.1.3.4CountryBelgium
    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 supportRoche
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEORTC
    B.5.2Functional name of contact pointAmira AbdelAlim
    B.5.3 Address:
    B.5.3.1Street AddressAv Emanuel Mounier 83/11
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3227741023
    B.5.5Fax number+3227741030
    B.5.6E-mailregulatory@eortc.be
    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 Herceptin vials 150mg
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameHerceptin
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    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 INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.9.4EV Substance CodeSUB12612MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) Yes
    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
    HER2-Negative Early Breast Cancer
    E.1.1.1Medical condition in easily understood language
    High Risk Early Breast Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate whether trastuzumab decreases the detection rate of CTC in patients with HER2-negative primary BC by comparing the trastuzumab treated arm to the observation arm.
    E.2.2Secondary objectives of the trial
    ♦ To evaluate in a clinical trial setting the feasibility, reliability, within patient reproducibility and variability of the assay for CTC
    ♦ To compare clinical outcomes (as measured by Recurrence Free Interval (RFI), Invasive Disease Free Survival (IDFS), Disease Free Survival (DFS) and Overall Survival (OS)) between the trastuzumab and observation arms
    ♦ To assess safety, especially cardiac safety, of trastuzumab in women with HER2-negative primary tumors
    ♦ To correlate CTC detection rate at baseline and/or week 18 with RFI, IDFS, DFS, OS
    ♦ To collect biological material in order to perform translational research
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    -Translational Research
    -Detection of HER2-positive CTC and response to trastuzumab.
    -Primary tumor DNA mutational and mRNA profiles and response to trastuzumab.
    -Plasma circulating nucleic acids / proteomics or other biomarkers and response to trastuzumab
    E.3Principal inclusion criteria
    ♦ Female gender
    ♦ Age ≥ 18 years
    ♦ Written informed consent must be given according to ICH/GCP, and national/local regulations
    ♦ Availability of peripheral blood draw for CTC blood test
    ♦ Tumor block or minimum 10 unstained slides of 10 μm of primary tumor must be available prior to registration for centralized HER2 testing
    ♦ ER status available
    ♦ Adequately excised non-metastatic and non-relapsed operable primary invasive HER2-negative adeno-carcinoma of the breast that is all of the following*:
    ♦ Histological Grade > 1 at time of surgery and primary tumor size > 1 cm
    ♦ the patient should have completed either
    ♦ adjuvant chemotherapy for node-positive disease (pN ≥1, macrometastasis only) or
    ♦ neoadjuvant chemotherapy; in this case residual invasive disease in breast or lymph nodes is required (no complete pathological response)
    ♦ Completion of (neo-) adjuvant chemotherapy and no further adjuvant chemotherapy treatment planned. Prior chemotherapy with doxorubicin restricted to a total dose of 360 mg/m2 or with epirubicin restricted to a total dose of 720 mg/m2 is allowed
    ♦ No prior use of anti-HER2 therapy for any reason or other prior use of biological agent or immunotherapy for BC
    ♦ No prior and or concomitant use of bisphosphonate therapy for any reason
    ♦ No prior mediastinal irradiation except internal mammary node irradiation for the present BC
    ♦ Concomitant adjuvant hormonal therapy or radiotherapy (if applicable) is allowed upon physician’s choice
    ♦ The interval between definitive surgery (neoadjuvant population) or end of adjuvant chemotherapy (adjuvant population) and registration must be at least 3 weeks but no more than 12 weeks
    ♦ No evidence of unresolved or unstable toxicity from prior surgery, adjuvant chemotherapy or radiotherapy
    ♦ No history of prior (ipsilateral and/or contralateral) invasive breast carcinoma or ductal carcinoma in situ, except for the BC proposed in this study. Bilateral breast cancer is acceptable if both tumors are HER2- negative and have been diagnosed within 2 years from registration
    ♦ No history of any malignant neoplasms in the past 5 years except for curatively treated basal and squamous cell carcinoma of the skin
    ♦ No prior autologous or allogeneic stem cell transplantation
    ♦ No history of serious cardiac illness or medical conditions, including but not confined to:
    ♦ History of documented congestive heart failure
    ♦ High risk uncontrolled arrhythmias
    ♦ Angina pectoris requiring anti-anginal medication
    ♦ Clinically significant valvular heart disease
    ♦ Evidence of transmural infarction on ECG
    ♦ Poorly controlled hypertension (e.g. systolic > 180 mm Hg or diastolic > 100 mm Hg)
    ♦ No history of other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions
    ♦ Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration
    ♦ No concurrent participation in another trial
    * Imaging work up is not mandatory to enter the trial. If there are signs/symptoms suggesting the presence of local relapse or distant metastasis, an appropriate work up should be performed according to the treating physician standard practice. If a patient is confirmed to have local relapse or distant metastasis she is no longer eligible for the trial.
    E.4Principal exclusion criteria
    Please see inclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    Difference in detection rate of CTC at week 18 between trastuzumab and observation
    E.5.1.1Timepoint(s) of evaluation of this end point
    -Criteria for CTC detection
    The following apply at each time point (baseline and week 18) to decide on positive versus negative CTC Blood Tests, as well as to evaluate detection.
    ♦ CTC Blood Test: A blood test (2 x 7.5 mL) for the detection of peripheral blood nucleated cell lacking CD45, expressing cytokeratin 8,18,19
    ♦ Evaluable CTC Blood Test (see chapter 10.3.1
    ♦ CTC Blood Test positive: ≥ 1 CTC / 15 mL of peripheral blood analyzed
    ♦ CTC Blood Test negative: No CTC / 15 mL of peripheral blood analyzed
    ♦ The positive CTC Blood Test will be centrally reviewed based on images. Images will be sent to central lab.
    E.5.2Secondary end point(s)
    ♦ Recurrence Free Interval (RFI)
    ♦ Invasive Disease Free Survival (IDFS)
    ♦ Disease Free Survival (DFS)
    ♦ Overall Survival (OS)
    ♦ Safety, especially cardiac safety (as reported in Appendix C NYHA), as graded by NCI-CTCAE v 4.0 grading.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Recurrence Free Interval: calculated as the time between randomization and recurrence of disease, including any invasive ipsilateral breast tumor, local/regional invasive relapse, distant recurrence, and death from breast cancer documented with an imaging study or biopsy (Hudis et al., Ref. 58).
    -Invasive Disease Free Survival: calculated as the time between randomization and the occurrence of an invasive disease recurrence or death.
    -Disease Free Survival: determined as the time from randomization to either the date of disease progression or the date of death.
    -Overall Survival: calculated as the time from randomization to the date of death.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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 Yes
    E.8.1.2Open Yes
    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.8.3 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 concerned21
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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 No
    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
    End of study occurs when all of the following criteria have been satisfied:
    1. Thirty days after all patients have stopped protocol treatment
    2. At least 2 years after the last patient was randomized ensuring that 50% of patients have achieved 3 years of follow-up (Section 8.1.1).
    3. The database has been fully cleaned and frozen for this secondary analysis
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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: 174
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 174
    F.4.2.2In the whole clinical trial 174
    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)
    As per standard clinical practice at the discretion of the treating physician
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Unicancer
    G.4.3.4Network Country France
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation KLINIKUM DER UNIVERSITÄT MÜNCHEN
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-22
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