Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35898   clinical trials with a EudraCT protocol, of which   5892   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-005328-17
    Sponsor's Protocol Code Number:MO28048
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-02-27
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2011-005328-17
    A.3Full title of the trial
    A phase III prospective, two-cohort non-randomized, multi-centre, multinational, open label study to assess the safety of assisted- and self-administered subcutaneous trastuzumab as therapy in patients with operable Her2-positive early breast cancer [SafeHer study]
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the safety of assisted- and self-administered subcutaneous trastuzumab as therapy in patients with operable Her2-positive early breast cancer
    A.3.2Name or abbreviated title of the trial where available
    SafeHer Study
    A.4.1Sponsor's protocol code numberMO28048
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF.Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41616881111
    B.5.5Fax number+41616919319
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 No
    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 for SC injection
    D.3.2Product code Ro 045-2317/F07
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRASTUZUMAB SC
    D.3.9.1CAS number 180288-69-1
    D.3.9.2Current sponsor codeRO0452317
    D.3.9.3Other descriptive namerhuMAb HER2, Anti-HER
    D.3.9.4EV Substance CodeSUB12612MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 Yes
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 No
    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 SC
    D.3.2Product code Ro 045-2317/F06
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRASTUZUMAB SC
    D.3.9.1CAS number 180288-69-1
    D.3.9.2Current sponsor codeRO0452317
    D.3.9.3Other descriptive namerhuMAb HER2, Anti-HER
    D.3.9.4EV Substance CodeSUB12612MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 Yes
    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-positive primary breast cancer
    E.1.1.1Medical condition in easily understood language
    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 16.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 assess the overall safety and tolerability of subcutaneous (SC) trastuzumab in HER2-positive early breast cancer (EBC) patients with assisted administration using a conventional syringe and needle (vial formulation) and with assisted administration with or without self-administration using a single-use injection device (SID).
    E.2.2Secondary objectives of the trial
    • Efficacy (both cohorts):
    - disease-free survival (DFS)
    - overall survival (OS)
    • Patient satisfaction with trastuzumab SC administration using the SID (patients in Cohort B who went on to self-administration of the study drug).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    In some countries and sites, Medical Care Utilization (MCU, e.g. Time and Motion) and/or pharmacoeconomic sub-studies will be conducted.
    E.3Principal inclusion criteria
    1. Signed written informed consent approved by the reviewing independent Ethics Committee
    2. Female or male aged 18 years or above
    3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
    4. Histologically confirmed early invasive HER2-positive carcinoma of the breast with no evidence of residual, locally recurrent or metastatic disease and defined as clinical stage I (T1, N0, M0) to IIIC (any T, N3, M0) that is eligible for treatment with trastuzumab.
    Note: Patients treated without neoadjuvant or adjuvant chemotherapy, such as patients with low risk node negative tumours ≤ 1.0 cm, elderly patients (>65 years of age) or patients with HER2-positive EBC but denying chemotherapy, will also be eligible to participate in the study, but their enrolment will be limited to approximately 10% of the total study population.
    5. HER2-positive EBC, defined as IHC 3+, or a positive in situ hybridization (ISH testing) by validate and approved methods within a certified laboratory.
    6. Screening left ventricular ejection fraction (LVEF) ≥ 55% as measured by echocardiography, Multi Gated Acquisition (MUGA) scan or Magnetic Resonance Imaging (MRI) per local practice.
    7. Agreement to use an adequate, non-hormonal means of contraception by women of childbearing potential (defined as pre-menopausal and not surgically sterilized or < 1 year after the onset of menopause) and by male participants with partners of childbearing potential only. Examples of adequate contraceptive measures are an intra-uterine device, a barrier method (condoms, diaphragm) in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not acceptable for females participating in the study.
    8. Intact skin at site of SC injection on the thigh.
    E.4Principal exclusion criteria
    Cancer Related Criteria
    1. Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent
    2. History of other malignancy which could affect compliance with the protocol or interpretation of results (including previous invasive ipsilateral or contralateral breast cancer). Patients with curatively treated carcinoma in situ of the cervix or basal cell carcinoma, and patients with other curatively-treated malignancies, other than breast cancer, who have been disease-free for at least 5 years, are eligible.
    3. Past history of ductal carcinoma in situ (DCIS) within the last 5 years that has been treated with any systemic therapy OR with radiation therapy to the ipsilateral breast where invasive cancer subsequently develops. Patients who had their DCIS treated with surgery only are allowed to enter the study.
    4. Metastatic disease
    Haematological, Biochemical and Organ Function Related Criteria
    5. Inadequate bone marrow function (as indicated by any of the following):
    • Total white blood cell count < 2,500 / mm3 (<2.5 x 10e9/L)
    • Neutrophil count < 1,500 / mm3 (< 1.5 x 10e9/L)
    • Platelets < 100,000 / mm3 (< 100 x 10e9/L)
    • Haemoglobin < 10 g/dL
    6. Impaired hepatic function (as indicated by any of the following):
    • Serum total bilirubin > 1.5 x upper limit of normal (ULN)
    • Alanine amino transferase > 2.5 x ULN
    • Aspartate amino transferase > 2.5 x ULN
    • Alkaline phosphatase > 2.5 x ULN
    7. Impaired renal function: serum creatinine > 1.5 x ULN
    Other Study Drug Related Exclusion Criteria
    8. Serious cardiac illness or medical conditions including but not confined to:
    • History of documented heart failure or systolic dysfunction (LVEF < 50%)
    • High-risk uncontrolled arrhythmias such as atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade atrioventricular (AV) block (second degree AV-block Type 2 [Mobitz 2] or third degree AV-block)
    • Angina pectoris requiring anti-anginal medication
    • Clinically significant valvular heart disease
    • Evidence of transmural infarction on electrocardiogram (ECG)
    • Poorly controlled or uncontrolled hypertension (blood pressure consistently over 140/90 mmHg, despite treatment), or history of hypertensive crisis or hypertensive encephalopathy
    9. Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness
    10. Prior maximum cumulative dose of doxorubicin >360 mg/m2 or maximum cumulative dose of epirubicin >720 mg/m2 or equivalent
    11. Known hypersensitivity to trastuzumab, murine proteins, or a general hypersensitivity to adhesives (Cohort B only)
    12. History of severe allergic or immunological reactions, e.g. difficult to control asthma
    General Exclusion Criteria
    13. Pregnancy or lactation
    14. Unable or unwilling to comply with the requirements of the protocol as assessed by the investigator
    15. Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
    16. Major surgical procedure or significant traumatic injury within 14 days prior to the first dose of study treatment or anticipated need for major surgery during the course of study treatment except for breast cancer surgery for patient receiving study drug in the neoadjuvant setting. Patients must be free of any clinically significant sequalae of prior surgery before they can receive their first dose of study treatment.
    17. More than 12 weeks between the end of the last chemotherapy cycle and the first dose of study treatment, in case these treatments are initiated sequentially. This criterion does not apply to patients who are starting trastuzumab SC without previous or concurrent chemotherapy or concurrently with chemotherapy.
    18. Current peripheral neuropathy of grade 3 or greater per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints are the primary objectives in this study and will include: all AEs, Grade ≥3 AEs, SAEs, AEs leading to premature discontinuation of study treatment, AEs causing interruption of trastuzumab SC, cardiac AEs, CHF-related SAEs, premature withdrawals from study and study medication, exposure to treatment, laboratory parameters, LVEF, vital signs, ECG, weight, and ECOG performance status.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis of the safety endpoints will take place when all patients have received 18 cycles of trastuzumab SC and have completed the Safety Follow-up assessments (4 weeks after their last dose of study treatment).
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints include DFS, OS (both cohorts) and patients’ satisfaction with trastuzumab SC administration using the SID (Cohort B patients who went on to self administration only).
    E.5.2.1Timepoint(s) of evaluation of this end point
    A preliminary analysis of DFS and OS will be undertaken at the time of the primary safety analysis, i.e. when all patients have received 18 cycles of trastuzumab SC and have completed the Safety Follow-up assessments (4 weeks after their last dose of study treatment). The final analysis of OS and DFS will take place when the last patient has been followed up for approximately 5 years after her/his last study treatment, or earlier, if one of the following is documented for all treated patients: withdrawal of consent, loss to follow-up or 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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, Patient satisfaction and Medical Care Utilization
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA337
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Albania
    Algeria
    Argentina
    Australia
    Bosnia and Herzegovina
    Brazil
    Canada
    Chile
    Colombia
    Croatia
    Dominican Republic
    Ecuador
    Egypt
    El Salvador
    European Union
    Guatemala
    Hong Kong
    India
    Indonesia
    Korea, Republic of
    Malaysia
    Mexico
    Morocco
    New Zealand
    Pakistan
    Panama
    Peru
    Philippines
    Russian Federation
    Saudi Arabia
    Serbia
    Singapore
    South Africa
    Switzerland
    Taiwan
    Thailand
    Turkey
    Ukraine
    United Arab Emirates
    Venezuela, Bolivarian Republic of
    Vietnam
    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 is defined as the last patient last visit in the follow-up period. The study will end when all patients have been followed for at least 5 years after their last study treatment, or earlier, if one of the following is documented for all treated patients: withdrawal from the study, loss to follow up or death.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    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 years8
    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: 2200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1447
    F.4.2.2In the whole clinical trial 2500
    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)
    Patients who discontinue study treatment prematurely due to lack of tolerability will be clinically managed as per local practice and followed as outlined in the Schedule of Assessments, Appendix 1.
    All prematurely withdrawn patients, who have received at least one dose of trastuzumab, should continue to be monitored for cardiac function as described in the Herceptin SmPC, within or outside the study, as appropriate.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-03
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA