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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2005-001484-64
    Sponsor's Protocol Code Number:IBCSG 27-02/BIG 1-02/GEICAM 2002/04
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-03-23
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-001484-64
    A.3Full title of the trial
    Chemotherapy for Radically Resected Loco-regional Relapse
    A randomized clinical trial of adjuvant chemotherapy for radically resected
    loco-regional relapse of breast cancer
    Chemotherapy vs. Observation
    A.3.2Name or abbreviated title of the trial where available
    Chemotherapy for Radically Resected Loco-regional Relapse
    A.4.1Sponsor's protocol code numberIBCSG 27-02/BIG 1-02/GEICAM 2002/04
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInternational Breast Cancer Study Group (IBCSG)
    B.1.3.4CountrySwitzerland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 with radically treated isolated local and/or regional recurrence of invasive
    breast cancer after mastectomy or breast-conserving surgery.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10006190
    E.1.2Term Breast cancer invasive NOS
    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 the efficacy of adjuvant chemotherapy after radical local treatment of a first loco-regional recurrence of breast cancer.
    Treatment comparisons will be based upon the following endpoints:
    • Disease-free survival (primary end point)
    • Overall survival, systemic relapse and systemic disease-free survival
    E.2.2Secondary objectives of the trial
    Treatment comparisons will also be based upon the following additional endpoints:
    • Sites of first recurrence after randomization to this trial
    • Incidence of second (non-breast) malignancies
    • Causes of deaths without relapse of breast cancer
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histologically verified first local and/or regional (ipsilateral axillary or internal mammary lymph node) recurrence of invasive breast cancer following primary treatment with mastectomy or lumpectomy/quadrantectomy with clear surgical margins. Regional lymph node staging and radiation therapy at primary treatment are not eligibility criteria.
    Local failure is defined as tumor recurrence in any soft tissue of the ipslateral conserved breast or the chest wall, mastectomy scar, and/or skin.
    Regional failure is defined as a tumor recurrence in the ipsilateral axillary lymph nodes, extranodal soft tissue of the ipsilateral axilla, and/or ipsilateral internal mammography. Regional failure does not include supraclavicular lymph nodes or tumor in the opposite breast.

    Surgical resection of the recurrence with uninvolved (“clear”) margins (R0). Planned radiotherapy with ≥40 Gy for patients who had no adjuvant radiation treatment OR
    Mastectomy of the recurrence with uninvolved ('clear') margins (R0) after lumpectomy/quadrantectomy alone for the primary. Radiotherapy is recommended but NOT mandatory OR
    Surgical resection with microscopically involved margins (R1): Patients are eligible only if radiation treatment with ≥40 Gy is planned. The radiation therapy must at least involve the positive resection margin and a safety margin. Localized fields with techniques using an adequate radiation dose ( such as electron beam therapy or brachytherapy) are permitted.

    No evidence of distant metastasis on standard staging examinations (x-ray or CT scan of the chest, ultrasound or CT scan of the abdomen and pelvis, bone scintigraphy) only if alkaline phosphatase is > 2x normal or if medically indicated (e.g. bone pain).

    Measurement of hormone receptors in the recurrent tumor by the locally preferred method (immunohistochemistry and/or ligand binding assay). Each institution should use its own standard for defining endocrine-responsive disease (ER+ and/or PgR+). These standards should be defined prospectively.

    Medically suitable for chemotherapy of 3 to 6 months duration.

    Written informed consent.

    Patients must be informed of, and agree to, data and material transfer and handling, in accordance with national data protection guidelines.

    Patients must be geographically accessible for follow-up.
    E.4Principal exclusion criteria
    Patients with macroscopically incomplete surgery.

    Patients with microscopically involved margins of resection and impossibility (because of prior radiotherapy) to apply ≥40 Gy of local radiation therapy.

    Patients with bilateral malignancy (except in situ carcinoma), or with a suspicious mass in the opposite breast, unless that mass has been proven by biopsy to be benign.

    Evidence of distant metastasis (including ipsilateral supraclavicular lymph nodes).

    Patients who have had a prior recurrence in any site, including local (except the first loco-regional recurrence described under inclusion criteria).

    Patients, who, before randomization, have skeletal pain of unknown cause, elevated alkaline phosphatase, or a bone scan showing hot spots for which metastases cannot be ruled out by X-ray, MRI and/or CT.

    Patients with other primary malignant tumors except adequately treated carcinoma in situ of the uterine cervix and non-melanoma skin cancer.

    Patients with non-malignant systemic diseases that would prevent them from undergoing any of the treatment options, or would prevent prolonged follow-up.

    Patients with psychiatric or addictive disorders that would prevent them from giving informed consent to randomization and therapy.

    Patients with a history of noncompliance to medical regimens and patients who are considered potentially unreliable.
    E.5 End points
    E.5.1Primary end point(s)
    First confirmation of recurrence (local, regional or distant), second primary (including non-breast) tumor, and/or death.

    Disease-free survival (DFS) is defined as the time from randomization to local, regional or distant recurrence (including recurrence restricted to the breast after breast conserving treatment), appearance of a second primary tumor, beginning of a new cancer-specific therapy, or death from any cause, whichever occurs first. An in situ recurrence either in the ipsilateral or in the contralateral breast is not considered a recurrence.
    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 Yes
    E.6.4Safety No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No adjuvant chemotherapy (observation)
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    After maximal treatment duration of 32 weeks, follow-up will take place every 3 months during years 1-2, every six months years 3-5 and yearly thereafter lifelong.

    The target number of events for the study is 124, and the interim analysis will be planned after 70 events have been observed.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-03-23. Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 265
    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 Decision2006-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-08-22
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue May 07 00:45:54 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA