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    Summary
    EudraCT Number:2006-002860-25
    Sponsor's Protocol Code Number:ML19944
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-06-14
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2006-002860-25
    A.3Full title of the trial
    A multicenter randomized phase II trial to compare trastuzumab (Herceptin®) continuation or discontinuation in combination with 2nd-line chemotherapies after progression on a 1st-line chemotherapy combined with trastuzumab in patients with HER2 positive metastatic breast cancer (Treatment Beyond Progression, TBP)
    A.3.2Name or abbreviated title of the trial where available
    PANDORA
    A.4.1Sponsor's protocol code numberML19944
    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 SponsorRoche Hungary Ltd.
    B.1.3.4CountryHungary
    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 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 Yes
    D.2.1.1.1Trade name Herceptin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited, UK
    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.3.2Product code Ro-45-2317
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.2Current sponsor codeRO-452317
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number150
    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) 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
    Metastacic breast cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    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 time to disease progression (TTP) in HER2 positive metastatic breast cancer patients treated with trastuzumab in combination with 2nd-line chemotherapy following progression after 1st-line chemotherapy plus trastuzumab treatment.
    E.2.2Secondary objectives of the trial
    To evaluate the following in HER2 positive metastatic breast cancer patients treated with trastuzumab in combination with 2nd-line chemotherapy following progression after 1st-line chemotherapy plus trastuzumab treatment:
    • Objective response rate (ORR)
    • Clinical benefit rate (CR + PR + SD)
    • Time to treatment failure (TTF)
    • Safety
    • Overall survival (OS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written and signed informed consent prior to beginning specific protocol procedures showing the patients’ willingness and awareness to participate in the trial and comply with its proceedings.
    2. Female patients
    3. Age ≥18 years.
    4. Pathologically confirmed and documented metastatic breast cancer.
    5. Documented HER2-overexpression of the primary or metastatic tumor tissue detected by immunohistochemistry (IHC 3+) and/or genamplification detected by FISH or CISH.
    6. Adjuvant treatment with trastuzumab and/or anthracyclines is allowed.
    7. Disease progression during or after a previous 1st-line chemotherapy* plus trastuzumab** treatment as follows:
    • Either of taxanes (docetaxel or paclitaxel) and trastuzumab given as 1st-line therapy for palliation
    • Other allowed chemotherapy drugs combined with trastuzumab in 1st-line setting: vinorelbine, gemcitabine, capecitabine, platinum compounds, cyclophosphamide, methotrexate, fluorouracil.
    • Trastuzumab may have been given as monotherapy in the first-line setting if the allowed first-line chemotherapy was discontinued earlier.
    8. Patients are scheduled to receive an effective 2nd-line chemotherapy as per standard medication care. Schedule and dose as investigators’ opinion in the best interest of the patients. List of the allowed drugs for the 2nd-line chemotherapy are detailed in Appendix 1.
    9. Treatment free interval of trastuzumab between 1st-line and 2nd-line administration is a maximum of 6 weeks.
    10. At least 4 weeks since major surgery with full recovery.
    11. At least 4 weeks since radiotherapy with full recovery.
    12. Complete radiology and tumor measurement work up within 3 weeks prior to randomization.
    13. Laboratory: neutrophils count ≥ 1,5 x 109/L, platelet ≥ 100 x 109/L, bilirubin <=2 x the upper limit of normal for the institution (ULN), SGOT/SGPT <= 2,5 x ULN or < 5 x ULN for patients with liver metastases, creatinine <=2.0 mg/dl (within 3 weeks prior to randomization).
    14. Left ventricular ejection fraction (LVEF) by cardiac ultrasound or MUGA of >= 50% within 3 weeks prior to randomization.
    15. If of childbearing potential, pregnancy test – either urine or serum test - is negative within 1 week prior to randomization. In addition the patient agrees to use an effective, but other than hormonal method to avoid pregnancy during the study.
    16. ECOG performance status <= 2 and life expectancy >=12 weeks (see Appendix 2)
    17. Patients must be accessible for treatment and follow-up.
    18. Patients entering the trial must be treated and followed at the participating center.
    * Ad 1st-line therapy: Schedule and dose as investigators’ opinion in the best interest of the patients. Trastuzumab in combination with either of taxanes is considered as standard 1st-line therapy. Anthracyclines are not allowed in this setting.
    ** Trastuzumab had to be given for at least 12 weeks in first line setting.
    E.4Principal exclusion criteria
    1. Known hypersensitivity reaction to the compounds or incorporated substances.
    2. Concurrent immunotherapy or hormonal therapy (antihormonal, contraceptive or replacement therapy) is not allowed at study entry.
    3. Anthracyclines in combination with trastuzumab as a part of 1st-line treatment or planned anthracycline administration as 2nd-line chemotherapy.
    4. Known anamnestic history (or present condition) of brain metastases (including parenchymal and leptomeningeal metastases).
    5. Prior history of myocardial infarction within the previous 6 months.
    6. Unstable angina pectoris, uncontrolled arrhythmia and cardiac insufficiency (NYHA Class III-IV) at the time of inclusion.
    7. Cardiac toxicity during the previous 1st-line treatment indicating discontinuation of Herceptin® administration.
    8. Serious rest dyspnoe in connection with the advanced malignant process claiming supportive oxygen therapy.
    9. Clinically significant pleural effusion.
    10. Serious intercurrent medical conditions that may interfere with the planned treatment (including AIDS, serious active infection, CNS disease, psychiatric illness).
    11. History of invasive malignancy (including second primary breast cancer) other than metastatic breast cancer within the last five years which could affect compliance with the protocol or interpretation of results, except for curatively treated:
    - basal and squamous cell carcinoma of the skin.
    - in situ carcinoma of the cervix.
    12. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
    13. Pregnant or nursing women.
    14. Patients who in opinion of investigator are ineligible for 2nd-line chemotherapy.
    E.5 End points
    E.5.1Primary end point(s)
    Time to Disease progression
    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 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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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 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
    Patients with progression or withdrawal will be followed (adverse events and survival) up to one year following from the date the last patient is enrolled.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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) Yes
    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 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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 94
    F.4.2.2In the whole clinical trial 114
    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)
    NA
    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 Decision2008-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-24
    P. End of Trial
    P.End of Trial StatusCompleted
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