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    Summary
    EudraCT Number:2014-004358-32
    Sponsor's Protocol Code Number:IJB–TNBC–1–RHEA
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-03-19
    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 number2014-004358-32
    A.3Full title of the trial
    Biomarker Research Study for PF-03084014 in cHEmoresistant triple negative breast cAncer - “RHEA” study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Biomarker Research Study for PF-03084014 in cHEmoresistant triple negative breast cAncer - “RHEA” study
    A.3.2Name or abbreviated title of the trial where available
    RHEA
    A.4.1Sponsor's protocol code numberIJB–TNBC–1–RHEA
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02338531
    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 SponsorInstitut Jules Bordet
    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 supportPFIZER NV/SA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut Jules Bordet
    B.5.2Functional name of contact pointBrEAST data center
    B.5.3 Address:
    B.5.3.1Street Address7eme etage - boulevard de waterloo 121
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1000
    B.5.3.4CountryBelgium
    B.5.4Telephone number322741 35 09
    B.5.6E-mailrhea.trial@bordet.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 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 namePF-03084014
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNthere is neither a INN nor a proposed INN
    D.3.9.2Current sponsor codePF-03084014_IJB
    D.3.9.3Other descriptive namePF-03084014
    D.3.9.4EV Substance CodeSUB174002
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 with chemoresistant, triple-negative breast cancer
    E.1.1.1Medical condition in easily understood language
    patients with chemoresistant, triple-negative 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 17.1
    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 demonstrate that a 9-day administration of oral PF-03084014 is able to modulate the Notch pathway by down-regulating the expression of the tumor HES4 gene in chemoresistant TNBC (evaluable population for the primary objective).
    E.2.2Secondary objectives of the trial
    1. To determine if a short administration of oral PF-03084014 is safe in patients with chemoresistant TNBC ( safety population)
    2. To assess changes in the tumor transcriptome before and after short administration of oral PF-03084014 (evaluable population for the secondary objective of transcriptome analysis )
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥18 years old.
    2. Female.
    3. Histological diagnosis of breast adenocarcinoma that is estrogen receptor-negative, progesterone receptor-negative and HER2-negative as per the updated American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) guidelines (1) (triple negative).
    Patients with inflammatory breast cancer are eligible.
    Patients with synchronous bilateral cancer and unilateral multifocal or multicentric disease will be allowed to enter the study as long as:
    • Histologic diagnosis of triple-negative breast adenocarcinoma is found in both breast tumor biopsies in case of synchronous bilateral disease.
    • Histologic diagnosis of triple-negative breast adenocarcinoma can be found in all tumor foci biopsies either in same or different breast quadrants in the case of multifocal and multicentric disease, respectively. Biopsy of all tumor foci at diagnosis is not required for study eligibility.

    4. No clinical or radiologic evidence of distant metastasis.

    5. Residual tumor breast adenocarcinoma of at least 1.5 cm (largest focus for bilateral, multifocal or multicentric disease) as assessed by breast magnetic resonance imaging (MRI) or ultrasound (US), performed within 14 days prior to or on the day of the neoadjuvant chemotherapy administration.
    6. Completion of standard anthracycline and taxane-based neoadjuvant chemotherapy. The use of platinum agents in combination with standard neoadjuvant chemotherapy is allowed. The screening schedule is based on the last chemotherapy regimen, and is as follows:
    • for patients receiving taxanes every 3 weeks or taxanes in combination with a platinum agent: the screening period is at least 21 days but no later than 27 days after the day of last chemotherapy administration;
    • for patients receiving weekly taxanes: the screening period is at least 7 days but no later than 13 days after the day of last chemotherapy administration.

    7. ECOG Performance Status (PS) 0 or 1 assessed within 6 days of first PF-03084014 administration.
    8. Adequate Bone Marrow Function to be assessed within 6 days of first PF-03084014 administration, including:
    a. Absolute Neutrophil Count (ANC) ≥1500/μL or ≥1.5 x 109/L;
    b. Platelets ≥100000/μL or ≥100 x 109/L;
    c. Hemoglobin ≥ 9 g/dL.
    9. Adequate Renal Function to be assessed within 6 days of first PF-03084014 administration, including: Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated creatinine clearance ≥ 60 ml/min as calculated using the method standard for the institution.
    10. Adequate Liver Function to be assessed within 6 days of first PF-03084014 administration, including all of the following parameters:
    a. Total serum bilirubin ≤ 1.0 x ULN ; in case of known Gilberts syndrome a total bilirubin of up to 2 x ULN is permitted.
    b. Aspartate and Alanine Aminotransferase (AST and ALT) ≤ 1.5 x ULN;
    c. Alkaline phosphatase ≤ 2.5 x ULN.
    11. Serum/urine pregnancy test (for patients of childbearing potential) negative within 6 days prior to first PF-03084014.
    12. Patients of childbearing potential (i.e. not permanently sterilized or not meeting criteria for postmenopausal status) must agree to the use of two (2) methods of highly effective contraception while receiving treatment with PF-03084014 and continued for at least 90 days after the last dose (including non-hormonal (copper-containing) intrauterine device, condom with spermicidal foam/gel/film/cream/suppository, occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam / gel / film / cream / suppository, bilateral tubal ligation or male sterilization). True abstinence is also considered a highly effective method and pairing with other contraceptive methods is not needed if patients opt for abstaining from sexual intercourse. Postmenopausal status is defined as absence of menses for 12 months preceding the initiation of neoadjuvant chemotherapy without an alternative medical cause. The use of oral hormonal contraception (combined oral contraceptive pills or progestin only pills) or contraceptive injections is not allowed for this study.

    13. Evidence of an informed consent document indicating that the patient has been informed of all pertinent aspects of the study, personally signed and dated by the subject or by the subject's legally acceptable representative, and by the investigator who conducted the informed consent discussion.
    14. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests, tumor and blood specimen collection and other procedures.
    E.4Principal exclusion criteria
    1. Concurrent treatment with chemotherapy, hormone replacement therapy, oral contraceptives, radiotherapy, bisphosphonates (either in oral, subcutaneous and intravenous administration forms), Denosumab, and any investigational therapy under evaluation in another clinical study, during the time of PF-03084014 administration.
    2. Pregnant or lactating women.
    3. Any prior history of invasive breast cancer.
    4. Any history of non-breast malignancies within the 5 years preceding study entry except for basal cell and squamous cell carcinomas of the skin or any ongoing non-breast malignancy diagnosed more than 5 years ago.
    5. Known hypersensitivity to the study drug or excipients.
    6. Any illness or medical condition that is unstable or could jeopardize the safety of the patient or her compliance with study requirements.
    7. Evidence of any residual grade 2 or worse toxicity (with the exception of alopecia) related to chemotherapy.
    8. Subjects unable to swallow oral medications.
    E.5 End points
    E.5.1Primary end point(s)
    Tumor HES4 gene expression will be evaluated using reverse transcription polymerase chain reaction (RT-PCR) at the end of the study) from FFPE tumor tissue collected before and after PF-03084014 administration period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the end of the study from FFPE tumor tissue collected before and after PF-03084014 administration period.
    E.5.2Secondary end point(s)
    Complete tumor transcriptome will be evaluated using RNA sequencing on frozen tumor tissue collected before and after administration of PF-03084014.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the end of the study.
    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 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.8.3 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 EEA7
    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
    The end of the trial is the last visit of the last patient. For each patient enrolled, participation in the study ends at the last visit occurring 28 days after surgery.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 35
    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 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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 35
    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)
    at the discretion of the treating physician.
    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 Decision2015-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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