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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   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).

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    Summary
    EudraCT Number:2015-001603-32
    Sponsor's Protocol Code Number:iOM-04318
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-02-04
    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 ConcernedGermany - BfArM
    A.2EudraCT number2015-001603-32
    A.3Full title of the trial
    An open-label, multi-center, sINGlE arm clinical study to evaluate treatment efficacy and quality of life in women with hormone-receptor-positive, HER2-negative loco-regionally recurrent or metastatic breast cancer receiving palbociclib (PD 0332991) in combination with an aromatase inhibitor, or fulvestrant after prior endocrine therapy (INGE-B)
    Eine offene, multizentrische, einarmige klinische Studie zur Evaluierung der Wirksamkeit und Lebensqualität unter Palbociclib in Kombination mit einem Aromatasehemmer oder mit Fulvestrant nach vorheriger endokriner Therapie bei Frauen mit Hormonrezeptor-positivem, HER2-negativem lokal fortgeschrittenen oder metastasierten Brustkrebs
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial in patients with advanced breast cancer (hormone receptor-positive, HER2-negative) receiving palbociclib and standard therapy with an aromatase inhibitor or fulvestrant after prior endocrine therapy.
    A.3.2Name or abbreviated title of the trial where available
    INGE-B
    A.4.1Sponsor's protocol code numberiOM-04318
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02894398
    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 SponsoriOMEDICO AG
    B.1.3.4CountryGermany
    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 Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationiOMEDICO AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressEllen-Gottlieb-Str. 19
    B.5.3.2Town/ cityFreiburg i.Br.
    B.5.3.3Post code79106
    B.5.3.4CountryGermany
    B.5.4Telephone number+49761152420
    B.5.5Fax number+497611524280
    B.5.6E-mailinfo@iomedico.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 Yes
    D.2.1.1.1Trade name Ibrance
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameIbrance
    D.3.2Product code PD 0332991
    D.3.4Pharmaceutical form Film-coated 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 INNPalbociclib
    D.3.9.1CAS number 827022-32-2
    D.3.9.2Current sponsor codePD 0332991
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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.IMP: 2
    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 Ibrance
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameIbrance
    D.3.2Product code PD 0332991
    D.3.4Pharmaceutical form Film-coated 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 INNPALBOCICLIB
    D.3.9.1CAS number 827022-32-2
    D.3.9.2Current sponsor codePD 0332991
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 3
    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 Ibrance
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameIbrance
    D.3.2Product code PD 0332991
    D.3.4Pharmaceutical form Film-coated 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 INNPALBOCICLIB
    D.3.9.1CAS number 827022-32-2
    D.3.9.2Current sponsor codePD 0332991
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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
    The study population includes postmenopausal patients with advanced (locally recurrent, inoperable and/or metastatic), HR+, HER2- breast cancer. For peri-/premenopausal patients, endocrine therapy has to be combines with a luteinizing hormone-releasinghormone (LRHR) agonist.
    E.1.1.1Medical condition in easily understood language
    The study includes peri-/premenopausal and postmenopausal women with advances hormone receptor postive, HER2- breat cancer
    Peri-/prämenopausale und postmenopausale Patientinnen mit fortgeschrittener, hormonrezeptor positiver, HER2- negativer Brustkrebsekrankung )können eingeschlossen werden.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10072737
    E.1.2Term Advanced breast cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10070575
    E.1.2Term Estrogen receptor positive breast cancer
    E.1.2System Organ Class 100000004864
    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 palbociclib in addition to an aromatase inhibitor or fulvestrant after prior endocrine therapy in pre-/perimenopausal and postmenopausal women with HR+/HER2- advanced breast cancer (locally advanced, inoperable or metastatic) as first or later-line of treatment.
    E.2.2Secondary objectives of the trial
    -To assess safety and tolerability
    -To assess efficacy
    -To assess treatment adherence
    -To assess health-related quality of life (QoL), fatigue, and anxiety and depression
    -To compare quality of life with real-life patients receiving first-line chemotherapy in the non-interventional MaLife study
    -To physician’s assessment of patient’s overall health status and change in health status
    -To explore whether organ-specific symptoms can serve as indicators for progressive disease
    -To establish a decentral, virtual biobank for the future collection and central analyses of predictive biomarkers of the CDK4/6 pathway
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with proven diagnosis of advanced adenocarcinoma of the breast (locally advanced, inoperable or metastatic disease).
    - Patients with hormone-receptor-positive (HR+) disease, defined as ER+ and/or PgR+
    - Patients with human-epidermal-growth-factor-receptor-2-negative (HER2-) disease
    - Pre-/perimenopausal women receiving concomitant therapy with an luteinizing hormone-releasing hormone (LHRH) agonist or postmenopausal status
    - Patients scheduled for palliative treatment with the combination of palbociclib and letrozole for first- or later-line, anastrozole for first-line, exemestane for first-line, or fulvestrant for first-or later-line after prior endocrine failure.
    - Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    E.4Principal exclusion criteria
    - Patient has received prior treatment with any CDK inhibitor
    - Prior adjuvant therapy with the respective endocrine combination partner if last intake <12 months prior to entering the study
    - Prior palliative therapy with the respective endocrine combination partner
    - More than one palliative chemotherapy for patients in treatment group 5 (second or later line, Palbociclib and Letrozole) and group 6 (Second or leter line, Palbociclib and Fulvestrant after prior endocrine therapy)
    - Patient has known, not-irradiated CNS metastases
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint of this study is to determine the
    Clinical Benefit Response (CBR) defined as proportion of patients with best overall response
    CBR is defined as complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 24 weeks after start of treatment with palbociclib and the respective combination partner.
    E.5.2Secondary end point(s)
    To assess safety and tolerability
    - Adverse Events as characterized by type, frequency, severity (as graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v.4.03), and seriousness until PD (or start of next anti-cancer therapy, whatever comes first)
    - Any laboratory abnormalities
    - Frequency and duration of hospitalizations
    To assess efficacy
    - CBR ≥24 weeks
    - Progression free survival (PFS)
    - Overall survival (OS)
    - CBR at 48 weeks of treatment
    - PFS rate after 48 weeks (all patients) and after 2 years of treatment (first-line patients only)
    - OS rate after 48 weeks (all patients), thereafter yearly until EOS (first-line patients only)ly)
    To assess treatment adherence
    - Time on treatment
    - Reasons for discontinuation of treatment
    - Dose adjustments (frequency, reason)
    - Patient diary until EOT
    To assess Health-related quality of life (QoL), fatigue, and anxiety and depression
    - Health-related QoL will be assessed with the FACT-B (Functional Assessment of Cancer Therapy-Breast) questionnaire every 12 weeks until PD (or start of next anti-cancer therapy, whatever comes first)
    - Fatigue will be assessed with the BFI (Brief Fatigue Inventory) questionnaire every 12 weeks until PD (or start of next anti-cancer therapy, whatever comes first)
    - Depression and anxiety be assessed with the HADS-D (Hospital Anxiety and Depression Scale) questionnaire every 12 weeks until PD (or start of next anti-cancer therapy, whatever comes first)
    To assess Physician’s assessment of patient’s overall health status and change in health status compared to previous visit
    - Assessed with 2 item questionnaire each cycle/at scheduled patient visit until progression of disease or start of next anti-cancer therapy whatever comes first.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see above
    Either at 24 weeks, at 48 weeks, after 2 years or at time point of progressive disease or start of next anti cancer therapy
    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 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 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 Yes
    E.8.1.7.1Other trial design description
    Einarmig
    Single arm
    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 concerned80
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA85
    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 entire study is defined as LPLV.
    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 months3
    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 months3
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 state350
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 360
    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)
    If patients discontinue study treatment (e.g. due to progression or toxicity) the investigator will offer appropriate treatment options to current knowledge and treatment standards.
    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 Decision2016-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-15
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