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    Summary
    EudraCT Number:2018-000157-41
    Sponsor's Protocol Code Number:UoL001343
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-04-16
    Trial 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 ConcernedUK - MHRA
    A.2EudraCT number2018-000157-41
    A.3Full title of the trial
    NEO21-RS: A phase II randomised study of the cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with oestrogen suppression therapy versus oestrogen suppression therapy alone as neoadjuvant therapy in ER-positive intermediate recurrence score primary breast cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NEO21-RS: A prospective study of the outcomes following 21-gene recurrence score directed neoadjuvant therapy in ER-positive, HER2-negative breast cancer patients
    A.3.2Name or abbreviated title of the trial where available
    NEO21-RS Study
    A.4.1Sponsor's protocol code numberUoL001343
    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 SponsorThe University of Liverpool
    B.1.3.4CountryUnited Kingdom
    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 Alliance
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportGemonic Health
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLiverpool Clinical Trials Unit
    B.5.2Functional name of contact pointEdiri O'Brien
    B.5.3 Address:
    B.5.3.1Street AddressBlock C Waterhouse Building
    B.5.3.2Town/ cityLiverpool
    B.5.3.3Post codeL69 3GL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01517957730
    B.5.6E-maileobrien@liverpool.ac.uk
    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 125mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd
    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 125mg
    D.3.4Pharmaceutical form Capsule, hard
    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 571190-30-2
    D.3.9.4EV Substance CodeAS1
    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 100mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd
    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 100mg
    D.3.2Product code L01XE33
    D.3.4Pharmaceutical form
    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 571190-30-2
    D.3.9.4EV Substance CodeAS4
    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 75mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd
    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 75mg
    D.3.4Pharmaceutical form Capsule, hard
    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 571190-30-2
    D.3.9.4EV Substance CodeAS5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ER-positive, HER2-negative breast cancer
    E.1.1.1Medical condition in easily understood language
    Early breast cancer in women that is oestrogen receptor positive and human epidermal growth factor receptor negative.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10070577
    E.1.2Term Oestrogen receptor positive 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
    The primary objective is to compare the changes in Ki67 proliferation index after 24 weeks treatment with oestrogen suppression therapy with or without palbociclib for patients with an intermediate RS score.
    E.2.2Secondary objectives of the trial
    Secondary objectives for the randomised group:
    1. To compare the objective radiological response rate as measured by ultrasound after 24 weeks treatment with oestrogen suppression therapy with or without palbociclib.
    2. To compare the objective clinical response rate after 24 weeks treatment with oestrogen suppression therapy with or without palbociclib.
    3. To compare the proportion of patients who undergo breast conservation after 24 weeks of treatment with oestrogen suppression therapy with or without palbociclib.
    4. To compare the proportion of patients with improved surgical outcome after 24 weeks of treatment with oestrogen suppression therapy with or without palbociclib.
    5. To compare the pathological complete response (pCR) rate after 24 weeks treatment with oestrogen suppression therapy with or without palbociclib.
    6. To compare the proportion of tumours with a Preoperative Endocrine Prognostic Index (PEPI) score of 0 or 1 after 24 weeks of treatment with oestrogen suppressio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • 18 years of age or older
    • Histologically confirmed invasive breast cancer
    • ER positive (Allred ≥3)
    • HER2 negative per the 2013 ASCO/CAP guidelines
    • Axillary node negative or positive
    • Tumour measuring ≥15mm in longest diameter as measured clinically or radiologically* or any size tumour with axillary node involvement
    • Candidate for neoadjuvant endocrine therapy or chemotherapy
    • Pre- or postmenopausal women
    Postmenopausal status will be defined by the presence of any one of the following criteria:
    ≥55 years of age with an intact uterus and amenorrhoea ≥12 months at the time of diagnosis
    <55 years with no menses for at least 12 months prior to study entry and documented or current FSH and oestradiol levels within the postmenopausal range (as per local institutional/laboratory standard
    >18 years with prior hysterectomy with intact ovaries and with a documented or current FSH and oestradiol level within the postmenopausal range (as per local institutional/laboratory standard)
    >18 years with prior bilateral oophorectomy
    • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
    • Adequate bone marrow function defined by Hb≥10 g/dl, ANC >1.5 x109, PLT≥100 x109/L.
    • Adequate renal function defined by a serum creatinine ≤1.5 x ULN. Adequate liver function defined by total bilirubin ≤ 1.5 ULN (patients with Gilbert’s syndrome exempted), either ALT or AST ≤1.5 ULN and ALP ≤1.5 ULN
    • No contraindications to receiving palbociclib
    • Written informed consent, able to comply with treatment and follow-up.
    E.4Principal exclusion criteria
    • Inflammatory breast cancer
    • Evidence of metastatic disease prior to 21-gene recurrence score assay testing
    • Any history of invasive malignancy within 5 years of starting study treatment (other than adequately treated basal cell carcinoma or squamous cell carcinoma of the skin and cervical carcinoma in situ)
    • Surgical axillary staging procedure prior to study procedure (with the exception of FNA or core biopsy)
    • Evidence of bleeding diathesis
    • Prior endocrine therapy or chemotherapy for breast cancer
    • Concomitant use (defined as use within 4 weeks prior to entry) of HRT or any other oestrogen-containing medication or supplement (including vaginal oestrogens and phytoestrogens)
    • Uncontrolled abnormalities of serum potassium, sodium, calcium or magnesium levels
    • Use of CYP3A inhibitors or inducers
    • Evidence of uncontrolled active infection
    • Evidence of significant medical condition or laboratory findings which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial
    • Pregnant or breastfeeding
    E.5 End points
    E.5.1Primary end point(s)
    For the RCT the primary outcome is the change in level of proliferation marker Ki67 from baseline to 24 weeks.

    Note that for the observational cohort all outcomes are secondary, although the change in level of proliferation marker Ki67 will be assessed.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline tissue sample taken from diagnostic biopsy (up to 28 days prior to study registration/randomisation) and a further tissue sample taken the end of treatment at 24 weeks.
    E.5.2Secondary end point(s)
    Secondary endpoints for the RCT interventional cohort i.e. the intermediate recurrence score group treated with oestrogen suppression therapy or oestrogen suppression plus palbociclib are as follows:
    • Objective of radiological response as measured by ultrasound after 24 weeks of treatment according to the ECOG criteria.
    • Objective clinical response after 24 weeks of treatment according to the ECOG criteria.
    • Breast conservation after 24 weeks of treatment.
    • Improved surgical outcome after 24 weeks of treatment.
    • Pathological complete response (pCR) after 24 weeks of treatment.
    • Preoperative Endocrine Prognostic Index (PEPI) score after 24 weeks.
    • Adjuvant chemotherapy after surgery.
    • Safety and tolerability in terms of:
    o grade 3+ toxicity classified by NCI-CTCAE v 4.0.
    o serious adverse events
    o withdrawal from trial treatment due to toxicity
    o experience of delay to scheduled surgery due to treatment related toxicities

    Secondary endpoints for the observational cohort i.e. low recurrence score group treated with oestrogen suppression therapy and high recurrence score group treated with chemotherapy:
    • Objective of radiological response as measured by ultrasound after 24 weeks of treatment according to the ECOG criteria.
    • Objective clinical response after 24 weeks of treatment according to the ECOG criteria.
    • Breast conservation after 24 weeks of treatment.
    • Improved surgical outcome after 24 weeks of treatment.
    • Pathological complete response (pCR) after 24 weeks of treatment.
    • Preoperative Endocrine Prognostic Index (PEPI) score after 24 weeks.
    • Adjuvant chemotherapy after surgery.
    • Level of Ki67 proliferation marker at baseline and at 24 weeks.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and end of treatment at 24 weeks/surgery
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    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
    Control arm is oestrogen suppression therapy alone
    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 concerned15
    E.8.5The trial involves multiple Member States No
    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 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
    The end of the trial will be the last visit (4-weeks post-surgery) of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 118
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state118
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 118
    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)
    The study IMP is provided for neoadjuvant treatment only for a period of 24 weeks, at which time point surgery will be scheduled. Following surgery, adjuvant treatment may be offered as per standard care. However, palbociclib will not be provided for ongoing adjuvant treatment.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation CRN North West Coast
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-26
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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