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    Summary
    EudraCT Number:2016-004191-22
    Sponsor's Protocol Code Number:PH001Precycle
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2017-03-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-004191-22
    A.3Full title of the trial
    PRECYCLE: Multicenter, randomized phase IV intergroup trial to evaluate the impact of e Health-based patient reported outcome (PRO) assessment on quality of life in patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer treated with Palbociclib and an aromatase inhibitor- or Palbociclib and Fulvestrant
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of eHealth-support on Quality of Life in metastatic breast cancer patients treated with Palbociclib and endocrine therapy
    A.3.2Name or abbreviated title of the trial where available
    PreCycle
    A.4.1Sponsor's protocol code numberPH001Precycle
    A.5.4Other Identifiers
    Name:AGO-BNumber:AGOB002
    Name:AGO-TraFoNumber:TraFO002-16
    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 SponsorPalleos healthcare GmbH
    B.1.3.4CountryGermany
    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 supportPfizer Pharma GmbH
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportGEMKOM e.V, (Gesellschaft für moderne Kommunikation in der Medizin)
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportUniversitätsklinikum Erlangen, Frauenklinik Labor für Molekulare Medizin
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportArbeitsgemeinschaft gynäkologische Onkologie Kommission Mamma (AGO-B)
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportArbeitsgemeinschaft gynäkologische Onkologie Kommission Translationale Forschung (AGO-TraFo)
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportWestdeutsche Studiengruppe (WSG)
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportDeutsche Gesellschaft für hämatologische Onkologie (DGHO)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPalleos healthcare GmbH
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressTaunusstrasse 5a
    B.5.3.2Town/ cityWiesbaden
    B.5.3.3Post code65183
    B.5.3.4CountryGermany
    B.5.4Telephone number00496119501900
    B.5.5Fax number004961195019029
    B.5.6E-mailnicoletta.scheller@palleos.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 125mg Filmtabletten
    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.3.4Pharmaceutical 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 571190-30-2
    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.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFulvestrant
    D.3.9.1CAS number 129453-61-8
    D.3.9.3Other descriptive nameFULVESTRANT
    D.3.9.4EV Substance CodeSUB13933MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.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.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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 INNAnastrozole
    D.3.9.1CAS number 120511-73-1
    D.3.9.3Other descriptive nameANASTROZOLE
    D.3.9.4EV Substance CodeSUB05502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 4
    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.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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 INNLETROZOLE
    D.3.9.1CAS number 112809-51-5
    D.3.9.4EV Substance CodeSUB08444MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2,5
    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: 5
    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.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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 INNExemestan
    D.3.9.1CAS number 107868-30-4
    D.3.9.3Other descriptive nameEXEMESTANE
    D.3.9.4EV Substance CodeSUB07492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    advanced and or metastatic breast cancer
    E.1.1.1Medical condition in easily understood language
    advanced and or metastatic breast cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 superiority w.r.t. time to deterioration (TTD) of quality of life for patients with eHealth-based high density observation using CANKADO (CANKADO active) versus eHealth-based static observation on site (CANKADO inform).
    E.2.2Secondary objectives of the trial
    i. Sensitivity Analysis: To compare TTD DQoL between the two treatment arms in terms of DQoL as minimally important difference (5-point drop on FACT-G).
    ii. To demonstrate that an eHealth-based high density observation using CANKADO does not have a negative impact on clinical outcome (PFS, OS).
    iii. To analyze the effect of patient reported outcome (PRO; data of daily drug intake behavior, global health status, quality of life) w.r.t. clinical outcome (PFS, OS) and DQoL
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:
    1. Women 18 years of age or older, who are either:
    • Post-menopausal, as defined by at least one of the following criteria:
    - Age ≥ 60 years;
    - Age <60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; or serum
    estradiol and FSH level within the laboratory’s reference range for post-menopausal females;
    - Documented bilateral oophorectomy;
    - Medically confirmed ovarian failure.
    OR
    - Pre/peri-menopausal, i.e., not meeting the criteria for being postmenopausal.
    - Pre/peri-meopausal women can be enrolled if amenable to be treated with a
    LHRH-agonist. Patients should be treated with a LHRH-agonist.
    2. Patients have to have metastatic disease or locally advanced (non-operable) breast cancer disease.
    3. Patients who are appropriate candidates for aromatase inhibitor + palbociclib combination
    OR
    Patients having already received endocrine therapy who are appropriate candidates for fulvestrant + palbociclib combination therapy
    4. Patient has not received prior treatment of locally advanced or metastatic disease
    OR
    Patient has received one prior line of chemotherapy and / or a maximum of two endocrine therapy lines for locally advanced or metastatic disease
    5. Peri-/pre-menopausal patients should additionally receive a LHRH-agonist
    6. The tumor has to be hormone-receptor positive (ER-positive and/or PR-positive tumor (≥ 1% positive stained cells).
    7. The tumor has to be HER2-negative defined as either HER2 immunohistochemistry Score 0 or 1+ or as HER2-negative by ISH.
    8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    9. Adequate organ and bone marrow function confirmed before palbociclib treatment start on C1D1, evidenced by the following laboratory results below:
    - absolute neutrophil count ≥ 1500 cells/μL,
    platelet count ≥ 100000 cells/μL,
    - hemoglobin ≥ 9 g/dL
    - ALT (SGPT) ≤ 2.0 × ULN (≤ 3.0 × ULN in case of liver metastases)
    - AST (SGOT) ≤ 2.0 × ULN (≤ 3.0 × ULN in case of liver metastases)
    - bilirubin ≤ 1.5 × ULN (with the exception of Gilbert’s syndrome)
    - creatinine ≤ 2.0 mg/dl or 177μmol/L
    10. In case of patients of child bearing potential:
    Negative pregnancy test (urine or serum) at baseline (within 7 days prior to randomization). Patient must agree to use highly effective non-hormonal contraceptive methods that result in a failure rate of < 1% per year, (intrauterine device (IUD), bilateral tubal occlusion, vasectomised partner1, sexual abstinence2 ) beginning 2 weeks before the first dose of investigational medicinal product (IMP) and for 2 years after the last dose of study treatment.
    11. Resolution of all acute toxic effects of prior therapy, including radiotherapy grade <1 (except toxicities not considered a safety risk for the patient) and recovery from surgical procedures
    12. Patients who are able and willing to sign the informed consent form
    13. Willingness and capability to use CANKADO
    14. Availability of hardware: Computer and/or tablet and/or smartphone with internet access
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:

    1. Known hypersensitivity to aromatase inhibitor, fulvestrant, Palbociclib or any of its excipients

    1 Provided that the partner is the sole sexual partner of the patient and that the vasectomised partner has
    received medical assessment of the surgical success.
    2 Sexual abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.

    2. Contraindication for aromatase inhibitor, fulvestrant or palbociclib; or LHRH-agonists if pre-menopausal
    3. Prior treatment with any CDK inhibitor.
    4. Patients with locally advanced or metastatic, symptomatic, visceral spread, who are at risk of life threatening complications in the short term
    5. Known active, uncontrolled or symptomatic CNS metastases
    6. Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4
    7. High cardiovascular risk, including, but not limited to recent myocardial infarction, severe/unstable angina, or severe cardiac dysrhythmias in the past 6 months prior to enrollment.
    8. Diagnosis of any second malignancy within the last 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
    9. Participation in other studies involving investigational drug(s) (Phases 1-4) within 2 weeks before the current study begins and/or during study participation.
    10. Lactating women
    11. Life expectancy < 3 months
    12. Known infection with HIV, hepatitis B virus, or hepatitis C virus
    13. Concurrent severe, uncontrolled systemic disease, social or psychiatric condition that might interfere with the planned treatment and with the patient’s adherence to the protocol
    14. legal incapacity or limited legal capacity
    E.5 End points
    E.5.1Primary end point(s)
    • TTD (time to deterioration) with respect to DQoL (deterioration of quality of life as a 10-point drop on FACT-G)

    Time to deterioration (TTD) with respect to DQoL is defined as the difference between time of treatment allocation (randomization) and time of DQoL. Patients not meeting deterioration criteria are to be censored at death or a maximum of 48 months of follow-up after treatment allocation.

    The event “deterioration of quality of life” (DQoL) is defined as any decrease of 10 or more points from baseline in QoL as assessed using the FACT-G scale, unless a recovery is achieved in the subsequent assessment. A recovery is defined as a QoL score no worse than 9 points below baseline. If data of the subsequent visit is missing, a decrease of 10 or more points will be considered as event.
    The definition of DQoL as a 10-point decrease on the FACT-G scale is based on Cella et al. (2002) and corresponds to a mean change from baseline in a subgroup of various cancer patients who classified the change as “minimally worse” according to a global rating of change (GRC) scale administered immediately after the FACT-G.
    Note that Eton et al. (2004) also suggested a 5-6 points change on FACT-G as minimally important difference (MID) in metastatic breast cancer patients. It is expected that the conservative choice of a 10-point decrease will be more robust against less meaningful fluctuations of the QoL measurement time series in the context of the precycle trial.
    A definition of DQoL in terms of MID (5-point decrease on FACT-G) will be used for sensitivity analyses in a dedicated secondary objective.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients in Arm A have to complete the EQ-VAS scale and document their drug intake daily. Additionally a FACT-B questionnaire can be triggered if the reported health status on the EQ-VAS scale changes by 10 or more score points in comparison to the mean value of the last three days or over a period of seven days compared to the mean value of seven days before.
    Patients in Arm B will be provided with FACT-B questionnaire on-site and can document the daily drug intake.

    For both study arms patients have to fill in the FACT-B questionnaire on-site on day 1 of every planned study visit during active treatment phase. In the event of dose interruptions when patients must come on-site more often than for the scheduled visits they may also be requested to complete the FACT-B questionnaire.
    E.5.2Secondary end point(s)
    Secondary Objectives:
    i. Sensitivity Analysis: To compare TTD DQoL between the two treatment arms in terms of DQoL as minimally important difference (5-point drop on FACT-G).
    ii. To demonstrate that an eHealth-based high density observation using CANKADO does not have a negative impact on clinical outcome (PFS, OS).
    iii. To analyze the effect of patient reported outcome (PRO; data of daily drug intake behavior, global health status, quality of life) w.r.t. clinical outcome (PFS, OS) and DQoL.

    Endpoints:
    • PFS (progression-free survival)
    • OS (overall survival)
    • DQoL (deterioration of quality of life)

    Progression-free survival (PFS) is considered to be the main clinical outcome and is defined as the time between treatment allocation and either first documentation of objective progression of disease (PD, as assessed by Investigator) or death due to any cause in absence of PD.

    Overall survival is defined as the time between treatment allocation and death due to any cause.

    The event “deterioration of quality of life” (DQoL) is defined as any decrease of 10 or more points from baseline in QoL as assessed using the FACT-G scale, unless a recovery is achieved in the subsequent assessment. A recovery is defined as a QoL score no worse than 9 points below baseline. If data of the subsequent visit is missing, a decrease of 10 or more points will be considered as event.
    The definition of DQoL as a 10-point decrease on the FACT-G scale is based on Cella et al. (2002) and corresponds to a mean change from baseline in a subgroup of various cancer patients who classified the change as “minimally worse” according to a global rating of change (GRC) scale administered immediately after the FACT-G.
    Note that Eton et al. (2004) also suggested a 5-6 points change on FACT-G as minimally important difference (MID) in metastatic breast cancer patients. It is expected that the conservative choice of a 10-point decrease will be more robust against less meaningful fluctuations of the QoL measurement time series in the context of the precycle trial.
    A definition of DQoL in terms of MID (5-point decrease on FACT-G) will be used for sensitivity analyses in a dedicated secondary objective.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Outcome Measure(s) and Timepoint(s):
    - PFS (progression-free survival): every 3 months as long as under study treatment
    - OS (overall survival): every 12 months under study treatment and during follow up phase
    - DQoL (deterioration of quality of life): every 28 days as long sa under study treatment
    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 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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To assess the impact of an eHealth-supported therapy management on Quality of Life in patients treated with Palbociclib in combination with endocrine therapy with HR+, HER2-advanced/metastatic breast cancer
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    CANKADO active versus CANKADO inform
    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 concerned80
    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
    A participant is considered to have completed the study if she has completed the active treatment phase until objective investigator assessed disease progression and survival follow-up until end of study visit scheduled at the end of month 48 calculated from randomization or patient’s death whatever occurs first.
    The end of the study is defined as the date of the end of treatment visit of the last participant in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 320
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 640
    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 state960
    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)
    Following the End-of-Treatment visit, survival status will be recorded in all patients
    (telephone contact is acceptable) every 12 months ±14 days), calculated from the date of randomization. Information on start, stop and type of subsequent anticancer therapy will also be collected.
    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 Arbeitsgemeinschaft gynäkologische Onkologie Kommission Mamma (AGO-B)
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Arbeitsgemeinschaft gynäkologische Onkologie Kommission Translationale Forschung (AGO-TraFo)
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Westdeutsche Studiengruppe (WSG)
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Deutsche Gesellschaft für hämatologische Onkologie (DGHO)
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-20
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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