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    Clinical Trial Results:
    A randomized phase II study evaluating different schedules of nab-Paclitaxelin metastatic breast cancer.

    Summary
    EudraCT number
    		 2012-003058-10
    Trial protocol
    		 BE   SI   IE   IT   ES   PT  
    Global end of trial date

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Mar 2021
    First version publication date
    28 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IBCSG 42-12/BIG 2-12 SNAP
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01746225
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IBCSG
    Sponsor organisation address
    Effingerstrasse 40, Bern, Switzerland, 3008
    Public contact
    IBCSG Coordinating Center, International Breast Cancer Study Group (IBCSG), +41 31389 93 91, regulatoryoffice@ibcsg.org
    Scientific contact
    IBCSG Coordinating Center, International Breast Cancer Study Group (IBCSG), +41 31389 93 91, regulatoryoffice@ibcsg.org
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    02 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Apr 2016
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of three different schedules of nab-Paclitaxel administration, as measured by progression-free survival (PFS), using the historical reference of PFS of docetaxel for first-line treatment of metastatic breast cancer.
    Protection of trial subjects
    The IBCSG has an Office for Human Research Protection (OHRP) Federal Wide Assurance (FWA00009439) and follows all of the policies and procedures that are part of that assurance. All potential subjects for this trial received a full explanation of the trial, its purpose, treatments, risks, benefits, and of other items.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jan 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovenia: 7
    Country: Number of subjects enrolled
    Spain: 42
    Country: Number of subjects enrolled
    Belgium: 33
    Country: Number of subjects enrolled
    Ireland: 61
    Country: Number of subjects enrolled
    Italy: 40
    Country: Number of subjects enrolled
    Switzerland: 75
    Worldwide total number of subjects
    258
    EEA total number of subjects
    183
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    160
    From 65 to 84 years
    98
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was activated on 30 October 2012, and the first patient was enrolled on 16 April 2013. The study was closed to enrolment on 7 August 2015. 258 patients had been accrued in 35 centers in 5 countries.

    Pre-assignment
    Screening details
    		 No screening details available.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 nab-Paclitaxel 150 mg/m2 days 1, 8, 15 every 28 days for 3 cycles, and nab-Paclitaxel 150 mg/m2 days 1, 15 every 28 days during the fourth and subsequent cycles
    Arm type
    		 Experimental

    Investigational medicinal product name
    nab-Paclitaxel
    Investigational medicinal product code
    Other name
    Abraxane
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During the induction phase, patients receive for 3 cycles: nab-Paclitaxel 125 mg/m2 IV infusion over 30 minutes on days 1, 8, 15 every 28 days In the absence of progressive disease, patients continue to the maintenance phase and receive: nab-Paclitaxel 150 mg/m2 IV infusion over 30 minutes on days 1 and 15 every 28 days

    Arm title
    		 Arm B
    Arm description
    		 Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
    Arm type
    		 Experimental

    Investigational medicinal product name
    nab-Paclitaxel
    Investigational medicinal product code
    Other name
    Abraxane
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During the induction phase, patients receive for 3 cycles: nab-Paclitaxel 125 mg/m2 IV infusion over 30 minutes on days 1, 8, 15 every 28 days In the absence of progressive disease, patients continue to the maintenance phase and receive: nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on days 1, 8 and 15 every 28 days

    Arm title
    		 Arm C
    Arm description
    		 Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
    Arm type
    		 Experimental

    Investigational medicinal product name
    nab-Paclitaxel
    Investigational medicinal product code
    Other name
    Abraxane
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During the induction phase, patients receive for 3 cycles: nab-Paclitaxel 125 mg/m2 IV infusion over 30 minutes on days 1, 8, 15 every 28 days In the absence of progressive disease, patients continue to the maintenance phase and receive: nab-Paclitaxel 75 mg/m2 IV infusion over 30 minutes on days 1, 8, 15 and 22 every 28 days

    Number of subjects in period 1 [1]
    		Arm A Arm B Arm C
    Started
    83
    86
    86
    Completed
    43
    40
    43
    Not completed
    40
    46
    43
         Consent withdrawn by subject
    5
    15
    19
         Physician decision
    14
    11
    3
         Adverse Event
    15
    12
    17
         Death
    1
    -
    1
         Continuing Treatment
    5
    8
    3
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Intention-to-treat population. Arm A had randomized 86 patient, but only 83 were analyzed. 3 patients excluded from analysis, who immediately withdrew consent or cancelled treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 nab-Paclitaxel 150 mg/m2 days 1, 8, 15 every 28 days for 3 cycles, and nab-Paclitaxel 150 mg/m2 days 1, 15 every 28 days during the fourth and subsequent cycles

    Reporting group title
    Arm B
    Reporting group description
    		 Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

    Reporting group title
    Arm C
    Reporting group description
    		 Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

    Reporting group values
    		 Arm A Arm B Arm C Total
    Number of subjects
    		 83 86 86 255
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 58 (49 to 67) 56 (45 to 65) 60 (52 to 68) -
    Gender categorical
    Units: Subjects
        Female
    		 83 86 86 255
        Male
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 nab-Paclitaxel 150 mg/m2 days 1, 8, 15 every 28 days for 3 cycles, and nab-Paclitaxel 150 mg/m2 days 1, 15 every 28 days during the fourth and subsequent cycles

    Reporting group title
    Arm B
    Reporting group description
    		 Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

    Reporting group title
    Arm C
    Reporting group description
    		 Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

    Primary: Progression-free survival (PFS)

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    End point title
    		 Progression-free survival (PFS) [1]
    End point description
    Disease response and progression will be evaluated according to the revised Response Evaluation Criteria in Solid Tumors (RECIST V 1.1) Patients may have measurable or non-measurable disease. CT can is the method to measure lesion.
    End point type
    Primary
    End point timeframe
    At the end of the third induction cycle and during maintenance nab-Paclitaxel every three months until PD
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS>7 months.
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    83 [2]
    86
    86
    Units: months
        median (confidence interval 90%)
    7.9 (6.8 to 8.4)
    9.0 (8.1 to 10.9)
    8.5 (6.7 to 9.5)
    Notes
    [2] - Three patients (either untreated or cancelled) were excluded from this final analysis
    No statistical analyses for this end point

    Secondary: Feasibility

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    End point title
    		 Feasibility
    End point description
    Whether or not the patient completed treatment according to the protocol for at least 24 weeks. Patients who progressed within 24 weeks were considered as not completing.
    End point type
    Secondary
    End point timeframe
    Baseline to 24 weeks follow-up
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    83
    86
    86
    Units: Participants
    40
    43
    44
    No statistical analyses for this end point

    Secondary: Disease Control: Overall Response of Stable Disease for a Duration of ≥24 Weeks

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    End point title
    		 Disease Control: Overall Response of Stable Disease for a Duration of ≥24 Weeks
    End point description
    Overall response of stable disease (or non-CR/non-PD for patients with non-measurable disease) for a duration of ≥24 weeks, or better (i.e., partial or complete response) according to RECIST criteria [Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.]
    End point type
    Secondary
    End point timeframe
    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    83
    86
    86
    Units: Participants
    54
    59
    52
    No statistical analyses for this end point

    Secondary: Best Overall Response

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    End point title
    		 Best Overall Response
    End point description
    Best response according to RECIST 1.1 criteria [assessed by MRI] recorded from the start of treatment across all time points until end of study treatment. Confirmation of partial or complete response by an additional scan was not requested in this trial.
    End point type
    Secondary
    End point timeframe
    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months.
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    83
    86
    86
    Units: Participants
        Complete Response (CR)
    5
    6
    4
        Partial Response (PR)
    34
    41
    35
        Stable Disease (SD)/Non-CR/Non-PD
    39
    33
    31
        Progressive Disease (PD)
    3
    5
    11
        Not Evaluable (NE)
    2
    1
    5
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    Time from randomization until death from any cause, or censored at date last known alive. No upper limit for the confidence interval was reported, as insufficient number of participants with events. For the sake of completeness a fictive value of 30 was entered.
    End point type
    Secondary
    End point timeframe
    Reported after 18.2 months median follow-up since randomization.
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    83
    86
    86
    Units: Months
        median (confidence interval 90%)
    25.8 (16.9 to 30)
    26.2 (21.0 to 30)
    25.5 (22.7 to 30)
    No statistical analyses for this end point

    Secondary: Changes in Physical Well-being (Change From Day 1 of Cycle 4 to Day 1 of Cycle 6)

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    End point title
    		 Changes in Physical Well-being (Change From Day 1 of Cycle 4 to Day 1 of Cycle 6)
    End point description
    Changes in Physical Well-being (Change From Day 1 of Cycle 4 to Day 1 of Cycle 6). Key domains will be assessed by global linear analogue self-assessment (LASA) indicator. The LASAindicators range from 0 to 100. For all QL measures higher scores reflect a better condition (e.g.,better physical well-being).
    End point type
    Secondary
    End point timeframe
    Assessed from day 1 of cycle 4 through day 1 of cycle 12.
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    66
    72
    61
    Units: Units on a scale
        arithmetic mean (confidence interval 95%)
    -2 (-9 to 5)
    1 (-6 to 7)
    4 (-4 to 11)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    An adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after the final dose, regardless of whether it is considered related to a medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 nab-Paclitaxel 150 mg/m2 days 1, 8, 15 every 28 days for 3 cycles, and nab-Paclitaxel 150 mg/m2 days 1, 15 every 28 days during the fourth and subsequent cycles

    Reporting group title
    Arm B
    Reporting group description
    		 Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

    Reporting group title
    Arm C
    Reporting group description
    		 Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

    Serious adverse events
    		 Arm A Arm B Arm C
    Total subjects affected by serious adverse events
         subjects affected / exposed
    51 / 83 (61.45%)
    43 / 86 (50.00%)
    57 / 86 (66.28%)
         number of deaths (all causes)
    1
    0
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Thyroid Cancer
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fibroids
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Thromboembolic event
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 86 (0.00%)
    3 / 86 (3.49%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 86 (1.16%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fever
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylaxis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Dyspnea
         subjects affected / exposed
    1 / 83 (1.20%)
    2 / 86 (2.33%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 86 (1.16%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Pleural effusion
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COPD Exacerbation
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 86 (1.16%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleuritic Chest Pain
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Creatinine increased
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    White blood cell decreased
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 86 (1.16%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Pericardial effusion
         subjects affected / exposed
    2 / 83 (2.41%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Supraventricular Tachycardia
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Peripheral Sensory Neuropathy
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    2 / 83 (2.41%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhea
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 86 (1.16%)
    2 / 86 (2.33%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation +/- gastritis
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 83 (0.00%)
    3 / 86 (3.49%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea and Vomiting
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 86 (1.16%)
    2 / 86 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal Calculi
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute Renal Failure
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone Fracture (Rib)
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    3 / 83 (3.61%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis of jaw
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchial infection
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 86 (0.00%)
    4 / 86 (4.65%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 86 (1.16%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Soft tissue infection
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory infection
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium Difficile Infection
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Port-a-Cath Infection
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalemia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypophosphatemia
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm A Arm B Arm C
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    78 / 83 (93.98%)
    83 / 86 (96.51%)
    80 / 86 (93.02%)
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    28 / 83 (33.73%)
    35 / 86 (40.70%)
    42 / 86 (48.84%)
         occurrences all number
    28
    35
    42
    Platelet count decreased
         subjects affected / exposed
    8 / 83 (9.64%)
    8 / 86 (9.30%)
    4 / 86 (4.65%)
         occurrences all number
    8
    8
    4
    Cardiac disorders
    Heart Failure
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 86 (0.00%)
    3 / 86 (3.49%)
         occurrences all number
    0
    0
    3
    Sinus Tachycardia
         subjects affected / exposed
    2 / 83 (2.41%)
    4 / 86 (4.65%)
    3 / 86 (3.49%)
         occurrences all number
    2
    4
    3
    Nervous system disorders
    Peripheral Sensory Neuropathy
         subjects affected / exposed
    51 / 83 (61.45%)
    58 / 86 (67.44%)
    55 / 86 (63.95%)
         occurrences all number
    51
    58
    55
    Recurrent Laryngeal nerve Palsy
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    46 / 83 (55.42%)
    55 / 86 (63.95%)
    55 / 86 (63.95%)
         occurrences all number
    46
    55
    55
    Immune system disorders
    Allergic Reaction
         subjects affected / exposed
    8 / 83 (9.64%)
    4 / 86 (4.65%)
    4 / 86 (4.65%)
         occurrences all number
    8
    4
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    32 / 83 (38.55%)
    31 / 86 (36.05%)
    40 / 86 (46.51%)
         occurrences all number
    32
    31
    40
    Vomiting
         subjects affected / exposed
    10 / 83 (12.05%)
    11 / 86 (12.79%)
    17 / 86 (19.77%)
         occurrences all number
    10
    11
    17
    Diarrhea
         subjects affected / exposed
    21 / 83 (25.30%)
    28 / 86 (32.56%)
    27 / 86 (31.40%)
         occurrences all number
    21
    28
    27
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    2 / 83 (2.41%)
    2 / 86 (2.33%)
    4 / 86 (4.65%)
         occurrences all number
    2
    2
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Sep 2014
    In the original design of this phase II trial, the induction phase planned three cycles of nab-Paclitaxel 150 mg/m2 days 1, 8, 15 every 28 days. Following the first safety review of 48 treated patients, it was decided to modify the dose in the induction phase to 125 mg/m2. The change was included in Amendment 1 (dated 11 August 2014) and this amendment was activated on 5 September 2014.
    23 Jan 2015
    Based on recommendations from the IBCSG DSMC, IBCSG decided to increase the total sample size from 240 to 258 patients. The statistical considerations (power calculations) in the protocol were adapted accordingly. Amendment 2 (dated 06 January 2015) was activated on 23 January 2015.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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