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    Clinical Trial Results:
    Randomized, open label, multicentric phase III trial evaluating the benefit of a sequential regimen associating FEC100 and Ixabepilone in adjuvant treatment of non metastatic, poor prognosis breast cancer defined as triple-negative tumor (HER2 negative - ER negative - PR negative) or HER2 negative and PR negative tumor; in node positive or node negative patients.

    Summary
    EudraCT number
    		 2006-006494-24
    Trial protocol
    		 FR   BE  
    Global end of trial date
    03 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jan 2025
    First version publication date
    05 Jan 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    PACS 08/0610
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00630032
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UNICANCER
    Sponsor organisation address
    101 rue de Tolbiac, Paris, France, 75013
    Public contact
    Nourredine AIT RAHMOUNE, UNICANCER, 33 0171936704, n.ait-rahmoune@unicancer.fr
    Scientific contact
    Nourredine AIT RAHMOUNE, UNICANCER, 33 0171936704, n.ait-rahmoune@unicancer.fr
    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
    Final
    Date of interim/final analysis
    28 Mar 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Mar 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Sep 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of this trial is to evaluate in non-metastatic, poor-prognosis breast cancer women the benefit from the sequential administration of 3 FEC100 followed by 3 cycles of Ixabepilone versus standard epirubicin + docetaxel based protocol on the disease-free survival at 5 years.
    Protection of trial subjects
    This study was conducted in accordance with: -the principles of ethics as stated in the last version in use of the Declaration of Helsinki, - the Good Clinical Practices defined by the International Conference on Harmonization (ICH–E6, 17/07/96), - the European directive 2001/20/CE on the conduct of clinical trials, - Huriet’s law (n° 88-1138) of December 20 th , 1988, relative to the protection of persons participating in biomedical research and modified by the Public Health Law n°2004-806 of August 9 th , 2004, - the law on ‘informatics and freedom’ (Informatique et Libertés n° 78-17) of January 6th,1978 modified by the law n° 2004-801 of August 6 th, 2004 relative to the protection of persons with regard to the computerized processing of personal data, - bioethic law n° 2004-800 of August 6, 2004.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Oct 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 166
    Country: Number of subjects enrolled
    France: 571
    Country: Number of subjects enrolled
    United States: 25
    Worldwide total number of subjects
    762
    EEA total number of subjects
    737
    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)
    667
    From 65 to 84 years
    95
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 PACS 08 is an open label, multicentric randomized phase III trial, comparing two treatment arms: sequential regimen (3 FEC100 + 3 docetaxel), versus sequential regimen (3 FEC100 + 3 ixabepilone) in the treatment of non metastatic, operable, poor prognosis breast cancer. 762 patients were included in 88 centres, between 17/10/2007 and 03/09/2010.

    Pre-assignment
    Screening details
    		 Prior to entering the PACS-08 trial, the triple negative or PR-/HER2- status of all patients was confirmed by a regional referent pathologist to confirm the eligibility of the patients before randomization. The treatment must begin within 49 days following the date of surgery.

    Period 1
    Period 1 title
    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: 3 FEC 100 + 3 Docetaxel
    Arm description
    		 Patients received: • 3 cycles (1 every 21 days, cycle 1 to 3) of FEC100 consisting of epirubicin 100 mg/m² and 5-fluorouracil 500 mg/m² and cyclophosphamide 500 mg/m² • Then 3 cycles (1 every 21 days, cycle 4 to 6) of docetaxel cycles 100 mg/m²
    Arm type
    		 Active comparator

    Investigational medicinal product name
    5-Fluorouracil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 mg/m² every 3 weeks

    Investigational medicinal product name
    Epirubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100 mg/m² every 3 weeks

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 mg/m² every 3 weeks

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100 mg/m² every 3 weeks

    Arm title
    		 Arm B: 3 FEC 100 + 3 Ixabepilone
    Arm description
    		 Patients received: • 3 cycles (1 every 21 days, cycle 1 to 3) of FEC100 consisting of epirubicin 100 mg/m² and 5-fluorouracil 500 mg/m² and cyclophosphamide 500 mg/m² • Then 3 cycles (1 every 21 days, cycle 4 to 6) of ixabepilone cycles 40 mg/m²
    Arm type
    		 Experimental

    Investigational medicinal product name
    5-Fluorouracil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 mg/m² every 3 weeks

    Investigational medicinal product name
    Epirubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100 mg/m² every 3 weeks

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 mg/m² every 3 weeks

    Investigational medicinal product name
    Ixabepilone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 mg/m² every 3 weeks

    Number of subjects in period 1
    		ARM A: 3 FEC 100 + 3 Docetaxel Arm B: 3 FEC 100 + 3 Ixabepilone
    Started
    398
    364
    Completed
    371
    332
    Not completed
    27
    32
         Relapse
    1
    -
         Consent withdrawal
    4
    -
         Toxicity
    12
    26
         MIssing
    1
    -
         Other
    8
    -
         Lost to follow-up
    1
    -
         Protocol deviation
    -
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ARM A: 3 FEC 100 + 3 Docetaxel
    Reporting group description
    		 Patients received: • 3 cycles (1 every 21 days, cycle 1 to 3) of FEC100 consisting of epirubicin 100 mg/m² and 5-fluorouracil 500 mg/m² and cyclophosphamide 500 mg/m² • Then 3 cycles (1 every 21 days, cycle 4 to 6) of docetaxel cycles 100 mg/m²

    Reporting group title
    Arm B: 3 FEC 100 + 3 Ixabepilone
    Reporting group description
    		 Patients received: • 3 cycles (1 every 21 days, cycle 1 to 3) of FEC100 consisting of epirubicin 100 mg/m² and 5-fluorouracil 500 mg/m² and cyclophosphamide 500 mg/m² • Then 3 cycles (1 every 21 days, cycle 4 to 6) of ixabepilone cycles 40 mg/m²

    Reporting group values
    		 ARM A: 3 FEC 100 + 3 Docetaxel Arm B: 3 FEC 100 + 3 Ixabepilone Total
    Number of subjects
    		 398 364 762
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 50 45 95
        From 65-84 years
    		 348 319 667
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 53.5 (24 to 70) 53 (26 to 71) -
    Gender categorical
    Units: Subjects
        Female
    		 398 364 762
        Male
    		 0 0 0
    ECOG
    Units: Subjects
        ECOG 0
    		 311 277 588
        ECOG 1
    		 35 31 66
        Missing
    		 52 56 108
    Menopausal status
    Units: Subjects
        Premenopausal
    		 167 155 322
        Postmenopausal
    		 231 209 440
    Sex
    Units: Subjects
        Male
    		 0 1 1
        Female
    		 398 363 761
    ER / PR combination
    Units: Subjects
        ER+/PR+
    		 6 2 8
        ER-/PR-
    		 307 280 587
        ER+/PR-
    		 85 82 167
        ER-/PR+
    		 0 0 0
    HER2 status
    Units: Subjects
        Negative
    		 397 363 760
        Positive
    		 1 1 2
    Receptors
    TNBC: stands for triple negative breast cancer
    Units: Subjects
        TNBC [ER-/PR-/HER2-]
    		 307 279 586
        ER+/PR-/HER2-
    		 85 82 167
        Missing
    		 6 3 9
    TNBC: (ER-/PR-/HER2-)
    TNBC: stands for triple negative breast cancer
    Units: Subjects
        No
    		 242 238 480
        Yes
    		 155 126 281
        Missing
    		 1 0 1
    Estrogen Receptor
    Units: Subjects
        Yes
    		 296 268 564
        Missing
    		 102 96 198
    Progesteron Receptor
    Units: Subjects
        Yes
    		 288 263 551
        Missing
    		 110 101 211

    End points

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    End points reporting groups
    Reporting group title
    ARM A: 3 FEC 100 + 3 Docetaxel
    Reporting group description
    		 Patients received: • 3 cycles (1 every 21 days, cycle 1 to 3) of FEC100 consisting of epirubicin 100 mg/m² and 5-fluorouracil 500 mg/m² and cyclophosphamide 500 mg/m² • Then 3 cycles (1 every 21 days, cycle 4 to 6) of docetaxel cycles 100 mg/m²

    Reporting group title
    Arm B: 3 FEC 100 + 3 Ixabepilone
    Reporting group description
    		 Patients received: • 3 cycles (1 every 21 days, cycle 1 to 3) of FEC100 consisting of epirubicin 100 mg/m² and 5-fluorouracil 500 mg/m² and cyclophosphamide 500 mg/m² • Then 3 cycles (1 every 21 days, cycle 4 to 6) of ixabepilone cycles 40 mg/m²

    Subject analysis set title
    TNBC (ER-/PR-/HER2-)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Triple-negative breast cancer (TNBC) are characterized by tumor cells which do not express any of markers: estrogen receptor (ER), the progesterone receptor (PR), and where the human epidermal growth factor 2 (ERBB2; formerly known as HER2).

    Subject analysis set title
    ER+/PR-/HER2-
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    non-TNBC (ER+/PR-/HER2-) are characterized by tumor cells which estrogen receptor (ER) positive, but do not express any of the progesterone receptor (PR) and where the human epidermal growth factor 2 (ERBB2; formerly known as HER2)

    Primary: Disease-Free Survival (DFS) at 5-years

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    End point title
    		 Disease-Free Survival (DFS) at 5-years
    End point description
    The Disease-Free Survival (DFS) was defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first.
    End point type
    Primary
    End point timeframe
    5 years
    End point values
    		 ARM A: 3 FEC 100 + 3 Docetaxel Arm B: 3 FEC 100 + 3 Ixabepilone TNBC (ER-/PR-/HER2-) ER+/PR-/HER2-
    Number of subjects analysed
    398
    364
    586
    167
    Units: percent
        number (confidence interval 95%)
    79 (74.5 to 82.7)
    83.4 (79.1 to 86.9)
    0.77 (0.54 to 1.12)
    0.86 (0.65 to 1.64)
    Statistical analysis title
    		 DSF analysis
    Comparison groups
    ARM A: 3 FEC 100 + 3 Docetaxel v Arm B: 3 FEC 100 + 3 Ixabepilone
    Number of subjects included in analysis
    762
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.175
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 1.1

    Secondary: Distant Metastasis-Free Survival (DMFS) at 5-years

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    End point title
    		 Distant Metastasis-Free Survival (DMFS) at 5-years
    End point description
    Distant Metastasis-Free Survival (DMFS) at 5-years is defined by the absence metastatic relapse or death from any cause.
    End point type
    Secondary
    End point timeframe
    at 5 years
    End point values
    		 ARM A: 3 FEC 100 + 3 Docetaxel Arm B: 3 FEC 100 + 3 Ixabepilone TNBC (ER-/PR-/HER2-) ER+/PR-/HER2-
    Number of subjects analysed
    398
    364
    586
    167
    Units: percent
        number (confidence interval 95%)
    82.3 (78.1 to 85.8)
    87.7 (83.8 to 90.7)
    0.58 (0.37 to 0.91)
    1.04 (0.53 to 2.01)
    Statistical analysis title
    		 DMFS analysis
    Comparison groups
    ARM A: 3 FEC 100 + 3 Docetaxel v Arm B: 3 FEC 100 + 3 Ixabepilone
    Number of subjects included in analysis
    762
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.065
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 1.02

    Secondary: Event-Free Survival (EFS) at 5-years

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    End point title
    		 Event-Free Survival (EFS) at 5-years
    End point description
    The Event-Free Survival (EFS) at 5-years is defined by the absence of an event (i.e., a local, regional or metastatic relapse, a contralateral breast cancer, a secondary cancer, or a death from any cause).
    End point type
    Secondary
    End point timeframe
    5 years
    End point values
    		 ARM A: 3 FEC 100 + 3 Docetaxel Arm B: 3 FEC 100 + 3 Ixabepilone
    Number of subjects analysed
    398
    364
    Units: percent
        number (confidence interval 95%)
    77.1 (72.3 to 81.1)
    80.7 (76.0 to 84.6)
    Statistical analysis title
    		 EFS analysis
    Comparison groups
    ARM A: 3 FEC 100 + 3 Docetaxel v Arm B: 3 FEC 100 + 3 Ixabepilone
    Number of subjects included in analysis
    762
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.148
    Method
    		 Logrank
    Parameter type
    		 Log hazard ratio
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 1.08

    Secondary: Overall Survival (OS) at 5-years

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    End point title
    		 Overall Survival (OS) at 5-years
    End point description
    The Overall Survival (OS) at 5-years is defined by the absence of death from any cause.
    End point type
    Secondary
    End point timeframe
    5 years
    End point values
    		 ARM A: 3 FEC 100 + 3 Docetaxel Arm B: 3 FEC 100 + 3 Ixabepilone TNBC (ER-/PR-/HER2-) ER+/PR-/HER2-
    Number of subjects analysed
    398
    364
    586
    167
    Units: percent
        number (confidence interval 95%)
    87.0 (83.1 to 90.0)
    87.6 (83.6 to 90.6)
    0.89 (0.58 to 1.36)
    1.23 (0.52 to 2.9)
    Statistical analysis title
    		 OS analysis
    Comparison groups
    ARM A: 3 FEC 100 + 3 Docetaxel v Arm B: 3 FEC 100 + 3 Ixabepilone
    Number of subjects included in analysis
    762
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.897
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.42

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From inclusion until 30 days after end of treatment (up to 5 years).
    Adverse event reporting additional description
    For non-serious adverse events, the number of occurrences were not recorded, the number of patient affected were the only value available. Thus, the number of patient affected was entered in both "Subjects affected number" and "Occurrence all number" fields.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    ARM A
    Reporting group description
    		 All randomized subjects having received at least one dose of chemotherapy. The patients are analyzed according to the arm of treatment received in the cycle 4. If the cycle 4 has not been done, the arm for the analysis is Arm of randomization. 9 patients switched from Arm B to Arm A. Safety analyses were conducted on 757 patients.

    Reporting group title
    Arm B
    Reporting group description
    		 All randomized subjects having received at least one dose of chemotherapy. The patients are analyzed according to the arm of treatment received in the cycle 4. If the cycle 4 has not been done, the arm for the analysis is Arm of randomization. 9 patients switched from Arm B to Arm A. Safety analyses were conducted on 757 patients.

    Serious adverse events
    		 ARM A Arm B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    208 / 404 (51.49%)
    158 / 353 (44.76%)
         number of deaths (all causes)
    58
    51
         number of deaths resulting from adverse events
    0
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of the cervix
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast carcinoma
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast ductal carcinoma
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carcinoma of tongue
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chronic myeloid leukaemia
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal adenocarcinoma
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial adenocarcinoma
         subjects affected / exposed
    2 / 404 (0.50%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial carcinoma
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastric cancer
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of cardia
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melanoma
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myeloid leukemia, acute
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neuroendocrine tumour of the lung
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ovarian cancer
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian carcinoma
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreas cancer
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary carcinoma
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular disorders
    Embolism pulmonary
         subjects affected / exposed
    1 / 404 (0.25%)
    2 / 353 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jugular vein thrombosis
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphocele
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis cerebral vein
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    2 / 404 (0.50%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device implant
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extravasation
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fever
         subjects affected / exposed
    5 / 404 (1.24%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    3 / 5
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 404 (0.00%)
    3 / 353 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucositis
         subjects affected / exposed
    2 / 404 (0.50%)
    3 / 353 (0.85%)
         occurrences causally related to treatment / all
    2 / 2
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Allergic reaction
         subjects affected / exposed
    1 / 404 (0.25%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Allergy
         subjects affected / exposed
    0 / 404 (0.00%)
    3 / 353 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Device complication
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device failure
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection injection site
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis in device
         subjects affected / exposed
    0 / 404 (0.00%)
    2 / 353 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Auricular fibrillation
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac ischemia
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non ST segment elevation acute coronary syndrom
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 404 (0.25%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral hypoperfusion
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intercostal neuralgia
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 404 (0.00%)
    10 / 353 (2.83%)
         occurrences causally related to treatment / all
    0 / 0
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain nerve
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sensory neuropathy
         subjects affected / exposed
    1 / 404 (0.25%)
    4 / 353 (1.13%)
         occurrences causally related to treatment / all
    1 / 1
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 404 (0.25%)
    2 / 353 (0.57%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aplasia bone marrow
         subjects affected / exposed
    1 / 404 (0.25%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile aplasia
         subjects affected / exposed
    1 / 404 (0.25%)
    4 / 353 (1.13%)
         occurrences causally related to treatment / all
    1 / 1
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    55 / 404 (13.61%)
    27 / 353 (7.65%)
         occurrences causally related to treatment / all
    58 / 58
    30 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphocele
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    139 / 404 (34.41%)
    45 / 353 (12.75%)
         occurrences causally related to treatment / all
    251 / 251
    129 / 130
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Ear disorder
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye infection
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's enteritis
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 404 (0.00%)
    3 / 353 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epigastralgia
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction complicating hernia
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucositis oral
         subjects affected / exposed
    0 / 404 (0.00%)
    6 / 353 (1.70%)
         occurrences causally related to treatment / all
    0 / 0
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 404 (0.50%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic dysfunction
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Allergic skin reaction
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis bullous
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exfoliative dermatitis
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fingernail discoloration
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    3 / 404 (0.74%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash erythematous
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Recall phenomenon
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Swelling face
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hematuria
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection urinary tract
         subjects affected / exposed
    0 / 404 (0.00%)
    2 / 353 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Abscess soft tissue
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    0 / 404 (0.00%)
    2 / 353 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular pain
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain bone
         subjects affected / exposed
    0 / 404 (0.00%)
    1 / 353 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia with hypoxaemia
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 404 (0.00%)
    3 / 353 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    2 / 2
    Metabolism and nutrition disorders
    Hypercalcemia
         subjects affected / exposed
    1 / 404 (0.25%)
    0 / 353 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 ARM A Arm B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    404 / 404 (100.00%)
    353 / 353 (100.00%)
    Cardiac disorders
    Cardiovascular
         subjects affected / exposed
    32 / 404 (7.92%)
    33 / 353 (9.35%)
         occurrences all number
    32
    33
    Nervous system disorders
    Neurotoxicity (motor)
         subjects affected / exposed
    34 / 404 (8.42%)
    47 / 353 (13.31%)
         occurrences all number
    34
    47
    Neurotoxicity (Sensory)
         subjects affected / exposed
    100 / 404 (24.75%)
    152 / 353 (43.06%)
         occurrences all number
    100
    152
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    327 / 404 (80.94%)
    275 / 353 (77.90%)
         occurrences all number
    327
    275
    Febrile neutropenia
         subjects affected / exposed
    69 / 404 (17.08%)
    40 / 353 (11.33%)
         occurrences all number
    69
    40
    Thrombopenia
         subjects affected / exposed
    74 / 404 (18.32%)
    75 / 353 (21.25%)
         occurrences all number
    74
    75
    Edema
         subjects affected / exposed
    68 / 404 (16.83%)
    47 / 353 (13.31%)
         occurrences all number
    68
    47
    Neutropenia
         subjects affected / exposed
    330 / 404 (81.68%)
    302 / 353 (85.55%)
         occurrences all number
    330
    302
    General disorders and administration site conditions
    Fever NOS
         subjects affected / exposed
    85 / 404 (21.04%)
    59 / 353 (16.71%)
         occurrences all number
    85
    59
    Gastrointestinal disorders
    Nausea, vomiting
         subjects affected / exposed
    327 / 404 (80.94%)
    283 / 353 (80.17%)
         occurrences all number
    327
    283
    Hepatobiliary disorders
    Hepatic disorder
         subjects affected / exposed
    14 / 404 (3.47%)
    31 / 353 (8.78%)
         occurrences all number
    14
    31
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    313 / 404 (77.48%)
    289 / 353 (81.87%)
         occurrences all number
    313
    289
    Cutaneous disorder
         subjects affected / exposed
    159 / 404 (39.36%)
    101 / 353 (28.61%)
         occurrences all number
    159
    101
    Nail condition
         subjects affected / exposed
    101 / 404 (25.00%)
    61 / 353 (17.28%)
         occurrences all number
    101
    61
    Infections and infestations
    Infection
         subjects affected / exposed
    121 / 404 (29.95%)
    109 / 353 (30.88%)
         occurrences all number
    121
    109
    Mucositis
         subjects affected / exposed
    211 / 404 (52.23%)
    173 / 353 (49.01%)
         occurrences all number
    211
    173

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Sep 2007
    • Patient inform consent form modification: - now includes the possibility of data trabsfer to commercial companies - sponsor insurance contact adress update • Investigators’ list update • Protocol modification: - Serious addverse event form notification update to comply with the sponsor’ SOP - Statistical considerations based on sample size was updated to “a relative disease-free survival risk of 0.77 and a relapse risk reduction of 23%” from a relative disease-free survival risk of 0.72 and a relapse risk reduction of 28%” - Refences modification
    06 Dec 2007
    • Investigator list update
    13 May 2008
    • Ixabepilone (BMS-247550) investigator brochure update • Investigators’ list update
    18 Dec 2008
    • Protocol modification: inclusion criteria: - Inclusion criteria N°5 : the delay between surgery and the first treatment administration is increased from 42 to 49 days. - Inclusion criteria N°13: bilirubine level is decreased from 1.5 ULN to ≤ 1.0 ULN at inclusion - Inclusion criteria N°16: LVEF value is ≥50% instead of >50% • Protocol modification: dose adjustments and toxicities management: - Ixabepilone arm toxicities management clarification - Dose adjustment for ixabepilone passes from 25 to 20% reduction (passing from 30 mg/m2 to 32 mg/m2) - Docetaxel arm toxicities management clarification • Protocol modification: radiotherapy recommenadation precisions • Protocol modification: Ixabepilone preparation and administration update • Protocol modification: imaging : - Follow up: manadtory mamography on a yearly basis - Baseline evaluation: X-ray of the chest, liver imaging and bone scintigraphy need to be done within 3 months ahead of randomization • Investigators’ list update • New investigator brochure • Administrative changes : - Contacts list update - Randomizationprocess update - Local requirement update with regard to specific protocol sections - Patient inform consent form is no longer included in the protocol
    11 Jun 2009
    • Investigators’ list update
    06 Jan 2010
    • Investigators’ list update
    08 Apr 2010
    • Investigators’ list update
    30 Jun 2010
    • Protocol modification: - Toxicities management clarification - G-CSF use clarification - Modification of biological follow-up assessments during chemotherapy - Flowchart of investigations and study drug administration update - Hormonaux therapy recommendation updates - Treatment replacement after investigational study treatment discontinuation • Modification of trial duration: Inclusion period extended from 3 to 6 years • Change in docetaxel (taxotere®) pharmaceutical form • Modification of the patients inform consent form - Clarification regrading trial’s ojectives and expected benefits - Clarification of docetaxel (taxotere®) expected toxicities - Follow-up schedule • Investigators’ list update • Administrative change: contact list update
    21 Jul 2010
    • Investigators’ list update
    16 Nov 2010
    • Investigators’ list update
    14 Dec 2010
    • Legal and administratives changes related to the transfer of research activities from FNCLCC to Unicancer.
    13 Jan 2012
    • Investigators’ list update

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    09 Sep 2010
    Overall, 762 patients were included despite a planned number of 2500 due to the study premature termination on 09-SEP-2010 (all inclusions stopped the same day, The Ethic Committees and Competent Authorities were also informed). This early termination resulted from Bristol-Myers Squibb (BMS) announcement to withdraw its financial support to the PACS08 study as BMS decided to stop the worldwide development of ixabepilone. This information was received by the Steering committee on 21-JUL-2010. An extraordinary steering committee meeting was held on 09-SEP-2010 and concluded that trial was to be stopped and all inclusion terminated mostly as ixabepilone would no longer be made available to the sponsor. Due to regulatory considerations, and taking into account that ixabepilone is not marketed in Europe, the steering recommended: • To switch ixabepilone assigned patients who had not begun the sequence of treatment to the reference arm, • To switch patients who have already received one or two cycles of ixabepilone to the reference arm 3 FEC100 + 3 docetaxel as it is recommended for patients withdrawn for acute toxicities under ixabepilone treatment. • All patients included were to be followed according to the protocol
    -

    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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