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    Clinical Trial Results:
    A Randomized Multicenter Phase II Study Identifying Hormonosensivity Profiles and Evaluating the Efficacy of Anastrozole and Fulvestrant in the Neoadjuvant Treatment of Operable Breast Cancer in Postmenopausal Women.

    Summary
    EudraCT number
    		 2006-006409-10
    Trial protocol
    		 FR  
    Global end of trial date
    28 Oct 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jul 2023
    First version publication date
    06 Jul 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CARMINA 02/0609
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00629616
    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
    01 Jun 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of anastrozole and fulvestrant in term of clinical response rates (complete and partial responses) at 6 months in postmenopausal women with operable hormone receptor positive stage T2 to T4 breast carcinoma.
    Protection of trial subjects
    In order to ensure the protection of the rights, safety and well-being of trial subjects, this clinical trial was conducted in accordance with the Declaration of Helsinki (1964) and subsequent amendments, ICH Good Clinical Practice Guidelines (CPMP/ICH/135/95), the European Directive (2001/20/CE) and the applicable local regulatory requirements and laws. Furthermore, independent Ethics Committees reviewed and gave favorable opinions to the study documents, including the initial protocol and all subsequent amendments, and all information and documents provided to subjects/patients. Written informed consent was obtained from all patients prior to enrollment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Oct 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 116
    Worldwide total number of subjects
    116
    EEA total number of subjects
    116
    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)
    31
    From 65 to 84 years
    75
    85 years and over
    10

    Subject disposition

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    Recruitment
    Recruitment details
    		 From 02-OCT-2007 to 14-APR-2011, 116 eligible patients who had signed the study informed consent form were randomized. Thus, 59 and 57 patients were allocated to the anastrozole and fulvestrant arms, respectively. Two patients within the anastrozole arm were found, early on, in violation of the non-inclusion criteria and thereby excluded.

    Pre-assignment
    Screening details
    		 The trial consisted of a screening phase before randomization to establish eligibility, a treatment phase (4 months). Upon completion (day 120), a progress assessment was to be conducted. The treatments were to be or not extended for 2 additional months. A long-term follow-up to monitor the relapse-free, event-free and overall survivals, and safety

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Anastrozole
    Arm description
    		 Patients allocated to this Arm were to receive anastrozole for 4 months. Upon completion (day 120), a progress assessment was to be conducted. In case of clinical progression or clinical response rate strictly below 30%, Anastrozole treatment was to be stopped and the patient scheduled for surgery. Otherwise, anastrozole was to be administered for an additional period of two months (up to day 180).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Anastrozole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg per day of anastrozole was to be orally administered for 120 days. Upon completion (day 120), assuming the progress assessment showed an absence of clinical progression or a clinical response rate ≥ 30%, anastrozole treatment regimen was to be prolonged for 60 days (up to day 180), otherwise the treatment was to be terminated and a pre-surgery assessment conducted.

    Arm title
    		 Fulvestrant
    Arm description
    		 Patients allocated to this Arm were to receive fulvestrant every two weeks for the first month then every 4 weeks for the next 3 months. Upon completion (day 120), a progress assessment was to be conducted. In case of clinical progression or clinical response rate strictly below 30%, fulvestrant treatment was to be stopped and the patient scheduled for surgery. Otherwise, fulvestrant was to be administered for an additional period of two months (up to day 180).
    Arm type
    		 Reference product

    Investigational medicinal product name
    Fulvestrant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    500 mg of fulvestrant was to be administered once every 15 days (D1, D15 and D29) in 2 slow (over 1 to 2 minutes) intramuscular buttocks shots (250 mg in each gluteal area) for 30 days then once every 28 days according to the same procedure for 90 more days. Upon completion (day 120), assuming the progress assessment showed an absence of clinical progression or a clinical response rate ≥ 30%, 500 mg of fulvestrant was to be administered once every 28 days for 60 more days (up to day 180), otherwise the treatment was to be terminated and a pre-surgery assessment conducted.

    Number of subjects in period 1
    		Anastrozole Fulvestrant
    Started
    59
    57
    Completed
    55
    52
    Not completed
    4
    5
         Bilateral tumor
    -
    1
         Disease progression
    2
    2
         Investigator decision
    2
    1
         Patient choice
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Anastrozole
    Reporting group description
    		 Patients allocated to this Arm were to receive anastrozole for 4 months. Upon completion (day 120), a progress assessment was to be conducted. In case of clinical progression or clinical response rate strictly below 30%, Anastrozole treatment was to be stopped and the patient scheduled for surgery. Otherwise, anastrozole was to be administered for an additional period of two months (up to day 180).

    Reporting group title
    Fulvestrant
    Reporting group description
    		 Patients allocated to this Arm were to receive fulvestrant every two weeks for the first month then every 4 weeks for the next 3 months. Upon completion (day 120), a progress assessment was to be conducted. In case of clinical progression or clinical response rate strictly below 30%, fulvestrant treatment was to be stopped and the patient scheduled for surgery. Otherwise, fulvestrant was to be administered for an additional period of two months (up to day 180).

    Reporting group values
    		 Anastrozole Fulvestrant Total
    Number of subjects
    		 59 57 116
    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)
    		 20 12 32
        From 65-84 years
    		 35 39 74
        85 years and over
    		 4 6 10
    Age continuous
    Units: years
        median (full range (min-max))
    		 68 (53 to 92) 74 (51 to 88) -
    Gender categorical
    Units: Subjects
        Female
    		 59 57 116
        Male
    		 0 0 0
    ECOG performance status
    Units: Subjects
        ECOG 0
    		 49 50 99
        ECOG 1
    		 10 7 17
    Menopausal under hormone replacement therapy
    Units: Subjects
        yes
    		 21 19 40
        no
    		 38 38 76
    Tumor location
    Units: Subjects
        Right breast
    		 32 30 62
        Left breast
    		 27 27 54
    Age <60 without hysterectomy and amenorrhea since at least 12 months, n/N (%)
    Units: Subjects
        yes
    		 4 7 11
        no
    		 55 50 105
    Age <60 with hysterectomy history & FSH >30 UI/L, n/N (%)
    Units: Subjects
        yes
    		 0 1 1
        no
    		 59 56 115
    Menopausal under hormone replacement therapy, n/N (%)
    Units: Subjects
        yes
    		 21 19 40
        no
    		 38 38 76
    Weigh
    Units: kilogram(s)
        median (full range (min-max))
    		 65 (45 to 114) 67 (50 to 91) -
    Menopausal age
    Units: year
        median (full range (min-max))
    		 50 (40 to 58) 50 (39 to 60) -
    Tumor size
    Units: millimetre(s)
        median (inter-quartile range (Q1-Q3))
    		 40 (35 to 50) 40 (35 to 50) -
    Tumor size
    Units: millimetre(s)
        median (full range (min-max))
    		 40 (20 to 75) 40 (28 to 80) -
    Height
    Units: centimetre
        median (full range (min-max))
    		 160 (150 to 170) 159 (145 to 175) -

    End points

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    End points reporting groups
    Reporting group title
    Anastrozole
    Reporting group description
    		 Patients allocated to this Arm were to receive anastrozole for 4 months. Upon completion (day 120), a progress assessment was to be conducted. In case of clinical progression or clinical response rate strictly below 30%, Anastrozole treatment was to be stopped and the patient scheduled for surgery. Otherwise, anastrozole was to be administered for an additional period of two months (up to day 180).

    Reporting group title
    Fulvestrant
    Reporting group description
    		 Patients allocated to this Arm were to receive fulvestrant every two weeks for the first month then every 4 weeks for the next 3 months. Upon completion (day 120), a progress assessment was to be conducted. In case of clinical progression or clinical response rate strictly below 30%, fulvestrant treatment was to be stopped and the patient scheduled for surgery. Otherwise, fulvestrant was to be administered for an additional period of two months (up to day 180).

    Primary: Clinical response at 6 months

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    End point title
    		 Clinical response at 6 months [1]
    End point description
    The primary endpoint aimed to measure the efficacy of anastrozole vs. fulvestrant in term of clinical response rates (complete and partial responses according to RECIST v1.1 criteria) after 6 months assuming the 4 months assessment demonstrated either a stable disease or a sufficient clinical response. Note: CR: complete response; PR: partial response
    End point type
    Primary
    End point timeframe
    6 months after randomisation.
    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: The primary efficacy endpoint aimed to evaluate the clinical response to treatment at 6 months in each arm, the observed response rates (complete or partial response 30%) was to be presented for each arm together with their 95% confidence interval. No direct comparison between the two arms was to be performed.
    End point values
    		 Anastrozole Fulvestrant
    Number of subjects analysed
    57
    57
    Units: percent of patients
    number (not applicable)
        Responders (CR,PR)
    52.6
    36.8
        Non-Responders
    47.4
    63.2
    No statistical analyses for this end point

    Secondary: Evaluation of the breast conservation rate

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    End point title
    		 Evaluation of the breast conservation rate
    End point description
    The secondary efficacy objective was to evaluate the breast conservation rate in each arm, percentages of patients having benefited of conservative breast surgery will be calculated for each of the two treatment groups. Note: As one Arm B’s patient was operated outside of her assigned investigating center, no surgery details were available. Thereby this patient was not included in the breast conservation rate analysis (i.e., the Arm B population analyzed was 56 not 57).
    End point type
    Secondary
    End point timeframe
    Percentages of patients having benefited of conservative breast surgery will be calculated for each of the two treatment groups.
    End point values
    		 Anastrozole Fulvestrant
    Number of subjects analysed
    59
    56 [2]
    Units: percent of patients
    number (not applicable)
        Conservative surgery
    57.6
    50.0
    Notes
    [2] - the Arm B population analyzed was 56 not 57
    No statistical analyses for this end point

    Secondary: Evaluation of the tumoral histological response

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    End point title
    		 Evaluation of the tumoral histological response
    End point description
    The evaluation of the tumoral histological response was based on Sataloff classification. The histological response rate according to Sataloff classification was not different between the two arms (p=0.79).
    End point type
    Secondary
    End point timeframe
    At time of surgery
    End point values
    		 Anastrozole Fulvestrant
    Number of subjects analysed
    56
    56
    Units: percent of patients
    number (not applicable)
        Pathological responses
    17.8
    14.3
    No statistical analyses for this end point

    Secondary: Evolution of the tumor clinical size per arm

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    End point title
    		 Evolution of the tumor clinical size per arm
    End point description
    Evolution of the tumor clinical size per arm after 6 months of treatment compared to baseline.
    End point type
    Secondary
    End point timeframe
    After 6 months of treatment.
    End point values
    		 Anastrozole Fulvestrant
    Number of subjects analysed
    59
    57
    Units: millimetre(s)
    median (full range (min-max))
        Baseline
    40 (20 to 75)
    40 (28 to 80)
        6 months
    20 (0 to 40)
    28 (0 to 50)
    No statistical analyses for this end point

    Secondary: Changes un Ki67 expression over time

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    End point title
    		 Changes un Ki67 expression over time
    End point description
    End point type
    Secondary
    End point timeframe
    at time of surgery
    End point values
    		 Anastrozole Fulvestrant
    Number of subjects analysed
    59
    57
    Units: percent
    arithmetic mean (standard deviation)
        arithmetic mean (confidence interval 95%)
    -5.1 ± 9.1
    -4.6 ± 9.9
    Statistical analysis title
    		 Efficacy result
    Comparison groups
    Fulvestrant v Anastrozole
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0007
    Method
    		 paired Student t-test)
    Confidence interval

    Secondary: Overall survival at 3 years

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    End point title
    		 Overall survival at 3 years
    End point description
    Overall survival was defined as the number of patients being alive at least 36 months after randomization.
    End point type
    Secondary
    End point timeframe
    36 months after randomization.
    End point values
    		 Anastrozole Fulvestrant
    Number of subjects analysed
    59
    57
    Units: Percent of patients
    median (confidence interval 95%)
        Overall survival at 3 years
    100 (100 to 100)
    98.2 (94.9 to 100)
    Statistical analysis title
    		 Efficacy result
    Comparison groups
    Anastrozole v Fulvestrant
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Logrank
    Confidence interval
    Dispersion value
    0.868

    Secondary: Relapse-free survival at 3 years

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    End point title
    		 Relapse-free survival at 3 years
    End point description
    The relapse-free survival was defined as the time interval between the patient inclusion date and the date of relapse occurrence.
    End point type
    Secondary
    End point timeframe
    3 years post-treatment.
    End point values
    		 Anastrozole Fulvestrant
    Number of subjects analysed
    59
    57
    Units: percent of patients
    median (confidence interval 95%)
        Relapse-free survival
    94.9 (89.4 to 100)
    91.2 (84.1 to 98.9)
    Statistical analysis title
    		 Efficacy result
    Comparison groups
    Anastrozole v Fulvestrant
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Logrank
    Confidence interval
    Dispersion value
    0.29

    Secondary: Event-free survival (EFS) at 3 years

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    End point title
    		 Event-free survival (EFS) at 3 years
    End point description
    The event-free survival is defined as the time interval between the patient inclusion date and the date of event occurrence, up to 3 years.
    End point type
    Secondary
    End point timeframe
    3 years post-treatment.
    End point values
    		 Anastrozole Fulvestrant
    Number of subjects analysed
    59
    57
    Units: percent of patients
    median (confidence interval 95%)
        Event-free survival (EFS)
    90.9 (83.5 to 98.9)
    87.6 (79.4 to 96.6)
    Statistical analysis title
    		 Efficacy result
    Comparison groups
    Anastrozole v Fulvestrant
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Logrank
    Confidence interval
    Dispersion value
    0.35

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From inclusion until 30 days after end of treatment.
    Adverse event reporting additional description
    Toxicity was to be evaluated according to the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0) established by the National Cancer Institute (NCI).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    8
    Reporting groups
    Reporting group title
    Anastrozole
    Reporting group description
    		 -

    Reporting group title
    Fulvestrant
    Reporting group description
    		 -

    Serious adverse events
    		 Anastrozole Fulvestrant
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 59 (10.17%)
    5 / 57 (8.77%)
         number of deaths (all causes)
    2
    2
         number of deaths resulting from adverse events
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epidermoid carcinoma
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gliosarcoma
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 57 (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
    1 / 59 (1.69%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 57 (3.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Surgical and medical procedures
    Basal cell carcinoma excision
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 57 (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
    		 Anastrozole Fulvestrant
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    59 / 59 (100.00%)
    57 / 57 (100.00%)
    Investigations
    Increased liver enzyme levels
    Additional description: The occurrences are not available
         subjects affected / exposed
    59 / 59 (100.00%)
    57 / 57 (100.00%)
         occurrences all number
    59
    57
    Vascular disorders
    Venous thromboembolism
    Additional description: The occurrences are not available
         subjects affected / exposed
    59 / 59 (100.00%)
    57 / 57 (100.00%)
         occurrences all number
    59
    57
    Nervous system disorders
    Headache
    Additional description: The occurrences are not available
         subjects affected / exposed
    59 / 59 (100.00%)
    57 / 57 (100.00%)
         occurrences all number
    59
    57
    General disorders and administration site conditions
    Hot flush
    Additional description: The occurrences are not available
         subjects affected / exposed
    59 / 59 (100.00%)
    57 / 57 (100.00%)
         occurrences all number
    59
    57
    Asthenia
    Additional description: The occurrences are not available
         subjects affected / exposed
    59 / 59 (100.00%)
    57 / 57 (100.00%)
         occurrences all number
    59
    57
    Injection site reaction
    Additional description: The occurrences are not available
         subjects affected / exposed
    59 / 59 (100.00%)
    57 / 57 (100.00%)
         occurrences all number
    59
    57
    Gastrointestinal disorders
    Nausea
    Additional description: The occurrences are not available
         subjects affected / exposed
    59 / 59 (100.00%)
    57 / 57 (100.00%)
         occurrences all number
    59
    57
    Vomiting
    Additional description: The occurrences are not available
         subjects affected / exposed
    59 / 59 (100.00%)
    57 / 57 (100.00%)
         occurrences all number
    59
    57
    Diarrhoea
    Additional description: The occurrences are not available
         subjects affected / exposed
    59 / 59 (100.00%)
    57 / 57 (100.00%)
         occurrences all number
    59
    57
    Reproductive system and breast disorders
    Vaginal dryness
    Additional description: The occurrences are not available
         subjects affected / exposed
    59 / 59 (100.00%)
    57 / 57 (100.00%)
         occurrences all number
    59
    57
    vaginal bleeding
    Additional description: The occurrences are not available
         subjects affected / exposed
    59 / 59 (100.00%)
    57 / 57 (100.00%)
         occurrences all number
    59
    57
    Skin and subcutaneous tissue disorders
    Skin rash
    Additional description: The occurrences are not available
         subjects affected / exposed
    59 / 59 (100.00%)
    57 / 57 (100.00%)
         occurrences all number
    59
    57
    Musculoskeletal and connective tissue disorders
    Muscle pain
    Additional description: The occurrences are not available
         subjects affected / exposed
    59 / 59 (100.00%)
    57 / 57 (100.00%)
         occurrences all number
    59
    57
    Joint pain
    Additional description: The occurrences are not available
         subjects affected / exposed
    59 / 59 (100.00%)
    57 / 57 (100.00%)
         occurrences all number
    59
    57
    Joint stiffness
    Additional description: The occurrences are not available
         subjects affected / exposed
    58 / 59 (98.31%)
    57 / 57 (100.00%)
         occurrences all number
    58
    57
    Infections and infestations
    Urinary tract infection
    Additional description: The occurrences are not available
         subjects affected / exposed
    59 / 59 (100.00%)
    57 / 57 (100.00%)
         occurrences all number
    59
    57

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jun 2008
    -Protocol updates: o Modification of the Inclusion criteria #5: The number of required frozen biopsie samples before treatment inititiation updated from 1 to 2. o The type of surgery recommended after treatment was updated, TCSP was replaced by TCA (Lumpectomie with axillary node dissection) and MCSP by MCA (Mastectomy with axillary node dissection). o The efficacy criterion for partial or complete observed response rates assed by RECIST at 4 and 6 months was updated from strictly superior to 30% to superior or equal to 30%. o IRM and PET scan exams scheduled at the 4 months follow-up were restricted to the patients presenting with an insufficient clinical response (i.e., strictly below 30%). -Investigator brochure updates: FASLODEX™ (ZD9238; Fulvestrant) and ARIMIDEX™ (ZD1033; Anastrozole) brochures were updated. -Compliance update: the serious adverse event notification form was updated to comply with new FNCLCC and BECT Standard Operating Procedures. -Insurance broker contact update: the address of BiomedicInsure was updated. -Investigators’ list update: Dr. Florence LEREBOURS replaced Dr Michèle TUBIANA-HULIN as coordinating investigator. -Dr. Véronique BECETTE joined the protocol drafting committee.
    07 Oct 2009
    -Protocol update: the inclusion period and global length of the trial were extended from 2 to 4 years and rom 5.5 to 7.5 years, respectively. -Study design update: optional PET scan exams wrongly scheduled every 6 months post-surgery were removed from the study design. -Administrative structure updates: o Sponsor scientific board update: Dr Jocelyne BERILLE replaced Dr. Jean GENEVE as FNCLCC’s scientific director. o Study coordination: Pauline PIRES (Project Leader) teamed-up with Anne-Laure MARTIN (Project Leader) to support the study coordination.
    07 Oct 2009
    -Protocol update: modification of inclusion criteria #2: tumor size T2 updated from ≥3 cm to > 2 cm) -Investigator brochure update: FASLODEX™ (ZD9238; Fulvestrant) brochures was updated. -Investigators’ list update. -Study coordination: Pauline PIRES (Project Leader) was replaced by Dr. Jérôme LEMONNIER.
    13 Sep 2011
    -Administrative structure updates: o Sponsor coordinators contact update: - j-berille@fnclcc.fr was updated to j-berille@unicancer.fr - al-martin@fnclcc.fr was updated to al-martin@unicancer.fr - j-lemonnier@fnclcc.fr was updated to j-lemonnier@unicancer.fr o Sponsor administrative update: Anne-Laure MARTIN (former Group Leader) was promoted Operational Associate Director. o Coordinating Investigator contact update: - f.lerebours@steloud-huguenin.org was updated to florence.lerebours@curie.net o Statistician contact update: - e.fourme@steloud-huquenin.org was updated to emmanuelle.fourme@curie.net -Investigator brochure updates: FASLODEX™ (ZD9238; Fulvestrant) and ARIMIDEX™ (ZD1033; Anastrozole) brochures were updated.
    26 Jan 2012
    -Administrative structure updates: o Sponsor identification update: on both the Protocol and the Informed Consent Form, the FNCLCC and BET logos and acronyms were replaced by UNICANCER and R&D UNICANCER, respectively. The logo of the UNICANCER BREAST GROUP was also added on those documents. o Sponsor contact updates: Bureau d'Etudes Cliniques et Thérapeutiques Pharmacovigilance (email pv-bect@fnclcc.fr) was replaced by R&D UNICANCER Pharmacovigilance (email pvrd@unicancer.fr). However phone and fax N° were kept unchanged. -Protocol identification update: CARMINA 02/0609 was replaced by UC-0104/0609 CARMINA02 on both the Protocol and the Informed Consent Form. -Protocol flow alteration: o Former annexes 2, 3 & 7 were removed, o ECOG performance status described in annexe 4 was incorporated in a new annexe 2, o Toxicity evaluation details were moved from annexe 8 to 5, o Molecular characteristics described in annexe 9 were moved to annexe 6, o IRM-based teatment evaluation was moved from annexe 10 to 9, o PET scan-based teatment evaluation was moved from annexe 11 to 8, o The expected/unexpected nature of the event associated with each of the investigational products were moved from annexe 6 to 4. o The Inform Consent Form and associated guidelines were no longer incorporated within annexe 2 and 3. -Sponsor Insurance: A new proof of insurance was provided.
    06 Dec 2012
    -Administrative structure updates: o Coordinating Investigator contact update: Dr. Florence LEREBOURS address was updated from “Centre René Huguenin” to “Institut CURIE - Hôpital René Huguenin”. o Statistician contact update: Dr. Emmanuelle FOURME address was updated from “Centre René Huguenin” to “Institut CURIE - Hôpital René Huguenin”. o Sponsor administrative updates: - Anne-Laure MARTIN (former Operational Associate Director) was promoted Director of Clinical and Translational Research. - Dr. Jocelyne BERILLE retired from the Scientific Director position. o Sponsor coordination contact update: information requests regarding study coordination were to be addressed to Dr. Jérôme LEMONNIER instead of Anne-Laure MARTIN. -Protocol update: all exploratory objectives involving functional IRM and PET scan imaging was now to be centralized for review and analysis at the Institut CURIE - Hôpital René Huguenin.
    03 Dec 2013
    -Investigators’ list update.

    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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