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    Clinical Trial Results:
    Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for Locally Recurrent Breast Cancer (CALOR).

    Summary
    EudraCT number
    		 2005-001484-64
    Trial protocol
    		 BE  
    Global end of trial date
    22 Aug 2016

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

    Trial information

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    Trial identification
    Sponsor protocol code
    IBCSG 27-02 CALOR
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00074152
    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 313899391, regulatoryoffice@ibcsg.org
    Scientific contact
    IBCSG Coordinating Center, International Breast Cancer Study Group (IBCSG), +41 313899391, 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
    Final
    Date of interim/final analysis
    08 Sep 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this long-term follow-up update is to evaluate the efficacy of adjuvant chemotherapy after local treatment of a first loco-regional recurrence of breast cancer at a median follow-up of nine years, including analyses according to ER status of the ILRR, recognizing that the ERpositive subgroup in particular requires longer follow-up than previously available.
    Protection of trial subjects
    Participating institutions’ ethics committees or Institutional Review Boards approved the trial according to local laws and regulations. All patients gave written informed consent, and the trial was performed in compliance with the Helsinki Declaration. The Data and Safety Monitoring Committee reviewed accrual and safety data semi-annually throughout the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Aug 2003
    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
    Hungary: 33
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Switzerland: 16
    Country: Number of subjects enrolled
    Spain: 20
    Country: Number of subjects enrolled
    United States: 42
    Country: Number of subjects enrolled
    South Africa: 5
    Country: Number of subjects enrolled
    Peru: 1
    Country: Number of subjects enrolled
    Netherlands: 12
    Country: Number of subjects enrolled
    Canada: 31
    Worldwide total number of subjects
    162
    EEA total number of subjects
    65
    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)
    131
    From 65 to 84 years
    31
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 IBCSG and GEICAM (Spain) began enrolling in collaboration with Breast International Group (BIG) in 2003, and NSABP (US/Canada) began in 2005, and BOOG (Netherlands) in 2006 (through BIG). BIG centers enrolled 89 patients, and NSABP enrolled 73. There were 55 centers from nine countries participating in the trial.

    Pre-assignment
    Screening details
    		 This trial used a web-based randomization system. Each Participating Group determined how its Participating Centers will access the randomization system, either through a Group Randomization Center, or directly from the Participating Center.

    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 I
    Arm description
    		 Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery. Radiation therapy: Given within 6 months after surger
    Arm type
    		 Observation

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Arm II
    Arm description
    		 Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. Chemotherapy: Given within 10 weeks after surgery.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Chemotherapy
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    If the patient was randomized to receive chemotherapy, choice of chemotherapy, dose adjustments, and supportive therapies was left to the discretion of the investigators. The protocol recommended at least two cytotoxic drugs for three to six months. Chemotherapy was to start within four weeks of randomization and within 16 weeks of resection of locoregional recurrence.

    Number of subjects in period 1
    		Arm I Arm II
    Started
    77
    85
    Completed
    22
    52
    Not completed
    55
    33
         Death
    21
    9
         Lack of efficacy
    34
    24

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm I
    Reporting group description
    		 Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery. Radiation therapy: Given within 6 months after surger

    Reporting group title
    Arm II
    Reporting group description
    		 Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. Chemotherapy: Given within 10 weeks after surgery.

    Reporting group values
    		 Arm I Arm II Total
    Number of subjects
    		 77 85 162
    Age categorical
    Units: Subjects
        <=18
    		 0 0 0
        18 - 65
    		 60 71 131
        >=65
    		 17 14 31
    Gender categorical
    Units: Subjects
        Female
    		 77 85 162
        Male
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        United States
    		 19 23 42
        Hungary
    		 17 16 33
        Canada
    		 15 16 31
        Spain
    		 9 11 20
        Peru
    		 1 0 1
        Australia
    		 1 1 2
        South Africa
    		 3 2 5
        Netherlands
    		 6 6 12
        Switzerland
    		 6 10 16
    Surgery for primary tumor
    Units: Subjects
        Mastectomy
    		 31 33 64
        Breast conserving
    		 46 52 98
    Estrogen receptor (ER) status of the isolated local or regional recurrence
    Units: Subjects
        Positive
    		 48 56 104
        Negative
    		 29 29 58
    Progesterone receptor (PgR) status of the isolated local or regional recurrence
    Units: Subjects
        Positive
    		 35 44 79
        Negative
    		 40 39 79
        Not available
    		 2 2 4
    Location of isolated loco-regional recurrence
    Units: Subjects
        Breast
    		 41 47 88
        Mx scar/chest wall
    		 26 27 53
        Regional lymph nodes
    		 10 11 21
    Menopausal Status at isolated loco-regional recurrence
    Units: Subjects
        pre
    		 14 20 34
        post
    		 63 65 128
    Estrogen receptor (ER) status of primary tumor
    Units: Subjects
        negative
    		 20 27 47
        positive
    		 47 49 96
        unknown
    		 10 9 19
    Time from primary surgery to isolated loco-regional recurrence (ILRR) surgery
    Units: Years
        median (full range (min-max))
    		 6.2 (2.9 to 11.3) 5.0 (2.9 to 9.5) -

    End points

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    End points reporting groups
    Reporting group title
    Arm I
    Reporting group description
    		 Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery. Radiation therapy: Given within 6 months after surger

    Reporting group title
    Arm II
    Reporting group description
    		 Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. Chemotherapy: Given within 10 weeks after surgery.

    Primary: Disease-free Survival

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    End point title
    		 Disease-free Survival
    End point description
    End point type
    Primary
    End point timeframe
    5 years after randomization
    End point values
    		 Arm I Arm II
    Number of subjects analysed
    77
    85
    Units: Percentage of participants
        number (confidence interval 95%)
    57 (44 to 67)
    69 (56 to 79)
    Statistical analysis title
    		 Statistical analysis primary endpoint
    Comparison groups
    Arm I v Arm II
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.083
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 1.06

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    End point type
    Secondary
    End point timeframe
    5 years after randomization
    End point values
    		 Arm I Arm II
    Number of subjects analysed
    77
    85
    Units: Percentage of participants
        number (confidence interval 95%)
    76 (63 to 85)
    88 (77 to 94)
    No statistical analyses for this end point

    Secondary: Sites of First Failures

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    End point title
    		 Sites of First Failures
    End point description
    Tumor recurrence in the breast, lymph nodes or other areas of the body including bone, lung, liver, central nervous system, bone marrow.
    End point type
    Secondary
    End point timeframe
    5 years after randomization
    End point values
    		 Arm I Arm II
    Number of subjects analysed
    77
    85
    Units: Participants
    number (not applicable)
        Failures
    34
    24
        Deaths
    21
    9
        Local or Regional
    9
    6
        Distant
    22
    15
        Soft Tissue
    2
    0
        Bone
    5
    8
        Viscera
    15
    7
        Contralateral Breast
    1
    1
        Second (non-breat) Malignancy
    0
    1
        Death without prior Cancer Event
    0
    1
        Death, cause unknown
    2
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    Arm I
    Reporting group description
    		 Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery. Radiation therapy: Given within 6 months after surgery

    Reporting group title
    Arm II
    Reporting group description
    		 Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. Chemotherapy: Given within 10 weeks after surgery.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: AEs were not an endpoint of the CALOR trial. Because the chemotherapy regimens were not consistent, and the no chemotherapy group was considered at no risk for toxicities, the CALOR trial did not collect AEs in the form of a routine checklist. Serious Adverse Events (SAEs) were collected on an event-driven basis in accordance with regulatory requirements.
    Serious adverse events
    		 Arm I Arm II
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 77 (0.00%)
    12 / 85 (14.12%)
         number of deaths (all causes)
    27
    18
         number of deaths resulting from adverse events
    Cardiac disorders
    Left ventricular dysfunction
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac ischemia
         subjects affected / exposed
    0 / 77 (0.00%)
    2 / 85 (2.35%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Motor neuropathy
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal pain
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Endometrial mucosa thickening
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Febrile neutropenia
         subjects affected / exposed
    0 / 77 (0.00%)
    3 / 85 (3.53%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary/upper respiratory infection
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm I Arm II
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 85 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Dec 2004
    To allow the use of adjuvant trastuzumab if declared prior to randomization, clarify the use of radiation therapy, and add NSABP as a collaborating group.
    18 Dec 2006
    18 December 2006. To facilitate patient accrual by broadening inclusion criteria and treatment requirements regarding timing and type of surgery and radiotherapy timing and dose.
    13 Nov 2008
    To revise the sample size to 265 patients and allow the use of lapatinib and other HER2-directed therapies. Remove quality-of-life assessments.

    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
    For support, Contact us.
    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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