Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Phase II Trial With Autologous Dendritic Cell Vaccination in Patients With Stage II-III HER2 Negative Breast Cancer

    Summary
    EudraCT number
    		 2009-017402-36
    Trial protocol
    		 ES  
    Global end of trial date
    02 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DEND/CM
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01431196
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Clinica Universidad de Navarra
    Sponsor organisation address
    AVENIDA PÍO XII, Nº 36, PAMPLONA/IRUÑA, Spain, 31008
    Public contact
    UCEC, Clinica Universidad de Navarra, 34 948 255 400, ucicec@unav.es
    Scientific contact
    UCEC, Clinica Universidad de Navarra, 34 948 255 400, ucicec@unav.es
    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
    12 Aug 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Aug 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Pathologic complete response (pCR) in the breast and the axilla.
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Feb 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 21
    Worldwide total number of subjects
    21
    EEA total number of subjects
    21
    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)
    21
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 22 patiens, 18 years and older

    Pre-assignment
    Screening details
    		 22 patients were included of which 21 completed the study. One patient, once recruited, did not continue in the study by her own decision.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Autologous dendritic cell
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    The main variable, pathological response of the tumor to chemotherapy, will be calculated after surgery after having received neoadjuvant chemotherapy and at least 4 doses of vaccines. The dosis is 5-10 x 10E6 units.

    Number of subjects in period 1
    		Treatment
    Started
    21
    Completed
    21

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 21 21
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 21 21
    Gender categorical
    Units: Subjects
        Female
    		 21 21

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 -

    Primary: Pathological Complete Response

    		 Close Top of page
    End point title
    		 Pathological Complete Response [1]
    End point description
    End point type
    Primary
    End point timeframe
    Three years from the last vaccine received during the trial.
    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: It is primarily a descriptive statistic.
    End point values
    		 Treatment
    Number of subjects analysed
    21
    Units: Number of patients
    6
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    During the treatment and follow-up of patients
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Experimental group
    Reporting group description
    		 -

    Serious adverse events
    		 Experimental group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 21 (4.76%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Experimental group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 21 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    2
    Hot flush
         subjects affected / exposed
    5 / 21 (23.81%)
         occurrences all number
    5
    Hypotension
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Thrombophlebitis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Phlebitis
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Dependent rubor
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Pallor
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    21 / 21 (100.00%)
         occurrences all number
    35
    Swelling
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    8 / 21 (38.10%)
         occurrences all number
    10
    Mucosal inflammation
         subjects affected / exposed
    20 / 21 (95.24%)
         occurrences all number
    36
    Oedema
         subjects affected / exposed
    15 / 21 (71.43%)
         occurrences all number
    20
    Temperature regulation disorder
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Vulvovaginal dryness
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    11 / 21 (52.38%)
         occurrences all number
    14
    Catarrh
         subjects affected / exposed
    9 / 21 (42.86%)
         occurrences all number
    9
    Epistaxis
         subjects affected / exposed
    3 / 21 (14.29%)
         occurrences all number
    3
    Pharyngitis
         subjects affected / exposed
    3 / 21 (14.29%)
         occurrences all number
    4
    Rhinitis
         subjects affected / exposed
    4 / 21 (19.05%)
         occurrences all number
    5
    Rhinorrhoea
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Psychiatric disorders
    Feeling of despair
         subjects affected / exposed
    4 / 21 (19.05%)
         occurrences all number
    4
    Affect lability
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Depression
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Nervous system disorders
    Insomnia
         subjects affected / exposed
    8 / 21 (38.10%)
         occurrences all number
    8
    Headache
         subjects affected / exposed
    11 / 21 (52.38%)
         occurrences all number
    13
    Anxiety
         subjects affected / exposed
    3 / 21 (14.29%)
         occurrences all number
    3
    Dizziness
         subjects affected / exposed
    5 / 21 (23.81%)
         occurrences all number
    5
    Neuropathy peripheral
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Peripheral sensory neuropathy
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    3
    Parosmia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Sciatica
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Neurological decompensation
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Paraesthesia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    12 / 21 (57.14%)
         occurrences all number
    17
    Lymphopenia
         subjects affected / exposed
    11 / 21 (52.38%)
         occurrences all number
    14
    Thrombocytopenia
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Neutropenia
         subjects affected / exposed
    3 / 21 (14.29%)
         occurrences all number
    4
    Leukopenia
         subjects affected / exposed
    6 / 21 (28.57%)
         occurrences all number
    8
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Ear infection
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    5 / 21 (23.81%)
         occurrences all number
    6
    Visual acuity reduced
         subjects affected / exposed
    3 / 21 (14.29%)
         occurrences all number
    3
    Visual impairment
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Abnormal sensation in eye
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Vision blurred
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Blepharitis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Blindness
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Gastrointestinal disorders
    Dysgeusia
         subjects affected / exposed
    8 / 21 (38.10%)
         occurrences all number
    11
    Nausea
         subjects affected / exposed
    20 / 21 (95.24%)
         occurrences all number
    23
    Constipation
         subjects affected / exposed
    13 / 21 (61.90%)
         occurrences all number
    18
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    7 / 21 (33.33%)
         occurrences all number
    10
    Stomatitis
         subjects affected / exposed
    8 / 21 (38.10%)
         occurrences all number
    13
    Gastritis
         subjects affected / exposed
    12 / 21 (57.14%)
         occurrences all number
    19
    Flatulence
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Abdominal pain upper
         subjects affected / exposed
    3 / 21 (14.29%)
         occurrences all number
    4
    Dyspepsia
         subjects affected / exposed
    6 / 21 (28.57%)
         occurrences all number
    6
    Diarrhoea
         subjects affected / exposed
    10 / 21 (47.62%)
         occurrences all number
    13
    Dry mouth
         subjects affected / exposed
    3 / 21 (14.29%)
         occurrences all number
    4
    Abdominal distension
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Odynophagia
         subjects affected / exposed
    4 / 21 (19.05%)
         occurrences all number
    4
    Haemorrhoids
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hepatotoxicity
         subjects affected / exposed
    4 / 21 (19.05%)
         occurrences all number
    6
    Hypertransaminasaemia
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    10 / 21 (47.62%)
         occurrences all number
    12
    Rash erythematous
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Rash scarlatiniform
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    10 / 21 (47.62%)
         occurrences all number
    14
    Herpes zoster
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Nail dystrophy
         subjects affected / exposed
    17 / 21 (80.95%)
         occurrences all number
    22
    Erythema
         subjects affected / exposed
    4 / 21 (19.05%)
         occurrences all number
    4
    Skin hyperpigmentation
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Nail pigmentation
         subjects affected / exposed
    3 / 21 (14.29%)
         occurrences all number
    3
    Dry skin
         subjects affected / exposed
    5 / 21 (23.81%)
         occurrences all number
    5
    Skin reaction
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Skin toxicity
         subjects affected / exposed
    4 / 21 (19.05%)
         occurrences all number
    5
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    18 / 21 (85.71%)
         occurrences all number
    27
    Pain in extremity
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Pain in jaw
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    5 / 21 (23.81%)
         occurrences all number
    6
    Osteoarthritis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Conjunctivitis
         subjects affected / exposed
    15 / 21 (71.43%)
         occurrences all number
    23
    Oropharyngeal candidiasis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Oral candidiasis
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Gingivitis
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    8 / 21 (38.10%)
         occurrences all number
    8

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jan 2011
    New participating center.
    05 Apr 2011
    Various protocol and HIP modifications
    05 Mar 2012
    Modification of the number of patients
    04 Apr 2012
    Radiation therapy in centers of origin
    05 Jul 2012
    Change of Sponsor
    02 Nov 2012
    CAIBER output
    02 Jul 2013
    PEI 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
    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.

    European Medicines Agency © 1995-Fri Apr 26 21:57:08 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA