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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01077154
Registration number
NCT01077154
Ethics application status
Date submitted
4/02/2010
Date registered
26/02/2010
Date last updated
28/09/2021
Titles & IDs
Public title
Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women With Early-Stage Breast Cancer at High Risk of Recurrence (D-CARE)
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Secondary ID [1]
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0
2009-011299-32
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Secondary ID [2]
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20060359
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Denosumab
Placebo comparator: Placebo - Participants received placebo subcutaneous injections once every 4 weeks for 6 months followed by placebo subcutaneous injections once every 3 months for 4.5 years.
Experimental: Denosumab - Participants received denosumab 120 mg subcutaneous injections once every 4 weeks for 6 months followed by denosumab 120 mg subcutaneous injections once every 3 months for 4.5 years.
Treatment: Drugs: Placebo
Administered subcutaneously for up to 5 years
Treatment: Drugs: Denosumab
Administered subcutaneously for up to 5 years
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Bone Metastasis-free Survival (BMFS)
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Assessment method [1]
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BMFS time was defined as the time interval from the randomization date to the first occurrence of bone metastasis or death from any cause, whichever came first. Participants last known to be alive with no bone metastasis were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first occurrence of bone metastasis before randomization were censored at their randomization date.
Bone metastasis must have been confirmed by central imaging analysis or by biopsy, Evidence of disseminated tumor cells in bone marrow was not sufficient for determination of disease recurrence. Development of new primary malignancy in bone was not considered as bone metastasis.
Since the median BMSF time could not be estimated due to low number of events, the percentage of participants with an event (i.e., bone metastasis or death) is reported.
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Timepoint [1]
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From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively.
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Secondary outcome [1]
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Disease-free Survival (DFS)
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Assessment method [1]
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DFS time was defined as the time interval from the randomization date to the date of first observation of disease recurrence or death from any cause, whichever was first. Participants last known to be alive with no disease recurrence were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first disease recurrence before randomization were censored at their randomization date.
Disease recurrence includes bone metastasis and extraosseous disease (EOD) confirmed by central imaging analysis or by biopsy/cytology. Development of non-breast cancer new primary malignancy was not considered as disease recurrence.
Since the median DFS time could not be estimated due to low number of events, the percentage of participants with an event (i.e., disease recurrence or death) is reported.
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Timepoint [1]
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From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively.
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Secondary outcome [2]
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Disease-free Survival (DFS) in the Postmenopausal Subset
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Assessment method [2]
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DFS time was defined as the time interval from the randomization date to the date of first observation of disease recurrence or death from any cause, whichever was first. Participants last known to be alive with no disease recurrence were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first disease recurrence before randomization were censored at their randomization date.
Disease recurrence includes bone metastasis and extraosseous disease (EOD) confirmed by central imaging analysis or by biopsy/cytology. Development of non-breast cancer new primary malignancy was not considered as disease recurrence.
Since the median DFS time in the postmenopausal subset could not be estimated due to low number of events, the percentage of participants with an event (i.e., disease recurrence or death) is reported.
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Timepoint [2]
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From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively.
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Secondary outcome [3]
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Overall Survival
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Assessment method [3]
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Overall survival (OS) time was defined as the time interval from the randomization date to the date of death from any cause. Participants last known to be alive were censored at their last contact date.
Since the median time to overall survival could not be estimated at the time of the final analysis due to low numbers of events, the percentage of participants with an event (i.e., death) is reported.
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Timepoint [3]
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From randomization until the end of study; median (minimum, maximum) time on study was 72.7 (0, 92) and 72.3 (0, 92) months in each treatment group respectively.
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Secondary outcome [4]
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Distant Recurrence-free Survival
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Assessment method [4]
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Distant recurrence-free survival (DRFS) was defined as the time interval from the randomization date to the date of first observation of distant disease recurrence or death from any cause, whichever came first. Participants last known to be alive, who had not experienced distant disease recurrence, were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first distant recurrence before randomization were censored at their randomization date.
Distant disease recurrence includes confirmed bone metastasis and extraosseous disease other than local-regional disease recurrence. Development of non-breast cancer new primary malignancy was not considered as distant disease recurrence.
Since the median time to DRFS could not be estimated due to the low number of events, the percentage of participants with an event (i.e., distant recurrence or death) is reported.
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Timepoint [4]
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From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively.
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Eligibility
Key inclusion criteria
* Histologically confirmed, American Joint Committee on Cancer (AJCC) stage II or III breast cancer
* High risk of breast cancer recurrence, defined as documented evidence of one or more of the following criteria:
i) Biopsy evidence of breast cancer in regional lymph node(s) (LN) (node-positive disease); Nodal micrometastases only are not considered node positive ii) Tumor size > 5 cm (T3) or locally advanced disease (T4)
* Documented pathological evaluation of the breast cancer for hormone receptor (estrogen receptor [ER] and progesterone receptor [PR]) status and HER-2 status
* Subjects must be receiving or be scheduled to receive standard of care systemic adjuvant or neoadjuvant chemotherapy and/or endocrine therapy and/or HER-2 targeted therapy
* For subjects receiving adjuvant therapy only:
* subjects must have undergone complete resection of the primary tumor with clean surgical margins, or subjects must have undergone resection of the primary tumor and be scheduled for further treatment of the primary tumor with curative intent. Definitive treatment must be planned to be completed within approximately 9 months of randomization
* Time between definitive surgery and randomization must be = 12 weeks. Definitive surgery may include secondary interventions (e.g. to clear inadequate surgical margins)
* Subjects with node positive disease must have undergone treatment of axillary LN with curative intent, or subjects must be scheduled for further treatment of regional lymph nodes with curative intent. Definitive treatment must be planned to be completed within approximately 9 months of randomization
* Subjects must not have received prior neoadjuvant treatment. Endocrine treatment for less than 30 days prior to surgery is not considered prior neoadjuvant treatment
* For subjects receiving neoadjuvant therapy only:
* Time between start of neoadjuvant treatment and randomization must be = 8 weeks and subjects must be scheduled to undergo definitive treatment (including surgery and/or radiotherapy) with curative intent within approximately 9 months of starting neoadjuvant treatment
* Female subjects with age = 18 years
* Subjects with reproductive potential must have a negative pregnancy test within 14 days before randomization
* Serum calcium or albumin-adjusted serum calcium = 2.0 mmol/L (8.0 mg/dL) and = 2.9 mmol/L (11.5 mg/dL)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Written informed consent before any study-specific procedure is performed
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Prior or current evidence of any metastatic involvement of any distant site
* History of breast cancer (other than ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS]) prior to the current diagnosis
* Osteoporosis requiring treatment at the time of randomization or treatment considered likely to become necessary within the subsequent six months
* Any prior or synchronous malignancy (other than breast cancer), except i) Malignancy treated with curative intent and with no evidence of disease for = 5 years prior to enrollment and considered to be at low risk for recurrence by the treating physician ii) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
* Active infection with Hepatitis B virus or Hepatitis C virus
* Known infection with human immunodeficiency virus (HIV)
* Prior history or current evidence of osteomyelitis/osteonecrosis of the jaw
* Active dental or jaw condition which requires oral surgery
* Planned invasive dental procedure for the course of the study
* Non-healed dental or oral surgery
* Use of oral bisphosphonates within the past 1 year
* Prior or current IV bisphosphonate administration
* Prior administration of denosumab
* Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or investigational drug study(s), or subject is receiving other investigational agent(s)
* Subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment.
* Subject is of child bearing potential and is not willing to use, in combination with her partner, 2 highly effective methods of contraception or abstinence during treatment and for 5 months after the end of treatment
* Subject has known sensitivity to any of the products to be administered during the study (e.g., mammalian derived products, calcium, or vitamin D)
* Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
* Any major medical or psychiatric disorder that in the opinion of the investigator prevent the subject from completing the study or interfere with the interpretation of the study results
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/06/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/03/2018
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Sample size
Target
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Accrual to date
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Final
4509
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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2050 - Camperdown
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2229 - Caringbah
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2217 - Kogarah
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2485 - Tweed Heads
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2076 - Wahroonga
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5042 - Bedford Park
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3165 - Bentleigh East
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3002 - East Melbourne
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3065 - Fitzroy
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3011 - Footscray
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3199 - Frankston
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3084 - Heidelberg
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3144 - Malvern
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3121 - Richmond
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3135 - Ringwood East
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3280 - Warrnambool
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3690 - Wodonga
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6000 - Perth
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0
0
CautÃ-n
Query!
Country [78]
0
0
Chile
Query!
State/province [78]
0
0
ValparaÃ-so
Query!
Country [79]
0
0
Chile
Query!
State/province [79]
0
0
Santiago
Query!
Country [80]
0
0
Czechia
Query!
State/province [80]
0
0
Brno
Query!
Country [81]
0
0
Czechia
Query!
State/province [81]
0
0
Chomutov
Query!
Country [82]
0
0
Czechia
Query!
State/province [82]
0
0
Horovice
Query!
Country [83]
0
0
Czechia
Query!
State/province [83]
0
0
Hradec Kralove
Query!
Country [84]
0
0
Czechia
Query!
State/province [84]
0
0
Olomouc
Query!
Country [85]
0
0
Czechia
Query!
State/province [85]
0
0
Praha 10
Query!
Country [86]
0
0
Czechia
Query!
State/province [86]
0
0
Praha 4
Query!
Country [87]
0
0
Czechia
Query!
State/province [87]
0
0
Praha 5
Query!
Country [88]
0
0
Czechia
Query!
State/province [88]
0
0
Praha 8
Query!
Country [89]
0
0
Denmark
Query!
State/province [89]
0
0
Herning
Query!
Country [90]
0
0
Denmark
Query!
State/province [90]
0
0
Vejle
Query!
Country [91]
0
0
Denmark
Query!
State/province [91]
0
0
Viborg
Query!
Country [92]
0
0
Denmark
Query!
State/province [92]
0
0
Ã…rhus C
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Angers
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Bordeaux Cedex
Query!
Country [95]
0
0
France
Query!
State/province [95]
0
0
Dijon
Query!
Country [96]
0
0
France
Query!
State/province [96]
0
0
Grenoble
Query!
Country [97]
0
0
France
Query!
State/province [97]
0
0
Hyères
Query!
Country [98]
0
0
France
Query!
State/province [98]
0
0
Le Mans
Query!
Country [99]
0
0
France
Query!
State/province [99]
0
0
Lille
Query!
Country [100]
0
0
France
Query!
State/province [100]
0
0
Monaco
Query!
Country [101]
0
0
France
Query!
State/province [101]
0
0
Nantes Cedex 2
Query!
Country [102]
0
0
France
Query!
State/province [102]
0
0
Paris
Query!
Country [103]
0
0
France
Query!
State/province [103]
0
0
Pierre-Benite
Query!
Country [104]
0
0
France
Query!
State/province [104]
0
0
Saint Priest en Jarez Cedex
Query!
Country [105]
0
0
France
Query!
State/province [105]
0
0
Strasbourg cedex
Query!
Country [106]
0
0
France
Query!
State/province [106]
0
0
Villejuif cedex
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Berlin
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Bonn
Query!
Country [109]
0
0
Germany
Query!
State/province [109]
0
0
Bottrop
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
Erlangen
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Frankfurt
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Kiel
Query!
Country [113]
0
0
Germany
Query!
State/province [113]
0
0
Koblenz
Query!
Country [114]
0
0
Germany
Query!
State/province [114]
0
0
Mannheim
Query!
Country [115]
0
0
Germany
Query!
State/province [115]
0
0
München
Query!
Country [116]
0
0
Germany
Query!
State/province [116]
0
0
Recklinghausen
Query!
Country [117]
0
0
Germany
Query!
State/province [117]
0
0
Rostock
Query!
Country [118]
0
0
Germany
Query!
State/province [118]
0
0
Trier
Query!
Country [119]
0
0
Germany
Query!
State/province [119]
0
0
Tübingen
Query!
Country [120]
0
0
Greece
Query!
State/province [120]
0
0
Athens
Query!
Country [121]
0
0
Greece
Query!
State/province [121]
0
0
Heraklion
Query!
Country [122]
0
0
Greece
Query!
State/province [122]
0
0
Patra
Query!
Country [123]
0
0
Greece
Query!
State/province [123]
0
0
Thessaloniki
Query!
Country [124]
0
0
Hong Kong
Query!
State/province [124]
0
0
Hong Kong
Query!
Country [125]
0
0
Hong Kong
Query!
State/province [125]
0
0
New Territories
Query!
Country [126]
0
0
Hungary
Query!
State/province [126]
0
0
Budapest
Query!
Country [127]
0
0
Hungary
Query!
State/province [127]
0
0
Debrecen
Query!
Country [128]
0
0
Hungary
Query!
State/province [128]
0
0
Gyor
Query!
Country [129]
0
0
Hungary
Query!
State/province [129]
0
0
Nyiregyhaza
Query!
Country [130]
0
0
Hungary
Query!
State/province [130]
0
0
Pecs
Query!
Country [131]
0
0
Hungary
Query!
State/province [131]
0
0
Szeged
Query!
Country [132]
0
0
Hungary
Query!
State/province [132]
0
0
Szekesfehervar
Query!
Country [133]
0
0
Hungary
Query!
State/province [133]
0
0
Szolnok
Query!
Country [134]
0
0
Hungary
Query!
State/province [134]
0
0
Zalaegerszeg
Query!
Country [135]
0
0
India
Query!
State/province [135]
0
0
Andhra Pradesh
Query!
Country [136]
0
0
India
Query!
State/province [136]
0
0
Karnataka
Query!
Country [137]
0
0
India
Query!
State/province [137]
0
0
Maharashtra
Query!
Country [138]
0
0
India
Query!
State/province [138]
0
0
Rajasthan
Query!
Country [139]
0
0
India
Query!
State/province [139]
0
0
Tamil Nadu
Query!
Country [140]
0
0
Ireland
Query!
State/province [140]
0
0
Cork
Query!
Country [141]
0
0
Ireland
Query!
State/province [141]
0
0
Dublin
Query!
Country [142]
0
0
Ireland
Query!
State/province [142]
0
0
Limerick
Query!
Country [143]
0
0
Ireland
Query!
State/province [143]
0
0
Waterford
Query!
Country [144]
0
0
Israel
Query!
State/province [144]
0
0
Ashkelon
Query!
Country [145]
0
0
Israel
Query!
State/province [145]
0
0
Haifa
Query!
Country [146]
0
0
Israel
Query!
State/province [146]
0
0
Jerusalem
Query!
Country [147]
0
0
Israel
Query!
State/province [147]
0
0
Kfar Sava
Query!
Country [148]
0
0
Israel
Query!
State/province [148]
0
0
Petah Tikva
Query!
Country [149]
0
0
Israel
Query!
State/province [149]
0
0
Poria Eylit
Query!
Country [150]
0
0
Israel
Query!
State/province [150]
0
0
Rehovot
Query!
Country [151]
0
0
Israel
Query!
State/province [151]
0
0
Tel Aviv
Query!
Country [152]
0
0
Italy
Query!
State/province [152]
0
0
Ancona
Query!
Country [153]
0
0
Italy
Query!
State/province [153]
0
0
Bari
Query!
Country [154]
0
0
Italy
Query!
State/province [154]
0
0
Brescia
Query!
Country [155]
0
0
Italy
Query!
State/province [155]
0
0
Meldola FC
Query!
Country [156]
0
0
Italy
Query!
State/province [156]
0
0
Milano
Query!
Country [157]
0
0
Italy
Query!
State/province [157]
0
0
Monza (MB)
Query!
Country [158]
0
0
Italy
Query!
State/province [158]
0
0
Palermo
Query!
Country [159]
0
0
Italy
Query!
State/province [159]
0
0
Parma
Query!
Country [160]
0
0
Italy
Query!
State/province [160]
0
0
San Giovanni Rotondo FG
Query!
Country [161]
0
0
Italy
Query!
State/province [161]
0
0
Treviglio (BG)
Query!
Country [162]
0
0
Italy
Query!
State/province [162]
0
0
Varese
Query!
Country [163]
0
0
Japan
Query!
State/province [163]
0
0
Aichi
Query!
Country [164]
0
0
Japan
Query!
State/province [164]
0
0
Ehime
Query!
Country [165]
0
0
Japan
Query!
State/province [165]
0
0
Fukuoka
Query!
Country [166]
0
0
Japan
Query!
State/province [166]
0
0
Hiroshima
Query!
Country [167]
0
0
Japan
Query!
State/province [167]
0
0
Hyogo
Query!
Country [168]
0
0
Japan
Query!
State/province [168]
0
0
Kagoshima
Query!
Country [169]
0
0
Japan
Query!
State/province [169]
0
0
Kanagawa
Query!
Country [170]
0
0
Japan
Query!
State/province [170]
0
0
Kumamoto
Query!
Country [171]
0
0
Japan
Query!
State/province [171]
0
0
Kyoto
Query!
Country [172]
0
0
Japan
Query!
State/province [172]
0
0
Miyazaki
Query!
Country [173]
0
0
Japan
Query!
State/province [173]
0
0
Niigata
Query!
Country [174]
0
0
Japan
Query!
State/province [174]
0
0
Okayama
Query!
Country [175]
0
0
Japan
Query!
State/province [175]
0
0
Osaka
Query!
Country [176]
0
0
Japan
Query!
State/province [176]
0
0
Saitama
Query!
Country [177]
0
0
Japan
Query!
State/province [177]
0
0
Shizuoka
Query!
Country [178]
0
0
Japan
Query!
State/province [178]
0
0
Tochigi
Query!
Country [179]
0
0
Japan
Query!
State/province [179]
0
0
Tokyo
Query!
Country [180]
0
0
Korea, Republic of
Query!
State/province [180]
0
0
Goyang-si, Gyeonggi-do
Query!
Country [181]
0
0
Korea, Republic of
Query!
State/province [181]
0
0
Incheon
Query!
Country [182]
0
0
Korea, Republic of
Query!
State/province [182]
0
0
Seoul
Query!
Country [183]
0
0
Latvia
Query!
State/province [183]
0
0
Daugavpils
Query!
Country [184]
0
0
Latvia
Query!
State/province [184]
0
0
Liepaja
Query!
Country [185]
0
0
Latvia
Query!
State/province [185]
0
0
Riga
Query!
Country [186]
0
0
Malaysia
Query!
State/province [186]
0
0
Kelantan
Query!
Country [187]
0
0
Malaysia
Query!
State/province [187]
0
0
Selangor (incl. Putrajaya)
Query!
Country [188]
0
0
Malaysia
Query!
State/province [188]
0
0
Wilayah Persekutuan
Query!
Country [189]
0
0
Mexico
Query!
State/province [189]
0
0
Distrito Federal
Query!
Country [190]
0
0
Mexico
Query!
State/province [190]
0
0
Guanajuato
Query!
Country [191]
0
0
Mexico
Query!
State/province [191]
0
0
Hidalgo
Query!
Country [192]
0
0
Mexico
Query!
State/province [192]
0
0
Nuevo León
Query!
Country [193]
0
0
Mexico
Query!
State/province [193]
0
0
Querétaro
Query!
Country [194]
0
0
Mexico
Query!
State/province [194]
0
0
San Luis PotosÃ-
Query!
Country [195]
0
0
Mexico
Query!
State/province [195]
0
0
Colima
Query!
Country [196]
0
0
Mexico
Query!
State/province [196]
0
0
Durango
Query!
Country [197]
0
0
Mexico
Query!
State/province [197]
0
0
Toluca
Query!
Country [198]
0
0
Netherlands
Query!
State/province [198]
0
0
Amsterdam
Query!
Country [199]
0
0
Netherlands
Query!
State/province [199]
0
0
Bergen op Zoom
Query!
Country [200]
0
0
Netherlands
Query!
State/province [200]
0
0
Breda
Query!
Country [201]
0
0
Netherlands
Query!
State/province [201]
0
0
Capelle aan den ijssel
Query!
Country [202]
0
0
Netherlands
Query!
State/province [202]
0
0
Den Haag
Query!
Country [203]
0
0
Netherlands
Query!
State/province [203]
0
0
Dordrecht
Query!
Country [204]
0
0
Netherlands
Query!
State/province [204]
0
0
Hoofddorp
Query!
Country [205]
0
0
Netherlands
Query!
State/province [205]
0
0
Leiden
Query!
Country [206]
0
0
Netherlands
Query!
State/province [206]
0
0
Nieuwegein
Query!
Country [207]
0
0
Netherlands
Query!
State/province [207]
0
0
Rotterdam
Query!
Country [208]
0
0
Netherlands
Query!
State/province [208]
0
0
Schiedam
Query!
Country [209]
0
0
Netherlands
Query!
State/province [209]
0
0
Sittard-Geleen
Query!
Country [210]
0
0
Netherlands
Query!
State/province [210]
0
0
Tiel
Query!
Country [211]
0
0
Netherlands
Query!
State/province [211]
0
0
Tilburg
Query!
Country [212]
0
0
Netherlands
Query!
State/province [212]
0
0
Venlo
Query!
Country [213]
0
0
Peru
Query!
State/province [213]
0
0
Lima
Query!
Country [214]
0
0
Philippines
Query!
State/province [214]
0
0
Cebu City
Query!
Country [215]
0
0
Philippines
Query!
State/province [215]
0
0
Manila
Query!
Country [216]
0
0
Philippines
Query!
State/province [216]
0
0
Metro Manila
Query!
Country [217]
0
0
Philippines
Query!
State/province [217]
0
0
Quezon City
Query!
Country [218]
0
0
Poland
Query!
State/province [218]
0
0
Gdansk
Query!
Country [219]
0
0
Poland
Query!
State/province [219]
0
0
Krakow
Query!
Country [220]
0
0
Poland
Query!
State/province [220]
0
0
Olsztyn
Query!
Country [221]
0
0
Poland
Query!
State/province [221]
0
0
Poznan
Query!
Country [222]
0
0
Poland
Query!
State/province [222]
0
0
Rzeszow
Query!
Country [223]
0
0
Poland
Query!
State/province [223]
0
0
Szczecin
Query!
Country [224]
0
0
Portugal
Query!
State/province [224]
0
0
Lisboa
Query!
Country [225]
0
0
Portugal
Query!
State/province [225]
0
0
Porto
Query!
Country [226]
0
0
Portugal
Query!
State/province [226]
0
0
Santa Maria da Feira
Query!
Country [227]
0
0
Romania
Query!
State/province [227]
0
0
Bucharest
Query!
Country [228]
0
0
Romania
Query!
State/province [228]
0
0
Craiova
Query!
Country [229]
0
0
Romania
Query!
State/province [229]
0
0
Sibiu
Query!
Country [230]
0
0
Romania
Query!
State/province [230]
0
0
Suceava
Query!
Country [231]
0
0
Romania
Query!
State/province [231]
0
0
Timisoara
Query!
Country [232]
0
0
Russian Federation
Query!
State/province [232]
0
0
Barnaul
Query!
Country [233]
0
0
Russian Federation
Query!
State/province [233]
0
0
Chelyabinsk
Query!
Country [234]
0
0
Russian Federation
Query!
State/province [234]
0
0
Ivanovo
Query!
Country [235]
0
0
Russian Federation
Query!
State/province [235]
0
0
Kazan
Query!
Country [236]
0
0
Russian Federation
Query!
State/province [236]
0
0
Moscow
Query!
Country [237]
0
0
Russian Federation
Query!
State/province [237]
0
0
Saint Petersburg
Query!
Country [238]
0
0
Serbia
Query!
State/province [238]
0
0
Belgrade
Query!
Country [239]
0
0
Serbia
Query!
State/province [239]
0
0
Nis
Query!
Country [240]
0
0
Slovakia
Query!
State/province [240]
0
0
Bardejov
Query!
Country [241]
0
0
Slovakia
Query!
State/province [241]
0
0
Kosice
Query!
Country [242]
0
0
Slovakia
Query!
State/province [242]
0
0
Michalovce
Query!
Country [243]
0
0
Slovakia
Query!
State/province [243]
0
0
Poprad
Query!
Country [244]
0
0
Slovakia
Query!
State/province [244]
0
0
Presov
Query!
Country [245]
0
0
Slovakia
Query!
State/province [245]
0
0
Spisska Nova Ves
Query!
Country [246]
0
0
Slovakia
Query!
State/province [246]
0
0
Trebisov
Query!
Country [247]
0
0
Slovenia
Query!
State/province [247]
0
0
Ljublijana
Query!
Country [248]
0
0
Slovenia
Query!
State/province [248]
0
0
Maribor
Query!
Country [249]
0
0
South Africa
Query!
State/province [249]
0
0
Gauteng
Query!
Country [250]
0
0
South Africa
Query!
State/province [250]
0
0
Cape Town
Query!
Country [251]
0
0
South Africa
Query!
State/province [251]
0
0
Pietermaritzburg
Query!
Country [252]
0
0
South Africa
Query!
State/province [252]
0
0
Port Elizabeth
Query!
Country [253]
0
0
South Africa
Query!
State/province [253]
0
0
Pretoria
Query!
Country [254]
0
0
Spain
Query!
State/province [254]
0
0
AndalucÃ-a
Query!
Country [255]
0
0
Spain
Query!
State/province [255]
0
0
Aragón
Query!
Country [256]
0
0
Spain
Query!
State/province [256]
0
0
Cantabria
Query!
Country [257]
0
0
Spain
Query!
State/province [257]
0
0
Cataluña
Query!
Country [258]
0
0
Spain
Query!
State/province [258]
0
0
Comunidad Valenciana
Query!
Country [259]
0
0
Spain
Query!
State/province [259]
0
0
Galicia
Query!
Country [260]
0
0
Spain
Query!
State/province [260]
0
0
Madrid
Query!
Country [261]
0
0
Taiwan
Query!
State/province [261]
0
0
Chiayi
Query!
Country [262]
0
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Taiwan
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Keelung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Turkey
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Ankara
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Bornova-Izmir
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Turkey
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Ä°zmir
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Bebington
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Birmingham
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Brighton
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Bristol
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Cambridge
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Dorset
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Guildford
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Leeds
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London
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Manchester
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Newcastle
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Peterborough
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Poole
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Truro
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Amgen
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Commercial sector/industry
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Daiichi Sankyo
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Ethics approval
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Summary
Brief summary
This randomized phase 3 trial is studying the effect of denosumab to see if it can prevent disease recurrence in the bone or in any other part of the body, when it is given as adjuvant therapy for women with early-stage breast cancer, who are at high risk of disease recurrence.
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Trial website
https://clinicaltrials.gov/study/NCT01077154
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Trial related presentations / publications
Coleman R, Finkelstein DM, Barrios C, Martin M, Iwata H, Hegg R, Glaspy J, Perianez AM, Tonkin K, Deleu I, Sohn J, Crown J, Delaloge S, Dai T, Zhou Y, Jandial D, Chan A. Adjuvant denosumab in early breast cancer (D-CARE): an international, multicentre, randomised, controlled, phase 3 trial. Lancet Oncol. 2020 Jan;21(1):60-72. doi: 10.1016/S1470-2045(19)30687-4. Epub 2019 Dec 2. Coleman R, Zhou Y, Jandial D, Cadieux B, Chan A. Bone Health Outcomes from the International, Multicenter, Randomized, Phase 3, Placebo-Controlled D-CARE Study Assessing Adjuvant Denosumab in Early Breast Cancer. Adv Ther. 2021 Aug;38(8):4569-4580. doi: 10.1007/s12325-021-01812-9. Epub 2021 Jun 29.
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Public notes
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Contacts
Principal investigator
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MD
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Amgen
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/54/NCT01077154/Prot_000.pdf
Statistical analysis plan
Statistical Analysis Plan: SAP 3.0
https://cdn.clinicaltrials.gov/large-docs/54/NCT01077154/SAP_001.pdf
Statistical analysis plan
Statistical Analysis Plan: SAP 3.0 Addendum
https://cdn.clinicaltrials.gov/large-docs/54/NCT01077154/SAP_002.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01077154
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