Study Stopped
Terminated: Amgen decision following Primary Analysis. Not due to safety reason
Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)
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)
2 other identifiers
interventional
4,509
38 countries
452
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Jun 2010
Typical duration for phase_3 breast-cancer
452 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2010
CompletedFirst Posted
Study publicly available on registry
February 26, 2010
CompletedStudy Start
First participant enrolled
June 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2018
CompletedResults Posted
Study results publicly available
October 3, 2018
CompletedSeptember 28, 2021
September 1, 2021
7.3 years
February 4, 2010
August 13, 2018
September 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone Metastasis-free Survival (BMFS)
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.
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.
Secondary Outcomes (4)
Disease-free Survival (DFS)
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.
Disease-free Survival (DFS) in the Postmenopausal Subset
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.
Overall Survival
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.
Distant Recurrence-free Survival
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.
Study Arms (2)
Placebo
PLACEBO COMPARATORParticipants received placebo subcutaneous injections once every 4 weeks for 6 months followed by placebo subcutaneous injections once every 3 months for 4.5 years.
Denosumab
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
- +2 more criteria
You may not qualify if:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
- Daiichi Sankyocollaborator
Study Sites (459)
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Birmingham, Alabama, 35205, United States
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Tucson, Arizona, 85724, United States
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Jonesboro, Arkansas, 72401, United States
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Alhambra, California, 91801, United States
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Anaheim, California, 92801, United States
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Beverly Hills, California, 90211, United States
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Campbell, California, 95008, United States
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Fresno, California, 93720, United States
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Fullerton, California, 92835, United States
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La Verne, California, 91750, United States
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Lancaster, California, 93534, United States
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Long Beach, California, 90813, United States
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Los Angeles, California, 90024, United States
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Los Angeles, California, 90025, United States
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Los Angeles, California, 90095-1772, United States
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Northridge, California, 91328, United States
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Redondo Beach, California, 90277, United States
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Santa Barbara, California, 93105, United States
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Santa Maria, California, 93454, United States
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Torrance, California, 90502, United States
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Denver, Colorado, 80220, United States
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Grand Junction, Colorado, 81501, United States
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New Haven, Connecticut, 06510, United States
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Boynton Beach, Florida, 33435, United States
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Coral Springs, Florida, 33065, United States
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Fort Lauderdale, Florida, 33316, United States
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Hollywood, Florida, 33021, United States
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Jacksonville, Florida, 32256, United States
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Melbourne, Florida, 32901, United States
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Athens, Georgia, 30607, United States
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Niles, Illinois, 60714, United States
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Indianapolis, Indiana, 46260, United States
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Cedar Rapids, Iowa, 52402, United States
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Hutchinson, Kansas, 67502, United States
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Wichita, Kansas, 67214, United States
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Paducah, Kentucky, 42003, United States
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Annapolis, Maryland, 21401, United States
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Baltimore, Maryland, 21201, United States
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Bethesda, Maryland, 20817, United States
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Columbia, Maryland, 21044, United States
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Boston, Massachusetts, 02114, United States
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Danvers, Massachusetts, 01923, United States
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Ann Arbor, Michigan, 48109, United States
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Detroit, Michigan, 48201, United States
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Edina, Minnesota, 55435, United States
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Minneapolis, Minnesota, 55407, United States
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Saint Louis Park, Minnesota, 55426, United States
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Jackson, Mississippi, 39202, United States
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Jefferson City, Missouri, 65109, United States
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Lincoln, Nebraska, 68510, United States
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Henderson, Nevada, 89052, United States
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Lebanon, New Hampshire, 03756-0001, United States
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Denville, New Jersey, 07834, United States
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Hackensack, New Jersey, 07601, United States
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East Setauket, New York, 11733, United States
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New York, New York, 10003, United States
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New York, New York, 10029, United States
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New York, New York, 10032, United States
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Nyack, New York, 10960, United States
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Asheville, North Carolina, 28806, United States
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High Point, North Carolina, 27262, United States
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Cincinnati, Ohio, 45242, United States
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Columbus, Ohio, 43210, United States
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Tulsa, Oklahoma, 74136, United States
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Hershey, Pennsylvania, 17033, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Pawtucket, Rhode Island, 02860, United States
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Charleston, South Carolina, 29414, United States
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Columbia, South Carolina, 29210, United States
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Hilton Head Island, South Carolina, 29926, United States
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Sioux Falls, South Dakota, 57105, United States
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Chattanooga, Tennessee, 37404, United States
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Germantown, Tennessee, 38138, United States
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Nashville, Tennessee, 37203, United States
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Abilene, Texas, 79606-5208, United States
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Corpus Christi, Texas, 78463, United States
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Dallas, Texas, 75230-2510, United States
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Dallas, Texas, 75246, United States
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Dallas, Texas, 75390, United States
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El Paso, Texas, 79902, United States
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Garland, Texas, 75042, United States
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Houston, Texas, 77024, United States
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Houston, Texas, 77030, United States
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Plano, Texas, 75075, United States
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San Antonio, Texas, 78217, United States
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San Antonio, Texas, 78229, United States
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Tyler, Texas, 75702, United States
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Richlands, Virginia, 24641, United States
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Richmond, Virginia, 23230, United States
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Roanoke, Virginia, 24014, United States
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Seattle, Washington, 98109-1023, United States
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Seattle, Washington, 98133, United States
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Tacoma, Washington, 98405, United States
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Quilmes, Buenos Aires, B1878DVB, Argentina
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Quilmes, Buenos Aires, B1878GEG, Argentina
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San Martín, Buenos Aires, B1650BOB, Argentina
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Neuquén, Neuquén, Q8300HDH, Argentina
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Provincia de Santa Fe, Santa Fe Province, S3000FFV, Argentina
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San Miguel de Tucumán, Tucumán Province, T4000GTB, Argentina
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Camperdown, New South Wales, 2050, Australia
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Caringbah, New South Wales, 2229, Australia
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Kogarah, New South Wales, 2217, Australia
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Tweed Heads, New South Wales, 2485, Australia
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Wahroonga, New South Wales, 2076, Australia
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Bedford Park, South Australia, 5042, Australia
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Bentleigh East, Victoria, 3165, Australia
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East Melbourne, Victoria, 3002, Australia
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Fitzroy, Victoria, 3065, Australia
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Footscray, Victoria, 3011, Australia
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Frankston, Victoria, 3199, Australia
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Heidelberg, Victoria, 3084, Australia
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Malvern, Victoria, 3144, Australia
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Parkville, Victoria, 3050, Australia
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Richmond, Victoria, 3121, Australia
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Ringwood East, Victoria, 3135, Australia
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Warrnambool, Victoria, 3280, Australia
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Wodonga, Victoria, 3690, Australia
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Perth, Western Australia, 6000, Australia
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Subiaco, Western Australia, 6008, Australia
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Antwerp, 2020, Belgium
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Bonheiden, 2820, Belgium
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Bruges, 8000, Belgium
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Brussels, 1020, Belgium
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Brussels, 1090, Belgium
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Brussels, 1200, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Hasselt, 3500, Belgium
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Kortrijk, 8500, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Libramont, 6800, Belgium
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Namur, 5000, Belgium
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Ostend, 8400, Belgium
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Ottignies, 1340, Belgium
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Sint-Niklaas, 9100, Belgium
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Tournai, 7500, Belgium
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Wilrijk, 2610, Belgium
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Yvoir, 5530, Belgium
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Salvador, Estado de Bahia, 40950-640, Brazil
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Salvador, Estado de Bahia, 41820-021, Brazil
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Curitiba, Paraná, 81520-060, Brazil
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Londrina, Paraná, 86050-190, Brazil
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Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
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Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
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ItajaÃ-, Santa Catarina, 88301-220, Brazil
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Barretos, São Paulo, 14784-400, Brazil
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Santo André, São Paulo, 09080-110, Brazil
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São Paulo, São Paulo, 04038-034, Brazil
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São Paulo, São Paulo, 01246-000, Brazil
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São Paulo, São Paulo, 01317-000, Brazil
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Plovdiv, 4004, Bulgaria
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Rousse, 7002, Bulgaria
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Sofia, 1756, Bulgaria
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Sofia, 1784, Bulgaria
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Stara Zagora, 6003, Bulgaria
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Varna, 9000, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Calgary, Alberta, T2N 4N2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Kelowna, British Columbia, V1Y 5L3, Canada
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Victoria, British Columbia, V8R 6V5, Canada
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Moncton, New Brunswick, E1C 6Z8, Canada
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St. John's, Newfoundland and Labrador, A1B 3V6, Canada
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Sydney, Nova Scotia, B1P 1P3, Canada
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Barrie, Ontario, L4M 6M2, Canada
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Brampton, Ontario, L6R 3J7, Canada
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Greater Sudbury, Ontario, P3E 5J1, Canada
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Kingston, Ontario, K7L 5P9, Canada
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Kitchener, Ontario, N2G 1G3, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Sault Ste. Marie, Ontario, P6B 0A8, Canada
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Toronto, Ontario, M4C 3E7, Canada
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Toronto, Ontario, M9N 1N8, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H2W 1T8, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Québec, Quebec, G1S 4L8, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Temuco, CautÃ-n, 4810469, Chile
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Viña del Mar, ValparaÃ-so, 2520612, Chile
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Santiago, 8380455, Chile
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Brno, 625 00, Czechia
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Brno, 656 53, Czechia
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Chomutov, 430 12, Czechia
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Hořovice, 268 31, Czechia
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Hradec Králové, 500 05, Czechia
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Olomouc, 775 20, Czechia
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Prague, 100 00, Czechia
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Prague, 100 34, Czechia
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Prague, 140 44, Czechia
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Prague, 150 06, Czechia
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Prague, 180 81, Czechia
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Ã…rhus C, 8000, Denmark
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Herning, 7400, Denmark
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Vejle, 7100, Denmark
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Viborg, 8800, Denmark
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Angers, 49933, France
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Bordeaux, 33030, France
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Dijon, 21079, France
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Grenoble, 38000, France
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Hyères, 83400, France
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Le Mans, 72000, France
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Lille, 59000, France
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Monaco, 98012, France
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Nantes, 44202, France
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Paris, 75012, France
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Pierre-Bénite, 69495, France
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Saint-Priest-en-Jarez, 42270, France
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Strasbourg, 67091, France
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Villejuif, 94805, France
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Berlin, 10117, Germany
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Berlin, 10713, Germany
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Bonn, 53111, Germany
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Bottrop, 46236, Germany
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Erlangen, 91054, Germany
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Frankfurt, 60590, Germany
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Kiel, 24105, Germany
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Koblenz, 56068, Germany
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Mannheim, 68161, Germany
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München, 80335, Germany
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München, 80638, Germany
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München, 81675, Germany
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Recklinghausen, 45657, Germany
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Rostock, 18059, Germany
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Tübingen, 72076, Germany
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Trier, 54290, Germany
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Athens, 11522, Greece
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Athens, 11528, Greece
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Heraklion, 71110, Greece
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Pátrai, 26500, Greece
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Thessaloniki, 54636, Greece
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Thessaloniki, 56429, Greece
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Hong Kong, Hong Kong
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New Territories, Hong Kong
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Budapest, 1032, Hungary
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Budapest, 1062, Hungary
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Budapest, 1082, Hungary
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Budapest, 1122, Hungary
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Budapest, 1125, Hungary
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Budapest, 1145, Hungary
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Debrecen, 4012, Hungary
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Győr, 9023, Hungary
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Nyíregyháza, 4400, Hungary
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Pécs, 7624, Hungary
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Szeged, 6725, Hungary
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Székesfehérvár, 8000, Hungary
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Szolnok, 5004, Hungary
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Zalaegerszeg, 8900, Hungary
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Hyderabad, Andhra Pradesh, 500 024, India
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Bangalore, Karnataka, 560 054, India
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Ahilyanagar, Maharashtra, 413 736, India
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Aurangabad, Maharashtra, 431 001, India
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Miraj, Maharashtra, 416 410, India
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Mumbai, Maharashtra, 400 012, India
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Mumbai, Maharashtra, 400 016, India
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Nashik, Maharashtra, 422 004, India
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Nashik, Maharashtra, 422 005, India
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Pune, Maharashtra, 411 001, India
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Jaipur, Rajasthan, 302 013, India
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Chennai, Tamil Nadu, 600 018, India
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Madurai, Tamil Nadu, 625 107, India
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Cork, Ireland
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Dublin, 4, Ireland
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Dublin, 8, Ireland
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Dublin, 9, Ireland
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Limerick, Ireland
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Waterford, Ireland
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Ashkelon, 78278, Israel
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Haifa, 31096, Israel
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Jerusalem, 91031, Israel
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Kfar Saba, 44281, Israel
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Petah Tikva, 49100, Israel
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Poria Eylit, 15208, Israel
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Rehovot, 76100, Israel
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Tel Aviv, 64239, Israel
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Tel Aviv, 69710, Israel
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Ancona, 60131, Italy
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Bari, 70124, Italy
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Brescia, 25123, Italy
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Meldola FC, 47014, Italy
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Milan, 20142, Italy
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Monza (MB), 20900, Italy
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Palermo, 90100, Italy
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Parma, 43100, Italy
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San Giovanni Rotondo FG, 71013, Italy
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Treviglio (BG), 24047, Italy
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Varese, 21100, Italy
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Nagoya, Aichi-ken, 464-8681, Japan
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Nagoya, Aichi-ken, 467-8602, Japan
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Matsuyama, Ehime, 791-0280, Japan
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Fukuoka, Fukuoka, 811-1395, Japan
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Kitakyushu-shi, Fukuoka, 802-0077, Japan
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Kurume-shi, Fukuoka, 830-0013, Japan
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Kure-shi, Hiroshima, 737-0023, Japan
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Akashi-shi, Hyōgo, 673-8558, Japan
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Kagoshima, Kagoshima-ken, 892-0833, Japan
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Isehara-shi, Kanagawa, 259-1193, Japan
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Kumamoto, Kumamoto, 860-8556, Japan
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Kyoto, Kyoto, 606-8507, Japan
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Miyazaki, Miyazaki, 880-0052, Japan
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Niigata, Niigata, 951-8566, Japan
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Kurashiki-shi, Okayama-ken, 701-0192, Japan
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Osaka, Osaka, 537-8511, Japan
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Osaka, Osaka, 540-0006, Japan
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Suita-shi, Osaka, 565-0871, Japan
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Hidaka-Shi, Saitama, 350-1298, Japan
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Kitaadachi-gun, Saitama, 362-0806, Japan
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Suntou-gun, Shizuoka, 411-8777, Japan
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Shimotsuke-shi, Tochigi, 329-0498, Japan
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Utsunomiya, Tochigi, 320-0834, Japan
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Chuo-ku, Tokyo, 104-0045, Japan
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Tokyo, 135-8550, Japan
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Tokyo, 142-8666, Japan
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Tokyo, 160-0023, Japan
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Tokyo, 173-0003, Japan
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Daugavpils, 5417, Latvia
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Liepāja, 3401, Latvia
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Riga, 1079, Latvia
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Kota Bharu, Kelantan, 16150, Malaysia
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Kuala Lumpur, Kuala Lumpur, 50703, Malaysia
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Kuala Lumpur, Kuala Lumpur, 56000, Malaysia
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Subang Jaya, Selangor (incl. Putrajaya), 47500, Malaysia
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León, Guanajuato, 37670, Mexico
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Pachuca, Hidalgo, 42084, Mexico
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Mexico City, Mexico City, 01120, Mexico
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Mexico City, Mexico City, 06726, Mexico
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Mexico City, Mexico City, 07760, Mexico
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Monterrey, Nuevo León, 64000, Mexico
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Querétaro, Querétaro, 76178, Mexico
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San Luis Potosí City, San Luis PotosÃ-, 78200, Mexico
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Colima, 28030, Mexico
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Distrito Federal, 11000, Mexico
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Durango, 34000, Mexico
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Toluca, 50180, Mexico
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Amsterdam, 1066 CX, Netherlands
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Bergen op Zoom, 4624 VT, Netherlands
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Breda, 4819 EV, Netherlands
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Capelle aan den IJssel, 2906 ZC, Netherlands
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Dordrecht, 3318 AT, Netherlands
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Hoofddorp, 2134 TM, Netherlands
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Leiden, 2333 ZA, Netherlands
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Nieuwegein, 3435 CM, Netherlands
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Rotterdam, 3045 PM, Netherlands
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Rotterdam, 3075 EA, Netherlands
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Schiedam, 3118 JH, Netherlands
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Sittard-Geleen, 6162 BG, Netherlands
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The Hague, 2545 CH, Netherlands
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Tiel, 4002 WP, Netherlands
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Tilburg, 5022 GC, Netherlands
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Venlo, 5912 BL, Netherlands
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Lima, Lima 11, Peru
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Lima, Lima 18, Peru
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Lima, Lima 27, Peru
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Cebu City, 6000, Philippines
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Manila, 1000, Philippines
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Manila, 1008, Philippines
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Metro Manila, 1100, Philippines
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Quezon City, 1102, Philippines
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Gdansk, 80-219, Poland
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Gdansk, 80-952, Poland
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Krakow, 31-108, Poland
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Olsztyn, 10-228, Poland
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Poznan, 61-485, Poland
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Rzeszów, 35-021, Poland
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Szczecin, 71-730, Poland
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Lisbon, 1099-023, Portugal
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Lisbon, 1500-650, Portugal
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Porto, 4200-072, Portugal
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Related Publications (3)
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.
PMID: 31806543BACKGROUNDColeman 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.
PMID: 34185259BACKGROUNDAdams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
PMID: 38979716DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2010
First Posted
February 26, 2010
Study Start
June 2, 2010
Primary Completion
August 31, 2017
Study Completion
March 26, 2018
Last Updated
September 28, 2021
Results First Posted
October 3, 2018
Record last verified: 2021-09