Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)
NCT ID: NCT01077154
Last Updated: 2021-09-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
4509 participants
INTERVENTIONAL
2010-06-02
2018-03-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer
NCT00089661
Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium
NCT00896454
Prevention of Symptomatic Skeletal Events With Denosumab Administered Every 4 Weeks Versus Every 12 Weeks
NCT02051218
Denosumab for Breast Cancer With Bone Mets
NCT01952054
Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density
NCT00043186
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. Breast cancer therapy/lymph node (LN) status: neoadjuvant therapy/any LN status versus adjuvant therapy/LN negative (based on axillary LN dissection, or based on sentinel node status) versus adjuvant therapy/LN positive
2. Hormone receptor (estrogen receptor \[ER\]/progesterone receptor \[PR\]) status: ER and/or PR positive versus ER and PR negative
3. Human epidermal growth factor receptor 2 (HER-2) status: HER-2 positive versus HER-2 negative
4. Age: \< 50 years versus ≥ 50 years
5. Geographic Region: Japan versus Other regions.
The primary analysis was conducted after all enrolled participants had the opportunity to complete 5 years of treatment from study day 1.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Placebo
Administered subcutaneously for up to 5 years
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.
Denosumab
Administered subcutaneously for up to 5 years
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Administered subcutaneously for up to 5 years
Denosumab
Administered subcutaneously for up to 5 years
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Daiichi Sankyo
INDUSTRY
Amgen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MD
Role: STUDY_DIRECTOR
Amgen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Birmingham, Alabama, United States
Research Site
Tucson, Arizona, United States
Research Site
Jonesboro, Arkansas, United States
Research Site
Alhambra, California, United States
Research Site
Anaheim, California, United States
Research Site
Beverly Hills, California, United States
Research Site
Campbell, California, United States
Research Site
Fresno, California, United States
Research Site
Fullerton, California, United States
Research Site
La Verne, California, United States
Research Site
Lancaster, California, United States
Research Site
Long Beach, California, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
Northridge, California, United States
Research Site
Redondo Beach, California, United States
Research Site
Santa Barbara, California, United States
Research Site
Santa Maria, California, United States
Research Site
Torrance, California, United States
Research Site
Denver, Colorado, United States
Research Site
Grand Junction, Colorado, United States
Research Site
New Haven, Connecticut, United States
Research Site
Boynton Beach, Florida, United States
Research Site
Coral Springs, Florida, United States
Research Site
Fort Lauderdale, Florida, United States
Research Site
Hollywood, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Melbourne, Florida, United States
Research Site
Athens, Georgia, United States
Research Site
Niles, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Cedar Rapids, Iowa, United States
Research Site
Hutchinson, Kansas, United States
Research Site
Wichita, Kansas, United States
Research Site
Paducah, Kentucky, United States
Research Site
Annapolis, Maryland, United States
Research Site
Baltimore, Maryland, United States
Research Site
Bethesda, Maryland, United States
Research Site
Columbia, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Danvers, Massachusetts, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Detroit, Michigan, United States
Research Site
Edina, Minnesota, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Saint Louis Park, Minnesota, United States
Research Site
Jackson, Mississippi, United States
Research Site
Jefferson City, Missouri, United States
Research Site
Lincoln, Nebraska, United States
Research Site
Henderson, Nevada, United States
Research Site
Lebanon, New Hampshire, United States
Research Site
Denville, New Jersey, United States
Research Site
Hackensack, New Jersey, United States
Research Site
East Setauket, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
Nyack, New York, United States
Research Site
Asheville, North Carolina, United States
Research Site
High Point, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Columbus, Ohio, United States
Research Site
Tulsa, Oklahoma, United States
Research Site
Hershey, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Pawtucket, Rhode Island, United States
Research Site
Charleston, South Carolina, United States
Research Site
Columbia, South Carolina, United States
Research Site
Hilton Head Island, South Carolina, United States
Research Site
Sioux Falls, South Dakota, United States
Research Site
Chattanooga, Tennessee, United States
Research Site
Germantown, Tennessee, United States
Research Site
Nashville, Tennessee, United States
Research Site
Abilene, Texas, United States
Research Site
Corpus Christi, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
El Paso, Texas, United States
Research Site
Garland, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Plano, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Tyler, Texas, United States
Research Site
Richlands, Virginia, United States
Research Site
Richmond, Virginia, United States
Research Site
Roanoke, Virginia, United States
Research Site
Seattle, Washington, United States
Research Site
Seattle, Washington, United States
Research Site
Tacoma, Washington, United States
Research Site
Quilmes, Buenos Aires, Argentina
Research Site
Quilmes, Buenos Aires, Argentina
Research Site
San Martín, Buenos Aires, Argentina
Research Site
Neuquén, Neuquén, Argentina
Research Site
Provincia de Santa Fe, Santa Fe Province, Argentina
Research Site
San Miguel de Tucumán, Tucumán Province, Argentina
Research Site
Camperdown, New South Wales, Australia
Research Site
Caringbah, New South Wales, Australia
Research Site
Kogarah, New South Wales, Australia
Research Site
Tweed Heads, New South Wales, Australia
Research Site
Wahroonga, New South Wales, Australia
Research Site
Bedford Park, South Australia, Australia
Research Site
Bentleigh East, Victoria, Australia
Research Site
East Melbourne, Victoria, Australia
Research Site
Fitzroy, Victoria, Australia
Research Site
Footscray, Victoria, Australia
Research Site
Frankston, Victoria, Australia
Research Site
Heidelberg, Victoria, Australia
Research Site
Malvern, Victoria, Australia
Research Site
Parkville, Victoria, Australia
Research Site
Richmond, Victoria, Australia
Research Site
Ringwood East, Victoria, Australia
Research Site
Warrnambool, Victoria, Australia
Research Site
Wodonga, Victoria, Australia
Research Site
Perth, Western Australia, Australia
Research Site
Subiaco, Western Australia, Australia
Research Site
Antwerp, , Belgium
Research Site
Bonheiden, , Belgium
Research Site
Bruges, , Belgium
Research Site
Brussels, , Belgium
Research Site
Brussels, , Belgium
Research Site
Brussels, , Belgium
Research Site
Edegem, , Belgium
Research Site
Ghent, , Belgium
Research Site
Hasselt, , Belgium
Research Site
Kortrijk, , Belgium
Research Site
Leuven, , Belgium
Research Site
Liège, , Belgium
Research Site
Libramont, , Belgium
Research Site
Namur, , Belgium
Research Site
Ostend, , Belgium
Research Site
Ottignies, , Belgium
Research Site
Sint-Niklaas, , Belgium
Research Site
Tournai, , Belgium
Research Site
Wilrijk, , Belgium
Research Site
Yvoir, , Belgium
Research Site
Salvador, Estado de Bahia, Brazil
Research Site
Salvador, Estado de Bahia, Brazil
Research Site
Curitiba, Paraná, Brazil
Research Site
Londrina, Paraná, Brazil
Research Site
Porto Alegre, Rio Grande do Sul, Brazil
Research Site
Porto Alegre, Rio Grande do Sul, Brazil
Research Site
Porto Alegre, Rio Grande do Sul, Brazil
Research Site
ItajaÃ-, Santa Catarina, Brazil
Research Site
Barretos, São Paulo, Brazil
Research Site
Santo André, São Paulo, Brazil
Research Site
São Paulo, São Paulo, Brazil
Research Site
São Paulo, São Paulo, Brazil
Research Site
São Paulo, São Paulo, Brazil
Research Site
Plovdiv, , Bulgaria
Research Site
Rousse, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Stara Zagora, , Bulgaria
Research Site
Varna, , Bulgaria
Research Site
Veliko Tarnovo, , Bulgaria
Research Site
Calgary, Alberta, Canada
Research Site
Edmonton, Alberta, Canada
Research Site
Kelowna, British Columbia, Canada
Research Site
Victoria, British Columbia, Canada
Research Site
Moncton, New Brunswick, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
Research Site
Sydney, Nova Scotia, Canada
Research Site
Barrie, Ontario, Canada
Research Site
Brampton, Ontario, Canada
Research Site
Greater Sudbury, Ontario, Canada
Research Site
Kingston, Ontario, Canada
Research Site
Kitchener, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Sault Ste. Marie, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Greenfield Park, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Sherbrooke, Quebec, Canada
Research Site
Temuco, CautÃ-n, Chile
Research Site
Viña del Mar, ValparaÃ-so, Chile
Research Site
Santiago, , Chile
Research Site
Brno, , Czechia
Research Site
Brno, , Czechia
Research Site
Chomutov, , Czechia
Research Site
Hořovice, , Czechia
Research Site
Hradec Králové, , Czechia
Research Site
Olomouc, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Ã…rhus C, , Denmark
Research Site
Herning, , Denmark
Research Site
Vejle, , Denmark
Research Site
Viborg, , Denmark
Research Site
Angers, , France
Research Site
Bordeaux, , France
Research Site
Dijon, , France
Research Site
Grenoble, , France
Research Site
Hyères, , France
Research Site
Le Mans, , France
Research Site
Lille, , France
Research Site
Monaco, , France
Research Site
Nantes, , France
Research Site
Paris, , France
Research Site
Pierre-Bénite, , France
Research Site
Saint-Priest-en-Jarez, , France
Research Site
Strasbourg, , France
Research Site
Villejuif, , France
Research Site
Berlin, , Germany
Research Site
Berlin, , Germany
Research Site
Bonn, , Germany
Research Site
Bottrop, , Germany
Research Site
Erlangen, , Germany
Research Site
Frankfurt, , Germany
Research Site
Kiel, , Germany
Research Site
Koblenz, , Germany
Research Site
Mannheim, , Germany
Research Site
München, , Germany
Research Site
München, , Germany
Research Site
München, , Germany
Research Site
Recklinghausen, , Germany
Research Site
Rostock, , Germany
Research Site
Tübingen, , Germany
Research Site
Trier, , Germany
Research Site
Athens, , Greece
Research Site
Athens, , Greece
Research Site
Heraklion, , Greece
Research Site
Pátrai, , Greece
Research Site
Thessaloniki, , Greece
Research Site
Thessaloniki, , Greece
Research Site
Hong Kong, , Hong Kong
Research Site
New Territories, , Hong Kong
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Győr, , Hungary
Research Site
Nyíregyháza, , Hungary
Research Site
Pécs, , Hungary
Research Site
Szeged, , Hungary
Research Site
Székesfehérvár, , Hungary
Research Site
Szolnok, , Hungary
Research Site
Zalaegerszeg, , Hungary
Research Site
Hyderabad, Andhra Pradesh, India
Research Site
Bangalore, Karnataka, India
Research Site
Ahilyanagar, Maharashtra, India
Research Site
Aurangabad, Maharashtra, India
Research Site
Miraj, Maharashtra, India
Research Site
Mumbai, Maharashtra, India
Research Site
Mumbai, Maharashtra, India
Research Site
Nashik, Maharashtra, India
Research Site
Nashik, Maharashtra, India
Research Site
Pune, Maharashtra, India
Research Site
Jaipur, Rajasthan, India
Research Site
Chennai, Tamil Nadu, India
Research Site
Madurai, Tamil Nadu, India
Research Site
Cork, , Ireland
Research Site
Dublin, , Ireland
Research Site
Dublin, , Ireland
Research Site
Dublin, , Ireland
Research Site
Limerick, , Ireland
Research Site
Waterford, , Ireland
Research Site
Ashkelon, , Israel
Research Site
Haifa, , Israel
Research Site
Jerusalem, , Israel
Research Site
Kfar Saba, , Israel
Research Site
Petah Tikva, , Israel
Research Site
Poria Eylit, , Israel
Research Site
Rehovot, , Israel
Research Site
Tel Aviv, , Israel
Research Site
Tel Aviv, , Israel
Research Site
Ancona, , Italy
Research Site
Bari, , Italy
Research Site
Brescia, , Italy
Research Site
Meldola FC, , Italy
Research Site
Milan, , Italy
Research Site
Monza (MB), , Italy
Research Site
Palermo, , Italy
Research Site
Parma, , Italy
Research Site
San Giovanni Rotondo FG, , Italy
Research Site
Treviglio (BG), , Italy
Research Site
Varese, , Italy
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Matsuyama, Ehime, Japan
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Kitakyushu-shi, Fukuoka, Japan
Research Site
Kurume-shi, Fukuoka, Japan
Research Site
Kure-shi, Hiroshima, Japan
Research Site
Akashi-shi, Hyōgo, Japan
Research Site
Kagoshima, Kagoshima-ken, Japan
Research Site
Isehara-shi, Kanagawa, Japan
Research Site
Kumamoto, Kumamoto, Japan
Research Site
Kyoto, Kyoto, Japan
Research Site
Miyazaki, Miyazaki, Japan
Research Site
Niigata, Niigata, Japan
Research Site
Kurashiki-shi, Okayama-ken, Japan
Research Site
Osaka, Osaka, Japan
Research Site
Osaka, Osaka, Japan
Research Site
Suita-shi, Osaka, Japan
Research Site
Hidaka-Shi, Saitama, Japan
Research Site
Kitaadachi-gun, Saitama, Japan
Research Site
Suntou-gun, Shizuoka, Japan
Research Site
Shimotsuke-shi, Tochigi, Japan
Research Site
Utsunomiya, Tochigi, Japan
Research Site
Chuo-ku, Tokyo, Japan
Research Site
Tokyo, , Japan
Research Site
Tokyo, , Japan
Research Site
Tokyo, , Japan
Research Site
Tokyo, , Japan
Research Site
Daugavpils, , Latvia
Research Site
Liepāja, , Latvia
Research Site
Riga, , Latvia
Research Site
Kota Bharu, Kelantan, Malaysia
Research Site
Kuala Lumpur, Kuala Lumpur, Malaysia
Research Site
Kuala Lumpur, Kuala Lumpur, Malaysia
Research Site
Subang Jaya, Selangor (incl. Putrajaya), Malaysia
Research Site
León, Guanajuato, Mexico
Research Site
Pachuca, Hidalgo, Mexico
Research Site
Mexico City, Mexico City, Mexico
Research Site
Mexico City, Mexico City, Mexico
Research Site
Mexico City, Mexico City, Mexico
Research Site
Monterrey, Nuevo León, Mexico
Research Site
Querétaro, Querétaro, Mexico
Research Site
San Luis Potosí City, San Luis PotosÃ-, Mexico
Research Site
Colima, , Mexico
Research Site
Distrito Federal, , Mexico
Research Site
Durango, , Mexico
Research Site
Toluca, , Mexico
Research Site
Amsterdam, , Netherlands
Research Site
Bergen op Zoom, , Netherlands
Research Site
Breda, , Netherlands
Research Site
Capelle aan den IJssel, , Netherlands
Research Site
Dordrecht, , Netherlands
Research Site
Hoofddorp, , Netherlands
Research Site
Leiden, , Netherlands
Research Site
Nieuwegein, , Netherlands
Research Site
Rotterdam, , Netherlands
Research Site
Rotterdam, , Netherlands
Research Site
Schiedam, , Netherlands
Research Site
Sittard-Geleen, , Netherlands
Research Site
The Hague, , Netherlands
Research Site
Tiel, , Netherlands
Research Site
Tilburg, , Netherlands
Research Site
Venlo, , Netherlands
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Cebu City, , Philippines
Research Site
Manila, , Philippines
Research Site
Manila, , Philippines
Research Site
Metro Manila, , Philippines
Research Site
Quezon City, , Philippines
Research Site
Gdansk, , Poland
Research Site
Gdansk, , Poland
Research Site
Krakow, , Poland
Research Site
Olsztyn, , Poland
Research Site
Poznan, , Poland
Research Site
Rzeszów, , Poland
Research Site
Szczecin, , Poland
Research Site
Lisbon, , Portugal
Research Site
Lisbon, , Portugal
Research Site
Porto, , Portugal
Research Site
Porto, , Portugal
Research Site
Santa Maria da Feira, , Portugal
Research Site
Bucharest, , Romania
Research Site
Craiova, , Romania
Research Site
Sibiu, , Romania
Research Site
Suceava, , Romania
Research Site
Timișoara, , Romania
Research Site
Barnaul, , Russia
Research Site
Chelyabinsk, , Russia
Research Site
Ivanovo, , Russia
Research Site
Kazan', , Russia
Research Site
Moscow, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Belgrade, , Serbia
Research Site
Niš, , Serbia
Research Site
Bardejov, , Slovakia
Research Site
Košice, , Slovakia
Research Site
Michalovce, , Slovakia
Research Site
Poprad, , Slovakia
Research Site
Prešov, , Slovakia
Research Site
Spišská Nová Ves, , Slovakia
Research Site
Trebišov, , Slovakia
Research Site
Ljublijana, , Slovenia
Research Site
Maribor, , Slovenia
Research Site
Groenkloof, Gauteng, South Africa
Research Site
Johannesburg, Gauteng, South Africa
Research Site
Cape Town, , South Africa
Research Site
Pietermaritzburg, , South Africa
Research Site
Port Elizabeth, , South Africa
Research Site
Pretoria, , South Africa
Research Site
Pretoria, , South Africa
Research Site
Goyang-si, Gyeonggi-do, , South Korea
Research Site
Incheon, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Córdoba, AndalucÃ-a, Spain
Research Site
Cádiz, AndalucÃ-a, Spain
Research Site
Jaén, AndalucÃ-a, Spain
Research Site
Málaga, AndalucÃ-a, Spain
Research Site
Seville, AndalucÃ-a, Spain
Research Site
Zaragoza, Aragón, Spain
Research Site
Santander, Cantabria, Spain
Research Site
Badalona, Cataluña, Spain
Research Site
Barcelona, Cataluña, Spain
Research Site
Barcelona, Cataluña, Spain
Research Site
Barcelona, Cataluña, Spain
Research Site
Barcelona, Cataluña, Spain
Research Site
Girona, Cataluña, Spain
Research Site
Lleida, Cataluña, Spain
Research Site
Sabadell, Cataluña, Spain
Research Site
A Coruña, Galicia, Spain
Research Site
A Coruña, Galicia, Spain
Research Site
Alcorcón, Madrid, Spain
Research Site
Elche, Valencia, Spain
Research Site
Valencia, Valencia, Spain
Research Site
Valencia, Valencia, Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Putzu City, Chiayi, Taiwan
Research Site
Keelung, Keelung, Taiwan
Research Site
Tainan City, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Ä°zmir, , Turkey (Türkiye)
Research Site
Bornova-Izmir, , Turkey (Türkiye)
Research Site
Bebington, , United Kingdom
Research Site
Birmingham, , United Kingdom
Research Site
Brighton, , United Kingdom
Research Site
Bristol, , United Kingdom
Research Site
Cambridge, , United Kingdom
Research Site
Dorset, , United Kingdom
Research Site
Guildford, , United Kingdom
Research Site
Leeds, , United Kingdom
Research Site
London, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Newcastle, , United Kingdom
Research Site
Peterborough, , United Kingdom
Research Site
Plymouth, , United Kingdom
Research Site
Poole, , United Kingdom
Research Site
Portsmouth, , United Kingdom
Research Site
Sheffield, , United Kingdom
Research Site
Truro, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Adams 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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan: SAP 3.0
Document Type: Statistical Analysis Plan: SAP 3.0 Addendum
Related Links
Access external resources that provide additional context or updates about the study.
AmgenTrials clinical trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-011299-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20060359
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.