Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)

A Phase 3 study testing Denosumab in people with Breast Cancer, run by Amgen at 459 sites in 39 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: Denosumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 4,509 participants
Where: 459 sitesin 39 countries
Study dates: 2 Jun 2010to 26 Mar 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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:
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:

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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

Who cannot join

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)

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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

Trial locations and contacts

459 sites in 39 countries.

Country

City, postcode or hospital

459 sites in 39 countries

United States93 sites

Research Site
Abilene, Texas, 79606-5208
Research Site
Alhambra, California, 91801
Research Site
Anaheim, California, 92801
Research Site
Ann Arbor, Michigan, 48109
Research Site
Annapolis, Maryland, 21401
Research Site
Asheville, North Carolina, 28806
Research Site
Athens, Georgia, 30607
Research Site
Baltimore, Maryland, 21201
Research Site
Bethesda, Maryland, 20817
Research Site
Beverly Hills, California, 90211
Research Site
Birmingham, Alabama, 35205
Research Site
Boston, Massachusetts, 02114
Research Site
Boynton Beach, Florida, 33435
Research Site
Campbell, California, 95008
Research Site
Cedar Rapids, Iowa, 52402
Research Site
Charleston, South Carolina, 29414
Research Site
Chattanooga, Tennessee, 37404
Research Site
Cincinnati, Ohio, 45242
Research Site
Columbia, Maryland, 21044
Research Site
Columbia, South Carolina, 29210
Research Site
Columbus, Ohio, 43210
Research Site
Coral Springs, Florida, 33065
Research Site
Corpus Christi, Texas, 78463
Research Site
Dallas, Texas, 75230-2510
Research Site
Dallas, Texas, 75246
Research Site
Dallas, Texas, 75390
Research Site
Danvers, Massachusetts, 01923
Research Site
Denver, Colorado, 80220
Research Site
Denville, New Jersey, 07834
Research Site
Detroit, Michigan, 48201
Research Site
East Setauket, New York, 11733
Research Site
Edina, Minnesota, 55435
Research Site
El Paso, Texas, 79902
Research Site
Fort Lauderdale, Florida, 33316
Research Site
Fresno, California, 93720
Research Site
Fullerton, California, 92835
Research Site
Garland, Texas, 75042
Research Site
Germantown, Tennessee, 38138
Research Site
Grand Junction, Colorado, 81501
Research Site
Hackensack, New Jersey, 07601
Research Site
Henderson, Nevada, 89052
Research Site
Hershey, Pennsylvania, 17033
Research Site
High Point, North Carolina, 27262
Research Site
Hilton Head Island, South Carolina, 29926
Research Site
Hollywood, Florida, 33021
Research Site
Houston, Texas, 77024
Research Site
Houston, Texas, 77030
Research Site
Hutchinson, Kansas, 67502
Research Site
Indianapolis, Indiana, 46260
Research Site
Jackson, Mississippi, 39202
Research Site
Jacksonville, Florida, 32256
Research Site
Jefferson City, Missouri, 65109
Research Site
Jonesboro, Arkansas, 72401
Research Site
La Verne, California, 91750
Research Site
Lancaster, California, 93534
Research Site
Lebanon, New Hampshire, 03756-0001
Research Site
Lincoln, Nebraska, 68510
Research Site
Long Beach, California, 90813
Research Site
Los Angeles, California, 90024
Research Site
Los Angeles, California, 90025
Research Site
Los Angeles, California, 90095-1772
Research Site
Melbourne, Florida, 32901
Research Site
Minneapolis, Minnesota, 55407
Research Site
Nashville, Tennessee, 37203
Research Site
New Haven, Connecticut, 06510
Research Site
New York, New York, 10003
Research Site
New York, New York, 10029
Research Site
New York, New York, 10032
Research Site
Niles, Illinois, 60714
Research Site
Northridge, California, 91328
Research Site
Nyack, New York, 10960
Research Site
Paducah, Kentucky, 42003
Research Site
Pawtucket, Rhode Island, 02860
Research Site
Pittsburgh, Pennsylvania, 15213
Research Site
Plano, Texas, 75075
Research Site
Redondo Beach, California, 90277
Research Site
Richlands, Virginia, 24641
Research Site
Richmond, Virginia, 23230
Research Site
Roanoke, Virginia, 24014
Research Site
Saint Louis Park, Minnesota, 55426
Research Site
San Antonio, Texas, 78217
Research Site
San Antonio, Texas, 78229
Research Site
Santa Barbara, California, 93105
Research Site
Santa Maria, California, 93454
Research Site
Seattle, Washington, 98109-1023
Research Site
Seattle, Washington, 98133
Research Site
Sioux Falls, South Dakota, 57105
Research Site
Tacoma, Washington, 98405
Research Site
Torrance, California, 90502
Research Site
Tucson, Arizona, 85724
Research Site
Tulsa, Oklahoma, 74136
Research Site
Tyler, Texas, 75702
Research Site
Wichita, Kansas, 67214

Other trials in United States

Japan28 sites

Research Site
Akashi-shi, Hyōgo, 673-8558
Research Site
Chuo-ku, Tokyo, 104-0045
Research Site
Fukuoka, Fukuoka, 811-1395
Research Site
Hidaka-Shi, Saitama, 350-1298
Research Site
Isehara-shi, Kanagawa, 259-1193
Research Site
Kagoshima, Kagoshima-ken, 892-0833
Research Site
Kitaadachi-gun, Saitama, 362-0806
Research Site
Kitakyushu-shi, Fukuoka, 802-0077
Research Site
Kumamoto, Kumamoto, 860-8556
Research Site
Kurashiki-shi, Okayama-ken, 701-0192
Research Site
Kure-shi, Hiroshima, 737-0023
Research Site
Kurume-shi, Fukuoka, 830-0013
Research Site
Kyoto, Kyoto, 606-8507
Research Site
Matsuyama, Ehime, 791-0280
Research Site
Miyazaki, Miyazaki, 880-0052
Research Site
Nagoya, Aichi-ken, 464-8681
Research Site
Nagoya, Aichi-ken, 467-8602
Research Site
Niigata, Niigata, 951-8566
Research Site
Osaka, Osaka, 537-8511
Research Site
Osaka, Osaka, 540-0006
Research Site
Shimotsuke-shi, Tochigi, 329-0498
Research Site
Suita-shi, Osaka, 565-0871
Research Site
Suntou-gun, Shizuoka, 411-8777
Research Site
Tokyo, 135-8550
Research Site
Tokyo, 142-8666
Research Site
Tokyo, 160-0023
Research Site
Tokyo, 173-0003
Research Site
Utsunomiya, Tochigi, 320-0834

Other trials in Japan

Spain24 sites

Research Site
A CoruÃ±a, Galicia, 15006
Research Site
A CoruÃ±a, Galicia, 15009
Research Site
AlcorcÃ³n, Madrid, 28922
Research Site
Badalona, CataluÃ±a, 08916
Research Site
Barcelona, CataluÃ±a, 08003
Research Site
Barcelona, CataluÃ±a, 08035
Research Site
Barcelona, CataluÃ±a, 08036
Research Site
Barcelona, CataluÃ±a, 08041
Research Site
CÃ¡diz, AndalucÃ-a, 11009
Research Site
CÃ³rdoba, AndalucÃ-a, 14004
Research Site
Elche, Valencia, 03203
Research Site
Girona, CataluÃ±a, 17007
Research Site
JaÃ©n, AndalucÃ-a, 23007
Research Site
Lleida, CataluÃ±a, 25198
Research Site
MÃ¡laga, AndalucÃ-a, 29010
Research Site
Madrid, 28009
Research Site
Madrid, 28040
Research Site
Madrid, 28050
Research Site
Sabadell, CataluÃ±a, 08208
Research Site
Santander, Cantabria, 39008
Research Site
Seville, AndalucÃ-a, 41013
Research Site
Valencia, Valencia, 46009
Research Site
Valencia, Valencia, 46010
Research Site
Zaragoza, AragÃ³n, 50009

Other trials in Spain

Canada22 sites

Research Site
Barrie, Ontario, L4M 6M2
Research Site
Brampton, Ontario, L6R 3J7
Research Site
Calgary, Alberta, T2N 4N2
Research Site
Edmonton, Alberta, T6G 1Z2
Research Site
Greater Sudbury, Ontario, P3E 5J1
Research Site
Greenfield Park, Quebec, J4V 2H1
Research Site
Kelowna, British Columbia, V1Y 5L3
Research Site
Kingston, Ontario, K7L 5P9
Research Site
Kitchener, Ontario, N2G 1G3
Research Site
Moncton, New Brunswick, E1C 6Z8
Research Site
Montreal, Quebec, H1T 2M4
Research Site
Montreal, Quebec, H2W 1T8
Research Site
Montreal, Quebec, H3T 1E2
Research Site
Ottawa, Ontario, K1H 8L6
Research Site
Québec, Quebec, G1S 4L8
Research Site
Sault Ste. Marie, Ontario, P6B 0A8
Research Site
Sherbrooke, Quebec, J1H 5N4
Research Site
St. John's, Newfoundland and Labrador, A1B 3V6
Research Site
Sydney, Nova Scotia, B1P 1P3
Research Site
Toronto, Ontario, M4C 3E7
Research Site
Toronto, Ontario, M9N 1N8
Research Site
Victoria, British Columbia, V8R 6V5

Other trials in Canada

Australia20 sites

Research Site
Bedford Park, South Australia, 5042
Research Site
Bentleigh East, Victoria, 3165
Research Site
Camperdown, New South Wales, 2050
Research Site
Caringbah, New South Wales, 2229
Research Site
East Melbourne, Victoria, 3002
Research Site
Fitzroy, Victoria, 3065
Research Site
Footscray, Victoria, 3011
Research Site
Frankston, Victoria, 3199
Research Site
Heidelberg, Victoria, 3084
Research Site
Kogarah, New South Wales, 2217
Research Site
Malvern, Victoria, 3144
Research Site
Parkville, Victoria, 3050
Research Site
Perth, Western Australia, 6000
Research Site
Richmond, Victoria, 3121
Research Site
Ringwood East, Victoria, 3135
Research Site
Subiaco, Western Australia, 6008
Research Site
Tweed Heads, New South Wales, 2485
Research Site
Wahroonga, New South Wales, 2076
Research Site
Warrnambool, Victoria, 3280
Research Site
Wodonga, Victoria, 3690

Other trials in Australia

Belgium20 sites

Research Site
Antwerp, 2020
Research Site
Bonheiden, 2820
Research Site
Bruges, 8000
Research Site
Brussels, 1020
Research Site
Brussels, 1090
Research Site
Brussels, 1200
Research Site
Edegem, 2650
Research Site
Ghent, 9000
Research Site
Hasselt, 3500
Research Site
Kortrijk, 8500
Research Site
Leuven, 3000
Research Site
LiÃ¨ge, 4000
Research Site
Libramont, 6800
Research Site
Namur, 5000
Research Site
Ostend, 8400
Research Site
Ottignies, 1340
Research Site
Sint-Niklaas, 9100
Research Site
Tournai, 7500
Research Site
Wilrijk, 2610
Research Site
Yvoir, 5530

Other trials in Belgium

United Kingdom19 sites

Research Site
Bebington, CH63 4JY
Research Site
Birmingham, B15 2TT
Research Site
Brighton, BN2 5BE
Research Site
Bristol, BS2 8ED
Research Site
Cambridge, CB2 0QQ
Research Site
Dorset, BH7 7DW
Research Site
Guildford, GU2 7XX
Research Site
Leeds, LS9 7TF
Research Site
London, SW3 6JJ
Research Site
London, W2 1NY
Research Site
Manchester, M20 4BX
Research Site
Manchester, M23 9LT
Research Site
Newcastle, NE4 6BE
Research Site
Peterborough, PE3 9GZ
Research Site
Plymouth, PL6 8DH
Research Site
Poole, BH15 2JB
Research Site
Portsmouth, PO6 3LY
Research Site
Sheffield, S10 2SJ
Research Site
Truro, TR1 3LJ

Other trials in United Kingdom

Germany16 sites

Research Site
Berlin, 10117
Research Site
Berlin, 10713
Research Site
Bonn, 53111
Research Site
Bottrop, 46236
Research Site
Erlangen, 91054
Research Site
Frankfurt, 60590
Research Site
Kiel, 24105
Research Site
Koblenz, 56068
Research Site
MÃ¼nchen, 80335
Research Site
MÃ¼nchen, 80638
Research Site
MÃ¼nchen, 81675
Research Site
Mannheim, 68161
Research Site
Recklinghausen, 45657
Research Site
Rostock, 18059
Research Site
TÃ¼bingen, 72076
Research Site
Trier, 54290

Other trials in Germany

Netherlands16 sites

Research Site
Amsterdam, 1066 CX
Research Site
Bergen op Zoom, 4624 VT
Research Site
Breda, 4819 EV
Research Site
Capelle aan den IJssel, 2906 ZC
Research Site
Dordrecht, 3318 AT
Research Site
Hoofddorp, 2134 TM
Research Site
Leiden, 2333 ZA
Research Site
Nieuwegein, 3435 CM
Research Site
Rotterdam, 3045 PM
Research Site
Rotterdam, 3075 EA
Research Site
Schiedam, 3118 JH
Research Site
Sittard-Geleen, 6162 BG
Research Site
The Hague, 2545 CH
Research Site
Tiel, 4002 WP
Research Site
Tilburg, 5022 GC
Research Site
Venlo, 5912 BL

Other trials in Netherlands

France14 sites

Research Site
Angers, 49933
Research Site
Bordeaux, 33030
Research Site
Dijon, 21079
Research Site
Grenoble, 38000
Research Site
HyÃ¨res, 83400
Research Site
Le Mans, 72000
Research Site
Lille, 59000
Research Site
Monaco, 98012
Research Site
Nantes, 44202
Research Site
Paris, 75012
Research Site
Pierre-Bénite, 69495
Research Site
Saint-Priest-en-Jarez, 42270
Research Site
Strasbourg, 67091
Research Site
Villejuif, 94805

Other trials in France

Hungary14 sites

Research Site
Budapest, 1032
Research Site
Budapest, 1062
Research Site
Budapest, 1082
Research Site
Budapest, 1122
Research Site
Budapest, 1125
Research Site
Budapest, 1145
Research Site
Debrecen, 4012
Research Site
Győr, 9023
Research Site
Nyíregyháza, 4400
Research Site
Pécs, 7624
Research Site
Szeged, 6725
Research Site
Székesfehérvár, 8000
Research Site
Szolnok, 5004
Research Site
Zalaegerszeg, 8900

Other trials in Hungary

Brazil13 sites

Research Site
Barretos, SÃ£o Paulo, 14784-400
Research Site
Curitiba, ParanÃ¡, 81520-060
Research Site
ItajaÃ-, Santa Catarina, 88301-220
Research Site
Londrina, ParanÃ¡, 86050-190
Research Site
Porto Alegre, Rio Grande do Sul, 90035-003
Research Site
Porto Alegre, Rio Grande do Sul, 90050-170
Research Site
Porto Alegre, Rio Grande do Sul, 90610-000
Research Site
SÃ£o Paulo, SÃ£o Paulo, 01246-000
Research Site
SÃ£o Paulo, SÃ£o Paulo, 01317-000
Research Site
Salvador, Estado de Bahia, 40950-640
Research Site
Salvador, Estado de Bahia, 41820-021
Research Site
Santo André, SÃ£o Paulo, 09080-110
Research Site
São Paulo, SÃ£o Paulo, 04038-034

Other trials in Brazil

India13 sites

Research Site
Ahilyanagar, Maharashtra, 413 736
Research Site
Bangalore, Karnataka, 560 054
Research Site
Chennai, Tamil Nadu, 600 018
Research Site
Chhatrapati Sambhajinagar, Maharashtra, 431 001
Research Site
Hyderabad, Andhra Pradesh, 500 024
Research Site
Jaipur, Rajasthan, 302 013
Research Site
Madurai, Tamil Nadu, 625 107
Research Site
Miraj, Maharashtra, 416 410
Research Site
Mumbai, Maharashtra, 400 012
Research Site
Mumbai, Maharashtra, 400 016
Research Site
Nashik, Maharashtra, 422 004
Research Site
Nashik, Maharashtra, 422 005
Research Site
Pune, Maharashtra, 411 001

Other trials in India

Mexico12 sites

Research Site
Colima, 28030
Research Site
Distrito Federal, 11000
Research Site
Durango, 34000
Research Site
León, Guanajuato, 37670
Research Site
Mexico City, Mexico City, 01120
Research Site
Mexico City, Mexico City, 06726
Research Site
Mexico City, Mexico City, 07760
Research Site
Monterrey, Nuevo LeÃ³n, 64000
Research Site
Pachuca, Hidalgo, 42084
Research Site
Querétaro, QuerÃ©taro, 76178
Research Site
San Luis Potosí City, San Luis PotosÃ-, 78200
Research Site
Toluca, 50180

Other trials in Mexico

Czechia11 sites

Research Site
Brno, 625 00
Research Site
Brno, 656 53
Research Site
Chomutov, 430 12
Research Site
Hořovice, 268 31
Research Site
Hradec Králové, 500 05
Research Site
Olomouc, 775 20
Research Site
Prague, 100 00
Research Site
Prague, 100 34
Research Site
Prague, 140 44
Research Site
Prague, 150 06
Research Site
Prague, 180 81

Other trials in Czechia

Italy11 sites

Research Site
Ancona, 60131
Research Site
Bari, 70124
Research Site
Brescia, 25123
Research Site
Meldola FC, 47014
Research Site
Milan, 20142
Research Site
Monza (MB), 20900
Research Site
Palermo, 90100
Research Site
Parma, 43100
Research Site
San Giovanni Rotondo FG, 71013
Research Site
Treviglio (BG), 24047
Research Site
Varese, 21100

Other trials in Italy

Israel9 sites

Research Site
Ashkelon, 78278
Research Site
Haifa, 31096
Research Site
Jerusalem, 91031
Research Site
Kfar Saba, 44281
Research Site
Petah Tikva, 49100
Research Site
Poria Eylit, 15208
Research Site
Rehovot, 76100
Research Site
Tel Aviv, 64239
Research Site
Tel Aviv, 69710

Other trials in Israel

Bulgaria7 sites

Research Site
Plovdiv, 4004
Research Site
Rousse, 7002
Research Site
Sofia, 1756
Research Site
Sofia, 1784
Research Site
Stara Zagora, 6003
Research Site
Varna, 9000
Research Site
Veliko Tarnovo, 5000

Other trials in Bulgaria

Poland7 sites

Research Site
Gdansk, 80-219
Research Site
Gdansk, 80-952
Research Site
Krakow, 31-108
Research Site
Olsztyn, 10-228
Research Site
Poznan, 61-485
Research Site
Rzeszów, 35-021
Research Site
Szczecin, 71-730

Other trials in Poland

Russia7 sites

Research Site
Barnaul, 656049
Research Site
Chelyabinsk, 454076
Research Site
Ivanovo, 153013
Research Site
Kazan', 420029
Research Site
Moscow, 115478
Research Site
Saint Petersburg, 195271
Research Site
Saint Petersburg, 197022

Other trials in Russia

Slovakia7 sites

Research Site
Bardejov, 085 01
Research Site
Košice, 041 91
Research Site
Michalovce, 071 01
Research Site
Poprad, 058 01
Research Site
Prešov, 080 01
Research Site
Spišská Nová Ves, 052 01
Research Site
Trebišov, 075 01

Other trials in Slovakia

South Africa7 sites

Research Site
Cape Town, 7925
Research Site
Groenkloof, Gauteng, 0181
Research Site
Johannesburg, Gauteng, 2196
Research Site
Pietermaritzburg, 3201
Research Site
Port Elizabeth, 6045
Research Site
Pretoria, 0002
Research Site
Pretoria, 0081

Other trials in South Africa

Argentina6 sites

Research Site
Neuquén, NeuquÃ©n, Q8300HDH
Research Site
Provincia de Santa Fe, Santa Fe Province, S3000FFV
Research Site
Quilmes, Buenos Aires, B1878DVB
Research Site
Quilmes, Buenos Aires, B1878GEG
Research Site
San Martín, Buenos Aires, B1650BOB
Research Site
San Miguel de Tucumán, Tucumán Province, T4000GTB

Other trials in Argentina

Greece6 sites

Research Site
Athens, 11522
Research Site
Athens, 11528
Research Site
Heraklion, 71110
Research Site
Pátrai, 26500
Research Site
Thessaloniki, 54636
Research Site
Thessaloniki, 56429

Other trials in Greece

Ireland6 sites

Research Site
Cork
Research Site
Dublin, 4
Research Site
Dublin, 8
Research Site
Dublin, 9
Research Site
Limerick
Research Site
Waterford

Other trials in Ireland

Philippines5 sites

Research Site
Cebu City, 6000
Research Site
Manila, 1000
Research Site
Manila, 1008
Research Site
Metro Manila, 1100
Research Site
Quezon City, 1102

Other trials in Philippines

Portugal5 sites

Research Site
Lisbon, 1099-023
Research Site
Lisbon, 1500-650
Research Site
Porto, 4200-072
Research Site
Porto, 4200-319
Research Site
Santa Maria da Feira, 4520-211

Other trials in Portugal

Romania5 sites

Research Site
Bucharest, 022328
Research Site
Craiova, 200385
Research Site
Sibiu, 550245
Research Site
Suceava, 720237
Research Site
Timișoara, 300239

Other trials in Romania

South Korea5 sites

Research Site
Goyang-si, Gyeonggi-do, 410-769
Research Site
Incheon, 405-835
Research Site
Seoul, 110-744
Research Site
Seoul, 120-752
Research Site
Seoul, 135-710

Other trials in South Korea

Denmark4 sites

Research Site
Ã…rhus C, 8000
Research Site
Herning, 7400
Research Site
Vejle, 7100
Research Site
Viborg, 8800

Other trials in Denmark

Malaysia4 sites

Research Site
Kota Bharu, Kelantan, 16150
Research Site
Kuala Lumpur, Kuala Lumpur, 50703
Research Site
Kuala Lumpur, Kuala Lumpur, 56000
Research Site
Subang Jaya, Selangor (incl. Putrajaya), 47500

Other trials in Malaysia

Taiwan4 sites

Research Site
Keelung, Keelung, 20401
Research Site
Putzu City, Chiayi, 61363
Research Site
Tainan, 704
Research Site
Taipei, 10002

Other trials in Taiwan

Turkey (Türkiye)4 sites

Research Site
Ä°zmir, 35340
Research Site
Ankara, 06100
Research Site
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About this study

Official 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)

Read the detailed description

Eligible participants were randomized in a 1:1 ratio to receive denosumab 120 mg or placebo subcutaneously (SC) for up to 5 years. Randomization was stratified based on:

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
Hormone receptor (estrogen receptor [ER]/progesterone receptor [PR]) status: ER and/or PR positive versus ER and PR negative
Human epidermal growth factor receptor 2 (HER-2) status: HER-2 positive versus HER-2 negative
Age: < 50 years versus ≥ 50 years
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: Breast Cancer
Being tested: Placebo, Denosumab
Keywords: Early Stage Breast Cancer, Bone Metastasis, Adjuvant treatment, Neoadjuvant treatment, Denosumab, Stage II breast cancer, Stage III breast cancer, Stage IIA breast cancer, Stage IIB breast cancer, Stage IIIA breast cancer, Stage IIIB breast cancer, Stage IIIC breast cancer, Early breast cancer, Breast Tumors, Breast Neoplasms
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Administered subcutaneously for up to 5 years
DenosumabDrug
Also called XGEVA®
Administered subcutaneously for up to 5 years

Study groups in NCT01077154
Study group	Role	What they receive
Placebo	Placebo comparator	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. Receives: Drug: Placebo
Denosumab	Experimental	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. Receives: Drug: Denosumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jun 201026 Mar 2018

First posted26 Feb 2010 (estimated)
Study start2 Jun 2010
Primary completion31 Aug 2017
Study completion26 Mar 2018

Why it stopped: Terminated: Amgen decision following Primary Analysis. Not due to safety reason

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 4,509 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01077154
Sponsor's protocol ID: 20060359
Other IDs: 2009-011299-32, 2009
Status last verified: Sep 2021
First submitted: 4 Feb 2010
Last updated: 28 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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.
PubMed 31806543
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.
PubMed 34185259
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.
PubMed 38979716

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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)
ClinicalTrials.gov ID: NCT01077154
Acronym / sponsor ID: 20060359
Conditions: Breast Cancer
Keywords: Early Stage Breast Cancer, Bone Metastasis, Adjuvant treatment, Neoadjuvant treatment, Denosumab, Stage II breast cancer, Stage III breast cancer, Stage IIA breast cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated: Amgen decision following Primary Analysis. Not due to safety reason
Enrolment: 4,509 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Collaborators: Daiichi Sankyo
Study start: 2 Jun 2010 (actual)
Primary completion: 31 Aug 2017 (actual)
Study completion: 26 Mar 2018 (actual)
First posted: 26 Feb 2010 (estimated)
Results: Posted 3 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Eligible participants were randomized in a 1:1 ratio to receive denosumab 120 mg or placebo subcutaneously (SC) for up to 5 years. Randomization was stratified based on:

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
Hormone receptor (estrogen receptor [ER]/progesterone receptor [PR]) status: ER and/or PR positive versus ER and PR negative
Human epidermal growth factor receptor 2 (HER-2) status: HER-2 positive versus HER-2 negative
Age: < 50 years versus ≥ 50 years
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants 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	Experimental	Drug: DenosumabParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

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:
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:

Key exclusion criteria (19 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboAdministered subcutaneously for up to 5 years	Drug	Placebo
DenosumabAlso: XGEVA®Administered subcutaneously for up to 5 years	Drug	Denosumab

Primary outcome

Bone Metastasis-free Survival (BMFS)
Time frame: 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.
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.

4 secondary outcomes

Disease-free Survival (DFS)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 3 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	2,253	27
Denosumab	2,256	28

Primary outcome: Bone Metastasis-free Survival (BMFS)

Time frame: 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.. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Placebo n = 2253	Denosumab n = 2256
Value	13.5 (12.1 to 15.0)	12.9 (11.6 to 14.3)

Placebo vs Denosumab: Hazard Ratio (HR): 0.97 (95% CI 0.82 to 1.14), p = 0.70, Stratified Log Rank

Population analysed: All randomized participants

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality includes deaths from first dose of study drug to the end of study date; median (min, max) time on study was 72.7 (0, 92) and 72.3 (0, 92) months for Placebo/Denosumab respectively. Adverse Events are from first dose of study drug to 30 days after last dose; median (min, max) time on treatment was 59.4 (0.7, 67) and 59.3 (0.7, 67) months for Placebo/Denosumab respectively.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	675 of 2,218 (30.4%)	2,123 of 2,218 (95.7%)	215 of 2,218
Denosumab	702 of 2,241 (31.3%)	2,149 of 2,241 (95.9%)	215 of 2,241

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31806543Coleman 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.
Background: PubMed 34185259Coleman 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.
Derived from this study: PubMed 38979716Adams 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.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

459 sites in 39 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Denosumab in people with Breast Cancer, run by Amgen at 459 sites in 39 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 459 sites in United States, Japan, Spain, Canada, Australia and 34 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone Metastasis-free Survival (BMFS) (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01077154, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.