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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01077154
First received: February 4, 2010
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

Rationale: For women with early-stage breast cancer, bone is a frequent site of relapse, and most women with advanced breast cancer will eventually develop disease in the bone.

Denosumab, a fully human monoclonal antibody that specifically inhibits RANK ligand, may have the potential to interrupt the hypothetical "vicious cycle" of cancer-induced bone destruction and tumor cell expansion through the bone. It is not yet known if denosumab may prevent disease recurrence in the bone or in any other part of the body.

Purpose: 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.


Condition Intervention Phase
Breast Cancer
Drug: Placebo
Drug: Denosumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Bone metastasis-free survival [ Time Frame: 6 years, 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 6 years, 3 months ] [ Designated as safety issue: No ]
  • Distant recurrence-free survival [ Time Frame: 6 years, 3 months ] [ Designated as safety issue: No ]
  • Safety and tolerability of denosumab [ Time Frame: 6 years, 3 months ] [ Designated as safety issue: Yes ]
  • Disease-free survival [ Time Frame: 6 years, 3 months ] [ Designated as safety issue: No ]

Enrollment: 4509
Study Start Date: May 2010
Estimated Study Completion Date: October 2021
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Denosumab
Patients will receive denosumab as a subcutaneous injection (under the skin), and will take daily calcium and vitamin D supplementation, for up to 5 years.
Drug: Denosumab
120mg subcutaneously (SC) once monthly for 6 months. 120mg SC every 3 months for the next 4 and a half years. Oral calcium (at least 500 mg) and vitamin D (at least 400 IU) for 5 years.
Placebo Comparator: Placebo
Patients will receive placebo as a subcutaneous injection (under the skin), and will take daily calcium and vitamin D supplementation, for up to 5 years.
Drug: Placebo
120mg SC once monthly for the first 6 months. 120mg SC every 3 months for the next 4 and a half years. Oral calcium (at least 500 mg) and vitamin D (at least 400 IU) for 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed, 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 > 5cm (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

  • For subjects receiving adjuvant therapy only, time between definitive surgery and randomization must be ≤ 12 weeks. Definitive surgery may include secondary interventions (e.g. to clear inadequate surgical margins)
  • For subjects receiving adjuvant therapy only, 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
  • For subjects receiving adjuvant therapy only, 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
  • For subjects receiving neoadjuvant therapy only, 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:

  • Prior or current evidence of any metastatic involvement of any distant site
  • History of breast cancer (other than ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS]) prior to the current diagnosis
  • Osteoporosis requiring treatment at the time of randomization or treatment considered likely to become necessary within the subsequent six months
  • Any prior or synchronous malignancy (other than breast cancer), except i) Malignancy treated with curative intent and with no evidence of disease for ≥ 5 years prior to enrollment and considered to be at low risk for recurrence by the treating physician ii) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Active infection with Hepatitis B virus or Hepatitis C virus
  • Known infection with human immunodeficiency virus (HIV)
  • Prior history or current evidence of osteomyelitis/osteonecrosis of the jaw
  • Active dental or jaw condition which requires oral surgery
  • Planned invasive dental procedure for the course of the study
  • Non-healed dental or oral surgery
  • Use of oral bisphosphonates within the past 1 year
  • Prior or current IV bisphosphonate administration
  • Prior administration of denosumab
  • Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or investigational drug study(s), or subject is receiving other investigational agent(s)
  • Subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment.
  • Subject is of child bearing potential and is not willing to use, in combination with her partner, 2 highly effective methods of contraception or abstinence during treatment and for 7 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 may prevent the subject from completing the study or interfere with the interpretation of the study results
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01077154

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Pachuca de Soto, Hidalgo, Mexico, 42084
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Monterrey, Nuevo León, Mexico, 64000
Research Site
Queretaro, Querétaro, Mexico, 76178
Research Site
San Luis Potosi, San Luis PotosÃ-, Mexico, 78200
Research Site
Colima, Mexico, 28030
Research Site
Distrito Federal, Mexico, 11000
Research Site
Durango, Mexico, 34000
Research Site
Toluca, Mexico, 50180
Netherlands
Research Site
Amsterdam, Netherlands, 1066 CX
Research Site
Bergen op Zoom, Netherlands, 4624 VT
Research Site
Breda, Netherlands, 4819 EV
Research Site
Capelle aan den ijssel, Netherlands, 2906 ZC
Research Site
Den Haag, Netherlands, 2545 CH
Research Site
Dordrecht, Netherlands, 3318 AT
Research Site
Hoofddorp, Netherlands, 2134 TM
Research Site
Leiden, Netherlands, 2333 ZA
Research Site
Nieuwegein, Netherlands, 3435 CM
Research Site
Rotterdam, Netherlands, 3075 EA
Research Site
Rotterdam, Netherlands, 3045 PM
Research Site
Schiedam, Netherlands, 3118 JH
Research Site
Sittard-Geleen, Netherlands, 6162 BG
Research Site
Tiel, Netherlands, 4002 WP
Research Site
Tilburg, Netherlands, 5022 GC
Research Site
Venlo, Netherlands, 5912 BL
Peru
Research Site
Lima, Peru, Lima 11
Research Site
Lima, Peru, Lima 27
Research Site
Lima, Peru, Lima 18
Philippines
Research Site
Cebu City, Philippines, 6000
Research Site
Manila, Philippines, 1000
Research Site
Manila, Philippines, 1008
Research Site
Metro Manila, Philippines, 1100
Research Site
Quezon City, Philippines, 1102
Poland
Research Site
Gdansk, Poland, 80-219
Research Site
Gdansk, Poland, 80-952
Research Site
Krakow, Poland, 31-108
Research Site
Olsztyn, Poland, 10-228
Research Site
Poznan, Poland, 61-485
Research Site
Rzeszow, Poland, 35-021
Research Site
Szczecin, Poland, 71-730
Portugal
Research Site
Lisboa, Portugal, 1099-023
Research Site
Lisboa, Portugal, 1500-650
Research Site
Porto, Portugal, 4200-072
Research Site
Porto, Portugal, 4200-319
Research Site
Santa Maria da Feira, Portugal, 4520-211
Romania
Research Site
Bucharest, Romania, 022328
Research Site
Craiova, Romania, 200385
Research Site
Sibiu, Romania, 550245
Research Site
Suceava, Romania, 720237
Research Site
Timisoara, Romania, 300239
Russian Federation
Research Site
Barnaul, Russian Federation, 656049
Research Site
Chelyabinsk, Russian Federation, 454076
Research Site
Ivanovo, Russian Federation, 153013
Research Site
Kazan, Russian Federation, 420029
Research Site
Moscow, Russian Federation, 115478
Research Site
Saint Petersburg, Russian Federation, 197022
Research Site
Saint Petersburg, Russian Federation, 195271
Serbia
Research Site
Belgrade, Serbia, 11000
Research Site
Nis, Serbia, 18000
Slovakia
Research Site
Bardejov, Slovakia, 085 01
Research Site
Kosice, Slovakia, 041 91
Research Site
Michalovce, Slovakia, 071 01
Research Site
Poprad, Slovakia, 058 01
Research Site
Presov, Slovakia, 080 01
Research Site
Spisska Nova Ves, Slovakia, 052 01
Research Site
Trebisov, Slovakia, 075 01
Slovenia
Research Site
Ljublijana, Slovenia, 1525
Research Site
Maribor, Slovenia, 2000
South Africa
Research Site
Groenkloof, Gauteng, South Africa, 0181
Research Site
Johannesburg, Gauteng, South Africa, 2196
Research Site
Cape Town, South Africa, 7925
Research Site
Pietermaritzburg, South Africa, 3201
Research Site
Port Elizabeth, South Africa, 6045
Research Site
Pretoria, South Africa, 0002
Research Site
Pretoria, South Africa, 0081
Spain
Research Site
Cádiz, AndalucÃ-a, Spain, 11009
Research Site
Córdoba, AndalucÃ-a, Spain, 14004
Research Site
Jaén, AndalucÃ-a, Spain, 23007
Research Site
Málaga, AndalucÃ-a, Spain, 29010
Research Site
Sevilla, AndalucÃ-a, Spain, 41013
Research Site
Zaragoza, Aragón, Spain, 50009
Research Site
Santander, Cantabria, Spain, 39008
Research Site
Badalona, Cataluña, Spain, 08916
Research Site
Barcelona, Cataluña, Spain, 08003
Research Site
Barcelona, Cataluña, Spain, 08035
Research Site
Barcelona, Cataluña, Spain, 08036
Research Site
Barcelona, Cataluña, Spain, 08041
Research Site
Girona, Cataluña, Spain, 17007
Research Site
Lleida, Cataluña, Spain, 25198
Research Site
Sabadell, Cataluña, Spain, 08208
Research Site
Elche, Comunidad Valenciana, Spain, 03203
Research Site
Valencia, Comunidad Valenciana, Spain, 46009
Research Site
Valencia, Comunidad Valenciana, Spain, 46010
Research Site
A Coruña, Galicia, Spain, 15006
Research Site
A Coruña, Galicia, Spain, 15009
Research Site
Alcorcón, Madrid, Spain, 28922
Research Site
Madrid, Spain, 28009
Research Site
Madrid, Spain, 28040
Research Site
Madrid, Spain, 28050
Taiwan
Research Site
Putzu City, Chiayi, Taiwan, 61363
Research Site
Keelung City, Keelung, Taiwan, 20401
Research Site
Tainan, Taiwan, 704
Research Site
Taipei, Taiwan, 10002
Turkey
Research Site
Ankara, Turkey, 06500
Research Site
Ankara, Turkey, 06100
Research Site
Bornova-Izmir, Turkey, 35100
Research Site
Ä°zmir, Turkey, 35340
United Kingdom
Research Site
Bebington, United Kingdom, CH63 4JY
Research Site
Birmingham, United Kingdom, B15 2TT
Research Site
Brighton, United Kingdom, BN2 5BE
Research Site
Bristol, United Kingdom, BS2 8ED
Research Site
Cambridge, United Kingdom, CB2 0QQ
Research Site
Dorset, United Kingdom, BH7 7DW
Research Site
Guildford, United Kingdom, GU2 7XX
Research Site
Leeds, United Kingdom, LS9 7TF
Research Site
London, United Kingdom, W2 1NY
Research Site
London, United Kingdom, SW3 6JJ
Research Site
Manchester, United Kingdom, M20 4BX
Research Site
Manchester, United Kingdom, M23 9LT
Research Site
Newcastle, United Kingdom, NE4 6BE
Research Site
Peterborough, United Kingdom, PE3 9GZ
Research Site
Plymouth, United Kingdom, PL6 8DH
Research Site
Poole, United Kingdom, BH15 2JB
Research Site
Portsmouth, United Kingdom, PO6 3LY
Research Site
Sheffield, United Kingdom, S10 2SJ
Research Site
Truro, United Kingdom, TR1 3LJ
Sponsors and Collaborators
Amgen
Daiichi Sankyo Inc.
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01077154     History of Changes
Other Study ID Numbers: 20060359
Study First Received: February 4, 2010
Last Updated: January 7, 2014
Health Authority: Mexico: Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
Peru: INS (Instituto Nacional de Salud)
Phillippines: the Bureau of Food and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED)
Romania: National Medicines Agency
Russia: Federal Service for Surveillance in the field of Healthcare and Social Development (a body of the Ministry of Health)
Serbia: Medicine and Medical Devices Agency of Serbia
Slovakia: Štátny ústav pre kontrolu lieciv
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration
Taiwan: Department of Health
Latvia: State Agency of Medicines
Malaysia: National Pharmaceutical Control Bureau
Turkey: The Ministry of Health of the Republic of Turkey
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Argentina: ANMAT (Administracion Nacional de Medicamentos Alimentos y Tecnologia Medica)
Australia: Therapeutic Goods Administration
Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement
Brazil: ANVISA (Agência Nacional de Vigilância Sanitária)
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Chile: Instituto De Salud Pública de Chile (ISP)
China: Food and Drug Administration
Czech Republic: Statni ustav pro kontrolu leciv
Denmark: Laegemiddelstyrelsen
European Union: EMEA
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Greece: Ministry of Health & Social Solidarity, National Organization for Medicines
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Israel: Ministry of Health
Italy: Local Ethics Committees

Keywords provided by Amgen:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 22, 2014