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

Primary Purpose

Breast Cancer

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo

Denosumab

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed, American Joint Committee on Cancer (AJCC) stage II or III breast cancer
High risk of breast cancer recurrence, defined as documented evidence of one or more of the following criteria:
i) Biopsy evidence of breast cancer in regional lymph node(s) (LN) (node-positive disease); Nodal micrometastases only are not considered node positive ii) Tumor size > 5 cm (T3) or locally advanced disease (T4)
Documented pathological evaluation of the breast cancer for hormone receptor (estrogen receptor [ER] and progesterone receptor [PR]) status and HER-2 status
Subjects must be receiving or be scheduled to receive standard of care systemic adjuvant or neoadjuvant chemotherapy and/or endocrine therapy and/or HER-2 targeted therapy
For subjects receiving adjuvant therapy only:
subjects must have undergone complete resection of the primary tumor with clean surgical margins, or subjects must have undergone resection of the primary tumor and be scheduled for further treatment of the primary tumor with curative intent. Definitive treatment must be planned to be completed within approximately 9 months of randomization
Time between definitive surgery and randomization must be ≤ 12 weeks. Definitive surgery may include secondary interventions (e.g. to clear inadequate surgical margins)
Subjects with node positive disease must have undergone treatment of axillary LN with curative intent, or subjects must be scheduled for further treatment of regional lymph nodes with curative intent. Definitive treatment must be planned to be completed within approximately 9 months of randomization
Subjects must not have received prior neoadjuvant treatment. Endocrine treatment for less than 30 days prior to surgery is not considered prior neoadjuvant treatment
For subjects receiving neoadjuvant therapy only:
Time between start of neoadjuvant treatment and randomization must be ≤ 8 weeks and subjects must be scheduled to undergo definitive treatment (including surgery and/or radiotherapy) with curative intent within approximately 9 months of starting neoadjuvant treatment
Female subjects with age ≥ 18 years
Subjects with reproductive potential must have a negative pregnancy test within 14 days before randomization
Serum calcium or albumin-adjusted serum calcium ≥ 2.0 mmol/L (8.0 mg/dL) and ≤ 2.9 mmol/L (11.5 mg/dL)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Written informed consent before any study-specific procedure is performed

Exclusion Criteria:

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Denosumab

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT01077154

First Posted

February 4, 2010

Last Updated

September 1, 2021

Sponsor

Amgen

Collaborators

Daiichi Sankyo, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01077154

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Terminated

Why Stopped

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

Study Start Date

June 2, 2010 (Actual)

Primary Completion Date

August 31, 2017 (Actual)

Study Completion Date

March 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

Collaborators

Daiichi Sankyo, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This randomized phase 3 trial is studying the effect of denosumab to see if it can prevent disease recurrence in the bone or in any other part of the body, when it is given as adjuvant therapy for women with early-stage breast cancer, who are at high risk of disease recurrence.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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, Stage IIB breast cancer, Stage IIIA breast cancer, Stage IIIB breast cancer, Stage IIIC breast cancer, Early breast cancer, Breast Tumors, Breast Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

4509 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Denosumab

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered subcutaneously for up to 5 years

Intervention Type

Drug

Intervention Name(s)

Denosumab

Other Intervention Name(s)

XGEVA®

Intervention Description

Administered subcutaneously for up to 5 years

Primary Outcome Measure Information:

Title

Bone Metastasis-free Survival (BMFS)

Description

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.

Secondary Outcome Measure Information:

Title

Disease-free Survival (DFS)

Description

Time Frame

Title

Disease-free Survival (DFS) in the Postmenopausal Subset

Description

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.

Time Frame

Title

Overall Survival

Description

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.

Title

Distant Recurrence-free Survival

Description

Time Frame

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed, American Joint Committee on Cancer (AJCC) stage II or III breast cancer High risk of breast cancer recurrence, defined as documented evidence of one or more of the following criteria: i) Biopsy evidence of breast cancer in regional lymph node(s) (LN) (node-positive disease); Nodal micrometastases only are not considered node positive ii) Tumor size > 5 cm (T3) or locally advanced disease (T4) Documented pathological evaluation of the breast cancer for hormone receptor (estrogen receptor [ER] and progesterone receptor [PR]) status and HER-2 status Subjects must be receiving or be scheduled to receive standard of care systemic adjuvant or neoadjuvant chemotherapy and/or endocrine therapy and/or HER-2 targeted therapy For subjects receiving adjuvant therapy only: subjects must have undergone complete resection of the primary tumor with clean surgical margins, or subjects must have undergone resection of the primary tumor and be scheduled for further treatment of the primary tumor with curative intent. Definitive treatment must be planned to be completed within approximately 9 months of randomization Time between definitive surgery and randomization must be ≤ 12 weeks. Definitive surgery may include secondary interventions (e.g. to clear inadequate surgical margins) Subjects with node positive disease must have undergone treatment of axillary LN with curative intent, or subjects must be scheduled for further treatment of regional lymph nodes with curative intent. Definitive treatment must be planned to be completed within approximately 9 months of randomization Subjects must not have received prior neoadjuvant treatment. Endocrine treatment for less than 30 days prior to surgery is not considered prior neoadjuvant treatment For subjects receiving neoadjuvant therapy only: Time between start of neoadjuvant treatment and randomization must be ≤ 8 weeks and subjects must be scheduled to undergo definitive treatment (including surgery and/or radiotherapy) with curative intent within approximately 9 months of starting neoadjuvant treatment Female subjects with age ≥ 18 years Subjects with reproductive potential must have a negative pregnancy test within 14 days before randomization Serum calcium or albumin-adjusted serum calcium ≥ 2.0 mmol/L (8.0 mg/dL) and ≤ 2.9 mmol/L (11.5 mg/dL) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Written informed consent before any study-specific procedure is performed Exclusion Criteria: Prior or current evidence of any metastatic involvement of any distant site History of breast cancer (other than ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS]) prior to the current diagnosis Osteoporosis requiring treatment at the time of randomization or treatment considered likely to become necessary within the subsequent six months Any prior or synchronous malignancy (other than breast cancer), except i) Malignancy treated with curative intent and with no evidence of disease for ≥ 5 years prior to enrollment and considered to be at low risk for recurrence by the treating physician ii) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease Active infection with Hepatitis B virus or Hepatitis C virus Known infection with human immunodeficiency virus (HIV) Prior history or current evidence of osteomyelitis/osteonecrosis of the jaw Active dental or jaw condition which requires oral surgery Planned invasive dental procedure for the course of the study Non-healed dental or oral surgery Use of oral bisphosphonates within the past 1 year Prior or current IV bisphosphonate administration Prior administration of denosumab Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or investigational drug study(s), or subject is receiving other investigational agent(s) Subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment. Subject is of child bearing potential and is not willing to use, in combination with her partner, 2 highly effective methods of contraception or abstinence during treatment and for 5 months after the end of treatment Subject has known sensitivity to any of the products to be administered during the study (e.g., mammalian derived products, calcium, or vitamin D) Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures. Any major medical or psychiatric disorder that in the opinion of the investigator prevent the subject from completing the study or interfere with the interpretation of the study results

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Research Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

Research Site

City

Jonesboro

State/Province

Arkansas

ZIP/Postal Code

72401

Country

United States

Facility Name

Research Site

City

Alhambra

State/Province

California

ZIP/Postal Code

91801

Country

United States

Facility Name

Research Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Research Site

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Research Site

City

Campbell

State/Province

California

ZIP/Postal Code

95008

Country

United States

Facility Name

Research Site

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Research Site

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Research Site

City

La Verne

State/Province

California

ZIP/Postal Code

91750

Country

United States

Facility Name

Research Site

City

Lancaster

State/Province

California

ZIP/Postal Code

93534

Country

United States

Facility Name

Research Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90813

Country

United States

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90024

Country

United States

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095-1772

Country

United States

Facility Name

Research Site

City

Northridge

State/Province

California

ZIP/Postal Code

91328

Country

United States

Facility Name

Research Site

City

Redondo Beach

State/Province

California

ZIP/Postal Code

90277

Country

United States

Facility Name

Research Site

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93105

Country

United States

Facility Name

Research Site

City

Santa Maria

State/Province

California

ZIP/Postal Code

93454

Country

United States

Facility Name

Research Site

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

Facility Name

Research Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80220

Country

United States

Facility Name

Research Site

City

Grand Junction

State/Province

Colorado

ZIP/Postal Code

81501

Country

United States

Facility Name

Research Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

Research Site

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33435

Country

United States

Facility Name

Research Site

City

Coral Springs

State/Province

Florida

ZIP/Postal Code

33065

Country

United States

Facility Name

Research Site

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33316

Country

United States

Facility Name

Research Site

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Research Site

City

Melbourne

State/Province

Florida

ZIP/Postal Code

32901

Country

United States

Facility Name

Research Site

City

Athens

State/Province

Georgia

ZIP/Postal Code

30607

Country

United States

Facility Name

Research Site

City

Niles

State/Province

Illinois

ZIP/Postal Code

60714

Country

United States

Facility Name

Research Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Research Site

City

Cedar Rapids

State/Province

Iowa

ZIP/Postal Code

52402

Country

United States

Facility Name

Research Site

City

Hutchinson

State/Province

Kansas

ZIP/Postal Code

67502

Country

United States

Facility Name

Research Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Research Site

City

Paducah

State/Province

Kentucky

ZIP/Postal Code

42003

Country

United States

Facility Name

Research Site

City

Annapolis

State/Province

Maryland

ZIP/Postal Code

21401

Country

United States

Facility Name

Research Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Research Site

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20817

Country

United States

Facility Name

Research Site

City

Columbia

State/Province

Maryland

ZIP/Postal Code

21044

Country

United States

Facility Name

Research Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Research Site

City

Danvers

State/Province

Massachusetts

ZIP/Postal Code

01923

Country

United States

Facility Name

Research Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Research Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Research Site

City

Edina

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

Facility Name

Research Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55407

Country

United States

Facility Name

Research Site

City

Saint Louis Park

State/Province

Minnesota

ZIP/Postal Code

55426

Country

United States

Facility Name

Research Site

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39202

Country

United States

Facility Name

Research Site

City

Jefferson City

State/Province

Missouri

ZIP/Postal Code

65109

Country

United States

Facility Name

Research Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68510

Country

United States

Facility Name

Research Site

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89052

Country

United States

Facility Name

Research Site

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756-0001

Country

United States

Facility Name

Research Site

City

Denville

State/Province

New Jersey

ZIP/Postal Code

07834

Country

United States

Facility Name

Research Site

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

Research Site

City

East Setauket

State/Province

New York

ZIP/Postal Code

11733

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Research Site

City

Nyack

State/Province

New York

ZIP/Postal Code

10960

Country

United States

Facility Name

Research Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28806

Country

United States

Facility Name

Research Site

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Research Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Research Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Research Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Research Site

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

Research Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Research Site

City

Pawtucket

State/Province

Rhode Island

ZIP/Postal Code

02860

Country

United States

Facility Name

Research Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29414

Country

United States

Facility Name

Research Site

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29210

Country

United States

Facility Name

Research Site

City

Hilton Head Island

State/Province

South Carolina

ZIP/Postal Code

29926

Country

United States

Facility Name

Research Site

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57105

Country

United States

Facility Name

Research Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Research Site

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Research Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Research Site

City

Abilene

State/Province

Texas

ZIP/Postal Code

79606-5208

Country

United States

Facility Name

Research Site

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78463

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230-2510

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Research Site

City

El Paso

State/Province

Texas

ZIP/Postal Code

79902

Country

United States

Facility Name

Research Site

City

Garland

State/Province

Texas

ZIP/Postal Code

75042

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77024

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Research Site

City

Plano

State/Province

Texas

ZIP/Postal Code

75075

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Research Site

City

Tyler

State/Province

Texas

ZIP/Postal Code

75702

Country

United States

Facility Name

Research Site

City

Richlands

State/Province

Virginia

ZIP/Postal Code

24641

Country

United States

Facility Name

Research Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23230

Country

United States

Facility Name

Research Site

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24014

Country

United States

Facility Name

Research Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109-1023

Country

United States

Facility Name

Research Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98133

Country

United States

Facility Name

Research Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Research Site

City

Quilmes

State/Province

Buenos Aires

ZIP/Postal Code

B1878DVB

Country

Argentina

Facility Name

Research Site

City

Quilmes

State/Province

Buenos Aires

ZIP/Postal Code

B1878GEG

Country

Argentina

Facility Name

Research Site

City

San Martin

State/Province

Buenos Aires

ZIP/Postal Code

B1650BOB

Country

Argentina

Facility Name

Research Site

City

Neuquen

State/Province

NeuquÃ©n

ZIP/Postal Code

Q8300HDH

Country

Argentina

Facility Name

Research Site

City

Provincia De Santa Fe

State/Province

Santa Fe

ZIP/Postal Code

S3000FFV

Country

Argentina

Facility Name

Research Site

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

T4000GTB

Country

Argentina

Facility Name

Research Site

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

Research Site

City

Caringbah

State/Province

New South Wales

ZIP/Postal Code

2229

Country

Australia

Facility Name

Research Site

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Research Site

City

Tweed Heads

State/Province

New South Wales

ZIP/Postal Code

2485

Country

Australia

Facility Name

Research Site

City

Wahroonga

State/Province

New South Wales

ZIP/Postal Code

2076

Country

Australia

Facility Name

Research Site

City

Bedford Park

State/Province

South Australia

ZIP/Postal Code

5042

Country

Australia

Facility Name

Research Site

City

Bentleigh East

State/Province

Victoria

ZIP/Postal Code

3165

Country

Australia

Facility Name

Research Site

City

East Melbourne

State/Province

Victoria

ZIP/Postal Code

3002

Country

Australia

Facility Name

Research Site

City

Fitzroy

State/Province

Victoria

ZIP/Postal Code

3065

Country

Australia

Facility Name

Research Site

City

Footscray

State/Province

Victoria

ZIP/Postal Code

3011

Country

Australia

Facility Name

Research Site

City

Frankston

State/Province

Victoria

ZIP/Postal Code

3199

Country

Australia

Facility Name

Research Site

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

Research Site

City

Malvern

State/Province

Victoria

ZIP/Postal Code

3144

Country

Australia

Facility Name

Research Site

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Research Site

City

Richmond

State/Province

Victoria

ZIP/Postal Code

3121

Country

Australia

Facility Name

Research Site

City

Ringwood East

State/Province

Victoria

ZIP/Postal Code

3135

Country

Australia

Facility Name

Research Site

City

Warrnambool

State/Province

Victoria

ZIP/Postal Code

3280

Country

Australia

Facility Name

Research Site

City

Wodonga

State/Province

Victoria

ZIP/Postal Code

3690

Country

Australia

Facility Name

Research Site

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6000

Country

Australia

Facility Name

Research Site

City

Subiaco

State/Province

Western Australia

ZIP/Postal Code

6008

Country

Australia

Facility Name

Research Site

City

Antwerpen

ZIP/Postal Code

2020

Country

Belgium

Facility Name

Research Site

City

Bonheiden

ZIP/Postal Code

2820

Country

Belgium

Facility Name

Research Site

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

Research Site

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Research Site

City

Bruxelles

ZIP/Postal Code

1020

Country

Belgium

Facility Name

Research Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Research Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Research Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Research Site

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Research Site

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

Research Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Research Site

City

Libramont

ZIP/Postal Code

6800

Country

Belgium

Facility Name

Research Site

City

LiÃ¨ge

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Research Site

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Facility Name

Research Site

City

Oostende

ZIP/Postal Code

8400

Country

Belgium

Facility Name

Research Site

City

Ottignies

ZIP/Postal Code

1340

Country

Belgium

Facility Name

Research Site

City

Sint-Niklaas

ZIP/Postal Code

9100

Country

Belgium

Facility Name

Research Site

City

Tournai

ZIP/Postal Code

7500

Country

Belgium

Facility Name

Research Site

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

Facility Name

Research Site

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

Research Site

City

Salvador

State/Province

Bahia

ZIP/Postal Code

40950-640

Country

Brazil

Facility Name

Research Site

City

Salvador

State/Province

Bahia

ZIP/Postal Code

41820-021

Country

Brazil

Facility Name

Research Site

City

Curitiba

State/Province

ParanÃ¡

ZIP/Postal Code

81520-060

Country

Brazil

Facility Name

Research Site

City

Londrina

State/Province

ParanÃ¡

ZIP/Postal Code

86050-190

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-003

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90050-170

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Research Site

City

ItajaÃ-

State/Province

Santa Catarina

ZIP/Postal Code

88301-220

Country

Brazil

Facility Name

Research Site

City

Barretos

State/Province

SÃ£o Paulo

ZIP/Postal Code

14784-400

Country

Brazil

Facility Name

Research Site

City

Santo Andre

State/Province

SÃ£o Paulo

ZIP/Postal Code

09080-110

Country

Brazil

Facility Name

Research Site

City

Sao Paulo

State/Province

SÃ£o Paulo

ZIP/Postal Code

04038-034

Country

Brazil

Facility Name

Research Site

City

SÃ£o Paulo

ZIP/Postal Code

01246-000

Country

Brazil

Facility Name

Research Site

City

SÃ£o Paulo

ZIP/Postal Code

01317-000

Country

Brazil

Facility Name

Research Site

City

Plovdiv

ZIP/Postal Code

4004

Country

Bulgaria

Facility Name

Research Site

City

Rousse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1756

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

Research Site

City

Stara Zagora

ZIP/Postal Code

6003

Country

Bulgaria

Facility Name

Research Site

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Research Site

City

Veliko Tarnovo

ZIP/Postal Code

5000

Country

Bulgaria

Facility Name

Research Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

Research Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Research Site

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y 5L3

Country

Canada

Facility Name

Research Site

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8R 6V5

Country

Canada

Facility Name

Research Site

City

Moncton

State/Province

New Brunswick

ZIP/Postal Code

E1C 6Z8

Country

Canada

Facility Name

Research Site

City

St. John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1B 3V6

Country

Canada

Facility Name

Research Site

City

Sydney

State/Province

Nova Scotia

ZIP/Postal Code

B1P 1P3

Country

Canada

Facility Name

Research Site

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 6M2

Country

Canada

Facility Name

Research Site

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6R 3J7

Country

Canada

Facility Name

Research Site

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 5P9

Country

Canada

Facility Name

Research Site

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2G 1G3

Country

Canada

Facility Name

Research Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Research Site

City

Sault Ste. Marie

State/Province

Ontario

ZIP/Postal Code

P6B 0A8

Country

Canada

Facility Name

Research Site

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3E 5J1

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4C 3E7

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9N 1N8

Country

Canada

Facility Name

Research Site

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2H1

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1T8

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

Research Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Research Site

City

Quebec

ZIP/Postal Code

G1S 4L8

Country

Canada

Facility Name

Research Site

City

Temuco

State/Province

CautÃ-n

ZIP/Postal Code

4810469

Country

Chile

Facility Name

Research Site

City

Vina del Mar

State/Province

ValparaÃ-so

ZIP/Postal Code

2520612

Country

Chile

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

8380455

Country

Chile

Facility Name

Research Site

City

Brno

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Research Site

City

Brno

ZIP/Postal Code

656 53

Country

Czechia

Facility Name

Research Site

City

Chomutov

ZIP/Postal Code

430 12

Country

Czechia

Facility Name

Research Site

City

Horovice

ZIP/Postal Code

268 31

Country

Czechia

Facility Name

Research Site

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Research Site

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

Research Site

City

Praha 10

ZIP/Postal Code

100 00

Country

Czechia

Facility Name

Research Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Research Site

City

Praha 4

ZIP/Postal Code

140 44

Country

Czechia

Facility Name

Research Site

City

Praha 5

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Research Site

City

Praha 8

ZIP/Postal Code

180 81

Country

Czechia

Facility Name

Research Site

City

Herning

ZIP/Postal Code

7400

Country

Denmark

Facility Name

Research Site

City

Vejle

ZIP/Postal Code

7100

Country

Denmark

Facility Name

Research Site

City

Viborg

ZIP/Postal Code

8800

Country

Denmark

Facility Name

Research Site

City

Ã…rhus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Research Site

City

Angers

ZIP/Postal Code

49933

Country

France

Facility Name

Research Site

City

Bordeaux Cedex

ZIP/Postal Code

33030

Country

France

Facility Name

Research Site

City

Dijon

ZIP/Postal Code

21079

Country

France

Facility Name

Research Site

City

Grenoble

ZIP/Postal Code

38000

Country

France

Facility Name

Research Site

City

HyÃ¨res

ZIP/Postal Code

83400

Country

France

Facility Name

Research Site

City

Le Mans

ZIP/Postal Code

72000

Country

France

Facility Name

Research Site

City

Lille

ZIP/Postal Code

59000

Country

France

Facility Name

Research Site

City

Monaco

ZIP/Postal Code

98012

Country

France

Facility Name

Research Site

City

Nantes Cedex 2

ZIP/Postal Code

44202

Country

France

Facility Name

Research Site

City

Paris

ZIP/Postal Code

75012

Country

France

Facility Name

Research Site

City

Pierre-Benite

ZIP/Postal Code

69495

Country

France

Facility Name

Research Site

City

Saint Priest en Jarez Cedex

ZIP/Postal Code

42270

Country

France

Facility Name

Research Site

City

Strasbourg cedex

ZIP/Postal Code

67091

Country

France

Facility Name

Research Site

City

Villejuif cedex

ZIP/Postal Code

94805

Country

France

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10713

Country

Germany

Facility Name

Research Site

City

Bonn

ZIP/Postal Code

53111

Country

Germany

Facility Name

Research Site

City

Bottrop

ZIP/Postal Code

46236

Country

Germany

Facility Name

Research Site

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Research Site

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Research Site

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Research Site

City

Koblenz

ZIP/Postal Code

56068

Country

Germany

Facility Name

Research Site

City

Mannheim

ZIP/Postal Code

68161

Country

Germany

Facility Name

Research Site

City

MÃ¼nchen

ZIP/Postal Code

80335

Country

Germany

Facility Name

Research Site

City

MÃ¼nchen

ZIP/Postal Code

80638

Country

Germany

Facility Name

Research Site

City

MÃ¼nchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

Research Site

City

Recklinghausen

ZIP/Postal Code

45657

Country

Germany

Facility Name

Research Site

City

Rostock

ZIP/Postal Code

18059

Country

Germany

Facility Name

Research Site

City

Trier

ZIP/Postal Code

54290

Country

Germany

Facility Name

Research Site

City

TÃ¼bingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Research Site

City

Athens

ZIP/Postal Code

11522

Country

Greece

Facility Name

Research Site

City

Athens

ZIP/Postal Code

11528

Country

Greece

Facility Name

Research Site

City

Heraklion

ZIP/Postal Code

71110

Country

Greece

Facility Name

Research Site

City

Patra

ZIP/Postal Code

26500

Country

Greece

Facility Name

Research Site

City

Thessaloniki

ZIP/Postal Code

54636

Country

Greece

Facility Name

Research Site

City

Thessaloniki

ZIP/Postal Code

56429

Country

Greece

Facility Name

Research Site

City

Hong Kong

Country

Hong Kong

Facility Name

Research Site

City

New Territories

Country

Hong Kong

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1032

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1082

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1125

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1145

Country

Hungary

Facility Name

Research Site

City

Debrecen

ZIP/Postal Code

4012

Country

Hungary

Facility Name

Research Site

City

Gyor

ZIP/Postal Code

9023

Country

Hungary

Facility Name

Research Site

City

Nyiregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Research Site

City

Pecs

ZIP/Postal Code

7624

Country

Hungary

Facility Name

Research Site

City

Szeged

ZIP/Postal Code

6725

Country

Hungary

Facility Name

Research Site

City

Szekesfehervar

ZIP/Postal Code

8000

Country

Hungary

Facility Name

Research Site

City

Szolnok

ZIP/Postal Code

5004

Country

Hungary

Facility Name

Research Site

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Research Site

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500 024

Country

India

Facility Name

Research Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560 054

Country

India

Facility Name

Research Site

City

Ahmednagar

State/Province

Maharashtra

ZIP/Postal Code

413 736

Country

India

Facility Name

Research Site

City

Aurangabad

State/Province

Maharashtra

ZIP/Postal Code

431 001

Country

India

Facility Name

Research Site

City

Miraj

State/Province

Maharashtra

ZIP/Postal Code

416 410

Country

India

Facility Name

Research Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400 012

Country

India

Facility Name

Research Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400 016

Country

India

Facility Name

Research Site

City

Nashik

State/Province

Maharashtra

ZIP/Postal Code

422 004

Country

India

Facility Name

Research Site

City

Nashik

State/Province

Maharashtra

ZIP/Postal Code

422 005

Country

India

Facility Name

Research Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411 001

Country

India

Facility Name

Research Site

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302 013

Country

India

Facility Name

Research Site

City

Chennai

State/Province

Tamil Nadu

ZIP/Postal Code

600 018

Country

India

Facility Name

Research Site

City

Madurai

State/Province

Tamil Nadu

ZIP/Postal Code

625 107

Country

India

Facility Name

Research Site

City

Cork

Country

Ireland

Facility Name

Research Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Research Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Research Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Research Site

City

Limerick

Country

Ireland

Facility Name

Research Site

City

Waterford

Country

Ireland

Facility Name

Research Site

City

Ashkelon

ZIP/Postal Code

78278

Country

Israel

Facility Name

Research Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Research Site

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

Research Site

City

Kfar Sava

ZIP/Postal Code

44281

Country

Israel

Facility Name

Research Site

City

Petah Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Research Site

City

Poria Eylit

ZIP/Postal Code

15208

Country

Israel

Facility Name

Research Site

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

Research Site

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Research Site

City

Tel Aviv

ZIP/Postal Code

69710

Country

Israel

Facility Name

Research Site

City

Ancona

ZIP/Postal Code

60131

Country

Italy

Facility Name

Research Site

City

Bari

ZIP/Postal Code

70124

Country

Italy

Facility Name

Research Site

City

Brescia

ZIP/Postal Code

25123

Country

Italy

Facility Name

Research Site

City

Meldola FC

ZIP/Postal Code

47014

Country

Italy

Facility Name

Research Site

City

Milano

ZIP/Postal Code

20142

Country

Italy

Facility Name

Research Site

City

Monza (MB)

ZIP/Postal Code

20900

Country

Italy

Facility Name

Research Site

City

Palermo

ZIP/Postal Code

90100

Country

Italy

Facility Name

Research Site

City

Parma

ZIP/Postal Code

43100

Country

Italy

Facility Name

Research Site

City

San Giovanni Rotondo FG

ZIP/Postal Code

71013

Country

Italy

Facility Name

Research Site

City

Treviglio (BG)

ZIP/Postal Code

24047

Country

Italy

Facility Name

Research Site

City

Varese

ZIP/Postal Code

21100

Country

Italy

Facility Name

Research Site

City

Nagoya-shi

State/Province

Aichi

ZIP/Postal Code

464-8681

Country

Japan

Facility Name

Research Site

City

Nagoya-shi

State/Province

Aichi

ZIP/Postal Code

467-8602

Country

Japan

Facility Name

Research Site

City

Matsuyama-shi

State/Province

Ehime

ZIP/Postal Code

791-0280

Country

Japan

Facility Name

Research Site

City

Fukuoka-shi

State/Province

Fukuoka

ZIP/Postal Code

811-1395

Country

Japan

Facility Name

Research Site

City

Kitakyushu-shi

State/Province

Fukuoka

ZIP/Postal Code

802-0077

Country

Japan

Facility Name

Research Site

City

Kurume-shi

State/Province

Fukuoka

ZIP/Postal Code

830-0013

Country

Japan

Facility Name

Research Site

City

Kure-shi

State/Province

Hiroshima

ZIP/Postal Code

737-0023

Country

Japan

Facility Name

Research Site

City

Akashi-shi

State/Province

Hyogo

ZIP/Postal Code

673-8558

Country

Japan

Facility Name

Research Site

City

Kagoshima-shi

State/Province

Kagoshima

ZIP/Postal Code

892-0833

Country

Japan

Facility Name

Research Site

City

Isehara-shi

State/Province

Kanagawa

ZIP/Postal Code

259-1193

Country

Japan

Facility Name

Research Site

City

Kumamoto-shi

State/Province

Kumamoto

ZIP/Postal Code

860-8556

Country

Japan

Facility Name

Research Site

City

Kyoto-shi

State/Province

Kyoto

ZIP/Postal Code

606-8507

Country

Japan

Facility Name

Research Site

City

Miyazaki-shi

State/Province

Miyazaki

ZIP/Postal Code

880-0052

Country

Japan

Facility Name

Research Site

City

Niigata-shi

State/Province

Niigata

ZIP/Postal Code

951-8566

Country

Japan

Facility Name

Research Site

City

Kurashiki-shi

State/Province

Okayama

ZIP/Postal Code

701-0192

Country

Japan

Facility Name

Research Site

City

Osaka-shi

State/Province

Osaka

ZIP/Postal Code

537-8511

Country

Japan

Facility Name

Research Site

City

Osaka-shi

State/Province

Osaka

ZIP/Postal Code

540-0006

Country

Japan

Facility Name

Research Site

City

Suita-shi

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

Research Site

City

Hidaka-Shi

State/Province

Saitama

ZIP/Postal Code

350-1298

Country

Japan

Facility Name

Research Site

City

Kitaadachi-gun

State/Province

Saitama

ZIP/Postal Code

362-0806

Country

Japan

Facility Name

Research Site

City

Suntou-gun

State/Province

Shizuoka

ZIP/Postal Code

411-8777

Country

Japan

Facility Name

Research Site

City

Shimotsuke-shi

State/Province

Tochigi

ZIP/Postal Code

329-0498

Country

Japan

Facility Name

Research Site

City

Utsunomiya-shi

State/Province

Tochigi

ZIP/Postal Code

320-0834

Country

Japan

Facility Name

Research Site

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

Research Site

City

Tokyo

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

Research Site

City

Tokyo

ZIP/Postal Code

142-8666

Country

Japan

Facility Name

Research Site

City

Tokyo

ZIP/Postal Code

160-0023

Country

Japan

Facility Name

Research Site

City

Tokyo

ZIP/Postal Code

173-0003

Country

Japan

Facility Name

Research Site

City

Goyang-si, Gyeonggi-do

ZIP/Postal Code

410-769

Country

Korea, Republic of

Facility Name

Research Site

City

Incheon

ZIP/Postal Code

405-835

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Research Site

City

Daugavpils

ZIP/Postal Code

5417

Country

Latvia

Facility Name

Research Site

City

Liepaja

ZIP/Postal Code

3401

Country

Latvia

Facility Name

Research Site

City

Riga

ZIP/Postal Code

1079

Country

Latvia

Facility Name

Research Site

City

Kota Bharu

State/Province

Kelantan

ZIP/Postal Code

16150

Country

Malaysia

Facility Name

Research Site

City

Subang Jaya

State/Province

Selangor (incl. Putrajaya)

ZIP/Postal Code

47500

Country

Malaysia

Facility Name

Research Site

City

Kuala Lumpur

State/Province

Wilayah Persekutuan

ZIP/Postal Code

50703

Country

Malaysia

Facility Name

Research Site

City

Kuala Lumpur

State/Province

Wilayah Persekutuan

ZIP/Postal Code

56000

Country

Malaysia

Facility Name

Research Site

City

Mexico City

State/Province

Distrito Federal

ZIP/Postal Code

06726

Country

Mexico

Facility Name

Research Site

City

Mexico City

State/Province

Distrito Federal

ZIP/Postal Code

07760

Country

Mexico

Facility Name

Research Site

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

01120

Country

Mexico

Facility Name

Research Site

City

Leon

State/Province

Guanajuato

ZIP/Postal Code

37670

Country

Mexico

Facility Name

Research Site

City

Pachuca de Soto

State/Province

Hidalgo

ZIP/Postal Code

42084

Country

Mexico

Facility Name

Research Site

City

Monterrey

State/Province

Nuevo LeÃ³n

ZIP/Postal Code

64000

Country

Mexico

Facility Name

Research Site

City

Queretaro

State/Province

QuerÃ©taro

ZIP/Postal Code

76178

Country

Mexico

Facility Name

Research Site

City

San Luis Potosi

State/Province

San Luis PotosÃ-

ZIP/Postal Code

78200

Country

Mexico

Facility Name

Research Site

City

Colima

ZIP/Postal Code

28030

Country

Mexico

Facility Name

Research Site

City

Distrito Federal

ZIP/Postal Code

11000

Country

Mexico

Facility Name

Research Site

City

Durango

ZIP/Postal Code

34000

Country

Mexico

Facility Name

Research Site

City

Toluca

ZIP/Postal Code

50180

Country

Mexico

Facility Name

Research Site

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

Research Site

City

Bergen op Zoom

ZIP/Postal Code

4624 VT

Country

Netherlands

Facility Name

Research Site

City

Breda

ZIP/Postal Code

4819 EV

Country

Netherlands

Facility Name

Research Site

City

Capelle aan den ijssel

ZIP/Postal Code

2906 ZC

Country

Netherlands

Facility Name

Research Site

City

Den Haag

ZIP/Postal Code

2545 CH

Country

Netherlands

Facility Name

Research Site

City

Dordrecht

ZIP/Postal Code

3318 AT

Country

Netherlands

Facility Name

Research Site

City

Hoofddorp

ZIP/Postal Code

2134 TM

Country

Netherlands

Facility Name

Research Site

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Research Site

City

Nieuwegein

ZIP/Postal Code

3435 CM

Country

Netherlands

Facility Name

Research Site

City

Rotterdam

ZIP/Postal Code

3045 PM

Country

Netherlands

Facility Name

Research Site

City

Rotterdam

ZIP/Postal Code

3075 EA

Country

Netherlands

Facility Name

Research Site

City

Schiedam

ZIP/Postal Code

3118 JH

Country

Netherlands

Facility Name

Research Site

City

Sittard-Geleen

ZIP/Postal Code

6162 BG

Country

Netherlands

Facility Name

Research Site

City

Tiel

ZIP/Postal Code

4002 WP

Country

Netherlands

Facility Name

Research Site

City

Tilburg

ZIP/Postal Code

5022 GC

Country

Netherlands

Facility Name

Research Site

City

Venlo

ZIP/Postal Code

5912 BL

Country

Netherlands

Facility Name

Research Site

City

Lima

ZIP/Postal Code

Lima 11

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

Lima 18

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

Lima 27

Country

Peru

Facility Name

Research Site

City

Cebu City

ZIP/Postal Code

6000

Country

Philippines

Facility Name

Research Site

City

Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

Research Site

City

Manila

ZIP/Postal Code

1008

Country

Philippines

Facility Name

Research Site

City

Metro Manila

ZIP/Postal Code

1100

Country

Philippines

Facility Name

Research Site

City

Quezon City

ZIP/Postal Code

1102

Country

Philippines

Facility Name

Research Site

City

Gdansk

ZIP/Postal Code

80-219

Country

Poland

Facility Name

Research Site

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Research Site

City

Krakow

ZIP/Postal Code

31-108

Country

Poland

Facility Name

Research Site

City

Olsztyn

ZIP/Postal Code

10-228

Country

Poland

Facility Name

Research Site

City

Poznan

ZIP/Postal Code

61-485

Country

Poland

Facility Name

Research Site

City

Rzeszow

ZIP/Postal Code

35-021

Country

Poland

Facility Name

Research Site

City

Szczecin

ZIP/Postal Code

71-730

Country

Poland

Facility Name

Research Site

City

Lisboa

ZIP/Postal Code

1099-023

Country

Portugal

Facility Name

Research Site

City

Lisboa

ZIP/Postal Code

1500-650

Country

Portugal

Facility Name

Research Site

City

Porto

ZIP/Postal Code

4200-072

Country

Portugal

Facility Name

Research Site

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

Research Site

City

Santa Maria da Feira

ZIP/Postal Code

4520-211

Country

Portugal

Facility Name

Research Site

City

Bucharest

ZIP/Postal Code

022328

Country

Romania

Facility Name

Research Site

City

Craiova

ZIP/Postal Code

200385

Country

Romania

Facility Name

Research Site

City

Sibiu

ZIP/Postal Code

550245

Country

Romania

Facility Name

Research Site

City

Suceava

ZIP/Postal Code

720237

Country

Romania

Facility Name

Research Site

City

Timisoara

ZIP/Postal Code

300239

Country

Romania

Facility Name

Research Site

City

Barnaul

ZIP/Postal Code

656049

Country

Russian Federation

Facility Name

Research Site

City

Chelyabinsk

ZIP/Postal Code

454076

Country

Russian Federation

Facility Name

Research Site

City

Ivanovo

ZIP/Postal Code

153013

Country

Russian Federation

Facility Name

Research Site

City

Kazan

ZIP/Postal Code

420029

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

195271

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Research Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Research Site

City

Nis

ZIP/Postal Code

18000

Country

Serbia

Facility Name

Research Site

City

Bardejov

ZIP/Postal Code

085 01

Country

Slovakia

Facility Name

Research Site

City

Kosice

ZIP/Postal Code

041 91

Country

Slovakia

Facility Name

Research Site

City

Michalovce

ZIP/Postal Code

071 01

Country

Slovakia

Facility Name

Research Site

City

Poprad

ZIP/Postal Code

058 01

Country

Slovakia

Facility Name

Research Site

City

Presov

ZIP/Postal Code

080 01

Country

Slovakia

Facility Name

Research Site

City

Spisska Nova Ves

ZIP/Postal Code

052 01

Country

Slovakia

Facility Name

Research Site

City

Trebisov

ZIP/Postal Code

075 01

Country

Slovakia

Facility Name

Research Site

City

Ljublijana

ZIP/Postal Code

1525

Country

Slovenia

Facility Name

Research Site

City

Maribor

ZIP/Postal Code

2000

Country

Slovenia

Facility Name

Research Site

City

Groenkloof

State/Province

Gauteng

ZIP/Postal Code

0181

Country

South Africa

Facility Name

Research Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Research Site

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Research Site

City

Pietermaritzburg

ZIP/Postal Code

3201

Country

South Africa

Facility Name

Research Site

City

Port Elizabeth

ZIP/Postal Code

6045

Country

South Africa

Facility Name

Research Site

City

Pretoria

ZIP/Postal Code

0002

Country

South Africa

Facility Name

Research Site

City

Pretoria

ZIP/Postal Code

0081

Country

South Africa

Facility Name

Research Site

City

CÃ¡diz

State/Province

AndalucÃ-a

ZIP/Postal Code

11009

Country

Spain

Facility Name

Research Site

City

CÃ³rdoba

State/Province

AndalucÃ-a

ZIP/Postal Code

14004

Country

Spain

Facility Name

Research Site

City

JaÃ©n

State/Province

AndalucÃ-a

ZIP/Postal Code

23007

Country

Spain

Facility Name

Research Site

City

MÃ¡laga

State/Province

AndalucÃ-a

ZIP/Postal Code

29010

Country

Spain

Facility Name

Research Site

City

Sevilla

State/Province

AndalucÃ-a

ZIP/Postal Code

41013

Country

Spain

Facility Name

Research Site

City

Zaragoza

State/Province

AragÃ³n

ZIP/Postal Code

50009

Country

Spain

Facility Name

Research Site

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Research Site

City

Badalona

State/Province

CataluÃ±a

ZIP/Postal Code

08916

Country

Spain

Facility Name

Research Site

City

Barcelona

State/Province

CataluÃ±a

ZIP/Postal Code

08003

Country

Spain

Facility Name

Research Site

City

Barcelona

State/Province

CataluÃ±a

ZIP/Postal Code

08035

Country

Spain

Facility Name

Research Site

City

Barcelona

State/Province

CataluÃ±a

ZIP/Postal Code

08036

Country

Spain

Facility Name

Research Site

City

Barcelona

State/Province

CataluÃ±a

ZIP/Postal Code

08041

Country

Spain

Facility Name

Research Site

City

Girona

State/Province

CataluÃ±a

ZIP/Postal Code

17007

Country

Spain

Facility Name

Research Site

City

Lleida

State/Province

CataluÃ±a

ZIP/Postal Code

25198

Country

Spain

Facility Name

Research Site

City

Sabadell

State/Province

CataluÃ±a

ZIP/Postal Code

08208

Country

Spain

Facility Name

Research Site

City

Elche

State/Province

Comunidad Valenciana

ZIP/Postal Code

03203

Country

Spain

Facility Name

Research Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46009

Country

Spain

Facility Name

Research Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46010

Country

Spain

Facility Name

Research Site

City

A CoruÃ±a

State/Province

Galicia

ZIP/Postal Code

15006

Country

Spain

Facility Name

Research Site

City

A CoruÃ±a

State/Province

Galicia

ZIP/Postal Code

15009

Country

Spain

Facility Name

Research Site

City

AlcorcÃ³n

State/Province

Madrid

ZIP/Postal Code

28922

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Research Site

City

Putzu City

State/Province

Chiayi

ZIP/Postal Code

61363

Country

Taiwan

Facility Name

Research Site

City

Keelung City

State/Province

Keelung

ZIP/Postal Code

20401

Country

Taiwan

Facility Name

Research Site

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06500

Country

Turkey

Facility Name

Research Site

City

Bornova-Izmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Research Site

City

Ä°zmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Research Site

City

Bebington

ZIP/Postal Code

CH63 4JY

Country

United Kingdom

Facility Name

Research Site

City

Birmingham

ZIP/Postal Code

B15 2TT

Country

United Kingdom

Facility Name

Research Site

City

Brighton

ZIP/Postal Code

BN2 5BE

Country

United Kingdom

Facility Name

Research Site

City

Bristol

ZIP/Postal Code

BS2 8ED

Country

United Kingdom

Facility Name

Research Site

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Research Site

City

Dorset

ZIP/Postal Code

BH7 7DW

Country

United Kingdom

Facility Name

Research Site

City

Guildford

ZIP/Postal Code

GU2 7XX

Country

United Kingdom

Facility Name

Research Site

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

Research Site

City

London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Research Site

City

London

ZIP/Postal Code

W2 1NY

Country

United Kingdom

Facility Name

Research Site

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Research Site

City

Manchester

ZIP/Postal Code

M23 9LT

Country

United Kingdom

Facility Name

Research Site

City

Newcastle

ZIP/Postal Code

NE4 6BE

Country

United Kingdom

Facility Name

Research Site

City

Peterborough

ZIP/Postal Code

PE3 9GZ

Country

United Kingdom

Facility Name

Research Site

City

Plymouth

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

Facility Name

Research Site

City

Poole

ZIP/Postal Code

BH15 2JB

Country

United Kingdom

Facility Name

Research Site

City

Portsmouth

ZIP/Postal Code

PO6 3LY

Country

United Kingdom

Facility Name

Research Site

City

Sheffield

ZIP/Postal Code

S10 2SJ

Country

United Kingdom

Facility Name

Research Site

City

Truro

ZIP/Postal Code

TR1 3LJ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

31806543

Citation

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.

Results Reference

background

PubMed Identifier

34185259

Citation

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.

Results Reference

background

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

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

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

Breast Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial