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A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Dato-DXd

Durvalumab

Capecitabine

Pembrolizumab

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, TNBC, Triple-negative, Adjuvant, Datopotamab Deruxtecan, Dato-DXd, DS1062a, Antibody Drug Conjugate, ADC, TROP2, Durvalumab

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participant must be ≥ 18 years at the time of screening. Histologically confirmed invasive TNBC, as defined by the ASCO/CAP guidelines. Residual invasive disease in the breast and/or axillary lymph node(s) at surgical resection following neoadjuvant therapy. Completed at least 6 cycles of neoadjuvant therapy containing an anthracycline and/or a taxane with or without carboplatin, with or without pembrolizumab. No evidence of locoregional or distant relapse. Surgical removal of all clinically evident disease in the breast and lymph nodes. ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to randomisation. All participants must provide an FFPE tumour sample from residual invasive disease at surgery for tissue-based analysis. No adjuvant systemic therapy. Radiotherapy (if indicated) delivered before the start of study intervention. If post-operative radiation therapy is given, an interval of no more than 6 weeks between the completion of radiation therapy and the date of randomisation (radiation therapy can be completed during screening period). If no post-operative radiation therapy is given, an interval of no more than 16 weeks between the date of breast surgery and the date of randomisation. Has LVEF ≥ 50% by either an ECHO or MUGA scan within 28 days before randomisation. Eligible for one of the therapy options listed as investigator's choice per investigator assessment. No known germline BRCA1 or BRCA2 mutation. Adequate bone marrow reserve and organ function within 7 days before randomisation. Exclusion Criteria: Stage IV (metastatic) TNBC. History of prior invasive breast cancer, or evidence of recurrent disease following preoperative therapy and surgery. Severe or uncontrolled medical conditions including systemic diseases, history of allogeneic organ transplant and active bleeding diseases, ongoing or active infection, serious chronic gastrointestinal conditions associated with diarrhea . History of another primary malignancy except for adequately resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin, in situ disease that has undergone potentially curative therapy, or other solid malignancy treated with curative intent with no known active disease within 5 years before randomisation and of low potential risk for recurrence. Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved to Grade ≤ 1 or baseline. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss). Active or prior documented autoimmune or inflammatory disorders. Clinically significant corneal disease. Active or uncontrolled hepatitis B or C virus infection. Known to have tested positive for HIV (positive HIV 1/2 antibodies). Active tuberculosis infection. Mean resting corrected QTcF > 470 ms regardless of gender, obtained from triplicate 12-lead ECGs performed at screening. Uncontrolled or significant cardiac disease. History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. Clinically severe pulmonary function compromise resulting from intercurrent pulmonary illnesses. Any known active liver disease. Grade ≥ 2 peripheral neuropathy of any aetiology. Prior exposure to a PD-1/PD-L1 inhibitor other than pembrolizumab. Current or prior use of immunosuppressive medication within 14 days prior to randomisation. Participants with a known severe hypersensitivity to Dato-DXd or any of the excipients of these products including but not limited to polysorbate 80 or other monoclonal antibodies. Participants with a known severe hypersensitivity to PD-1/PD-L1 inhibitors. Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 4 weeks prior to randomisation, randomisation into a prior Dato-DXd, T-DXd, or durvalumab study regardless of treatment assignment. Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Dato-DXd in combination with Durvalumab

Dato-DXd

Investigators Choice Therapy

Arm Description

Arm 1: Dato-DXd 6 mg/kg IV Q3W x 8 cycles + Durvalumab 1120 mg IV Q3W x 9 cycles

Arm 2: Dato-DXd 6 mg/kg IV Q3W x 8 cycles

Arm 3: Capecitabine (1000 or 1250 mg/m2 oral BID on Days 1 to 14, Q3W) for 8 cycles Pembrolizumab* (200 mg IV on Day 1, Q3W) for 9 cycles Capecitabine (1000 or 1250 mg/m2 oral BID on Days 1 to 14, Q3W) for 8 cycles + pembrolizumab* (200 mg IV on Day 1, Q3W) for 9 cycles * Only participants who have received prior pembrolizumab in the neoadjuvant setting should receive pembrolizumab as part of their adjuvant therapy on Arm 3.

Outcomes

Primary Outcome Measures

Invasive disease-free survival (iDFS) for Dato-DXd + durvalumab vs. ICT

iDFS is defined as time from randomisation until date of first occurrence of one of the following events: ipsilateral invasive breast tumour (local) recurrence, regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and skin of ipsilateral breast), or distant recurrence (metastatic breast cancer that has either been biopsy-confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; second primary non-breast invasive cancer (other than squamous or basal cell skin cancer); or death from any cause. iDFS will be determined based on disease recurrence per investigator assessment based on all available clinical assessments. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy. The measure of interest will be the HR (hazard ratio) of iDFS for Dato-DXd + durvalumab vs ICT.

Secondary Outcome Measures

Distant disease-free survival (DDFS) for Dato-DXd + durvalumab vs ICT

DDFS is defined as time from randomization to date of first distant recurrence, occurrence of second primary non-breast invasive cancer, or death from any cause. DDFS is determined based on disease recurrence per investigators assessment based on all available clinical assessments. The analysis will include all randomized participants, as randomized regardless of whether the participant withdraws from randomized therapy or received another anticancer therapy. The measure of interest will be the HR (hazard ratio) of DDFS for Dato-DXd + durvalumab vs ICT.

DDFS for Dato-DXd vs ICT

DDFS for Dato-DXd + durvalumab vs Dato-DXd

Overall Survival (OS) for Dato-DXd + durvalumab vs ICT

OS is defined as time from randomization until date of death due to any cause. The analysis will include all randomised participants, as randomised regardless of whether the participant withdraws from randomised therapy or received another anticancer therapy. The measure of interest will be the HR (hazard ratio) of OS for Dato-DXd + durvalumab vs ICT.

OS for Dato-DXd vs ICT

OS is defined as time from randomization until date of death due to any cause. The measure of interest will be the HR of OS for Dato-DXd vs ICT.

iDFS for Dato-DXd vs ICT

iDFS for Dato-DXd + durvalumab vs Dato-DXd

Time to Deterioration (TTD) in physical functioning in participants treated with Dato-DXd with or without durvalumab compared with ICT

TTD in physical function as measured by the PROMIS Physical Function Short Form 8c.TTD is defined as time from the date of randomisation to the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analysis will include all dosed participants. The measure of interest is the HR (hazard ratio) of TTD in physical function for Dato-DXd with or without durvalumab compared with ICT.

Time to Deterioration (TTD) in GHS/QoL in participants treated with Dato-DXd with or without durvalumab compared with ICT

TTD in GHS/QoL as measured by the GHS/QoL scale from the EORTC IL172. TTD is defined as time from the date of randomisation to the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analysis will include all randomised participants. The measure of interest is the HR (hazard ratio) of TTD in GHS/QoL for Dato-DXd with or without durvalumab compared with ICT.

Fatigue in participants treated with Dato-DXd with or without durvalumab vs ICT

Proportion of participants experiencing different levels of fatigue at 3 months (13weeks), 6 months (26 weeks), and 12 months (52 weeks) as measured by PROMIS Fatigue Short Form 7a. The analysis will include all dosed participants. The measure of interest will be the proportion of participants reporting different levels of fatigue.

Pharmacokinetics of Dato-DXd

Concentration of Dato- DXd, total anti-TROP2 antibody, and MAAA-1181 in plasma.

Immunogenicity of Dato-DXd

Presence of ADAs for Dato-DXd (confirmatory results: positive or negative; titres).

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

Safety and tolerability will be evaluated in terms of AEs (graded by CTCAE version 5.0).

Full Information

NCT ID

NCT05629585

First Posted

November 4, 2022

Last Updated

September 27, 2023

Sponsor

AstraZeneca

Collaborators

Daiichi Sankyo, Inc., SWOG Clinical Trials Partnerships

1. Study Identification

Unique Protocol Identification Number

NCT05629585

Brief Title

A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)

Official Title

A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 28, 2022 (Actual)

Primary Completion Date

September 20, 2027 (Anticipated)

Study Completion Date

March 27, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Daiichi Sankyo, Inc., SWOG Clinical Trials Partnerships

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.

Detailed Description

The study will investigate the efficacy and safety of Dato-DXd with or without durvalumab when compared with ICT (capecitabine and/or pembrolizumab) in participants with stage I to III TNBC who have residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy. The primary objective of the study is to demonstrate superiority of Dato-DXd in combination with durvalumab relative to ICT by assessment of iDFS in participants with stage I to III TNBC with residual invasive disease at surgical resection following neoadjuvant therapy.

6. Conditions and Keywords

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

Breast Cancer

Keywords

Breast Cancer, TNBC, Triple-negative, Adjuvant, Datopotamab Deruxtecan, Dato-DXd, DS1062a, Antibody Drug Conjugate, ADC, TROP2, Durvalumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Parallel

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1075 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dato-DXd in combination with Durvalumab

Arm Type

Experimental

Arm Description

Arm 1: Dato-DXd 6 mg/kg IV Q3W x 8 cycles + Durvalumab 1120 mg IV Q3W x 9 cycles

Arm Title

Dato-DXd

Arm Type

Experimental

Arm Description

Arm 2: Dato-DXd 6 mg/kg IV Q3W x 8 cycles

Arm Title

Investigators Choice Therapy

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Dato-DXd

Other Intervention Name(s)

Datopotamab deruxtecan (Dato-DXd, DS-1062a)

Intervention Description

Experimental drug. Provided in 100mg vials. IV infusion

Intervention Type

Drug

Intervention Name(s)

Durvalumab

Other Intervention Name(s)

MEDI4736

Intervention Description

Experimental drug. Provided in 50mg vials. IV infusion

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

XELODA®, Capecitabine Cell Pharm, Capecitabine EG, Capecitabine Accord

Intervention Description

Active Comparator. Tablet. Oral route of administration

Intervention Type

Drug

Intervention Name(s)

Pembrolizumab

Other Intervention Name(s)

KEYTRUDA®

Intervention Description

Active Comparator. Provided in 100mg vials. IV infusion

Primary Outcome Measure Information:

Title

Invasive disease-free survival (iDFS) for Dato-DXd + durvalumab vs. ICT

Description

Time Frame

From randomization until recurrence as assessed by investigator or death due to any cause up to 57 months from first subject in

Secondary Outcome Measure Information:

Title

Distant disease-free survival (DDFS) for Dato-DXd + durvalumab vs ICT

Description

Time Frame

Randomization to date of the event, up to 57 months from first subject in

Title

DDFS for Dato-DXd vs ICT

Description

Time Frame

Randomization to date of the event, up to 57 months from first subject in

Title

DDFS for Dato-DXd + durvalumab vs Dato-DXd

Description

Time Frame

Randomization to date of the event, up 57 months from first subject in

Title

Overall Survival (OS) for Dato-DXd + durvalumab vs ICT

Description

Time Frame

Randomization to date of death, due to any cause, up to 87 months from first subject in

Title

OS for Dato-DXd vs ICT

Description

OS is defined as time from randomization until date of death due to any cause. The measure of interest will be the HR of OS for Dato-DXd vs ICT.

Time Frame

Randomization to date of death, due to any cause, up to 87 months from first subject in

Title

iDFS for Dato-DXd vs ICT

Description

Time Frame

Randomization to event, up to 57 months from first subject in

Title

iDFS for Dato-DXd + durvalumab vs Dato-DXd

Description

Time Frame

Randomization to event, up to 57 months from first subject in

Title

Time to Deterioration (TTD) in physical functioning in participants treated with Dato-DXd with or without durvalumab compared with ICT

Description

Time Frame

Randomization to date of the event, up to 36 months after randomization

Title

Time to Deterioration (TTD) in GHS/QoL in participants treated with Dato-DXd with or without durvalumab compared with ICT

Description

Time Frame

Randomization to date of the event, up to 36 months after randomization

Title

Fatigue in participants treated with Dato-DXd with or without durvalumab vs ICT

Description

Time Frame

Randomization to 24 months after randomization

Title

Pharmacokinetics of Dato-DXd

Description

Concentration of Dato- DXd, total anti-TROP2 antibody, and MAAA-1181 in plasma.

Time Frame

Day 1 of cycles 1,2,4,6,8 (Each cycle is 21 days)

Title

Immunogenicity of Dato-DXd

Description

Presence of ADAs for Dato-DXd (confirmatory results: positive or negative; titres).

Time Frame

Day 1 of cycles 1,2,4,6,8 (Each cycle is 21 days) and within 35 days of completion of or discontinuation of study intervention (at an average of 6 months following randomization)

Title

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

Description

Safety and tolerability will be evaluated in terms of AEs (graded by CTCAE version 5.0).

Time Frame

Randomization to final safety follow-up visit, either 90 days after last dose of study intervention for those who complete planned study intervention or 90 days after date of discontinuation for those who discontinue study intervention prematurely

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

130 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

AstraZeneca Clinical Study Information Center

Phone

1-877-240-9479

information.center@astrazeneca.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aditya Bardia, MD, MPH

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Research Site

City

Anchorage

State/Province

Alaska

ZIP/Postal Code

99508

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85284

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85711

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85719

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Hot Springs National Park

State/Province

Arkansas

ZIP/Postal Code

71913

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Springdale

State/Province

Arkansas

ZIP/Postal Code

72762

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92627

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Harbor City

State/Province

California

ZIP/Postal Code

90710

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Irvine

State/Province

California

ZIP/Postal Code

92618

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Laguna Hills

State/Province

California

ZIP/Postal Code

92653

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Loma Linda

State/Province

California

ZIP/Postal Code

92354

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90805

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Newport Beach

State/Province

California

ZIP/Postal Code

92660

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Oakland

State/Province

California

ZIP/Postal Code

94612

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Sunnyvale

State/Province

California

ZIP/Postal Code

94086

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Torrance

State/Province

California

ZIP/Postal Code

90505

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

West Hollywood

State/Province

California

ZIP/Postal Code

90048

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Whittier

State/Province

California

ZIP/Postal Code

90602

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80220

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Newark

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Altamonte Springs

State/Province

Florida

ZIP/Postal Code

32701

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33901

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33140

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Palm Bay

State/Province

Florida

ZIP/Postal Code

32909

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32308

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Athens

State/Province

Georgia

ZIP/Postal Code

30607

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30318

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96826

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Arlington Heights

State/Province

Illinois

ZIP/Postal Code

60005

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Decatur

State/Province

Illinois

ZIP/Postal Code

62526

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Park Ridge

State/Province

Illinois

ZIP/Postal Code

60068

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

New Albany

State/Province

Indiana

ZIP/Postal Code

47150

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50314

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Westwood

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Elizabethtown

State/Province

Kentucky

ZIP/Postal Code

42701

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40241

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70121

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Annapolis

State/Province

Maryland

ZIP/Postal Code

21401

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21202

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Columbia

State/Province

Maryland

ZIP/Postal Code

21044

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Billings

State/Province

Montana

ZIP/Postal Code

59102

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198-5885

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Reno

State/Province

Nevada

ZIP/Postal Code

89502

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Camden

State/Province

New Jersey

ZIP/Postal Code

08103

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

East Brunswick

State/Province

New Jersey

ZIP/Postal Code

08816

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Ridgewood

State/Province

New Jersey

ZIP/Postal Code

07450

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10075

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Westbury

State/Province

New York

ZIP/Postal Code

11590

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Canton

State/Province

Ohio

ZIP/Postal Code

44710

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43219

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97223

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97227

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18103

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Harrisburg

State/Province

Pennsylvania

ZIP/Postal Code

17101

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

York

State/Province

Pennsylvania

ZIP/Postal Code

17403

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

West Columbia

State/Province

South Carolina

ZIP/Postal Code

29169

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37916

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38120

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Bedford

State/Province

Texas

ZIP/Postal Code

76022

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75251

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Denton

State/Province

Texas

ZIP/Postal Code

76201

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

El Paso

State/Province

Texas

ZIP/Postal Code

79915

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76177

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77024

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79430

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

McAllen

State/Province

Texas

ZIP/Postal Code

78503

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22031

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Gainesville

State/Province

Virginia

ZIP/Postal Code

20155

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Gainesville

State/Province

Virginia

ZIP/Postal Code

20155

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Midlothian

State/Province

Virginia

ZIP/Postal Code

23114

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24014

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Edmonds

State/Province

Washington

ZIP/Postal Code

98026

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Kennewick

State/Province

Washington

ZIP/Postal Code

99336

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Puyallup

State/Province

Washington

ZIP/Postal Code

98373

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98133

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Spokane Valley

State/Province

Washington

ZIP/Postal Code

99216

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Anderlecht

ZIP/Postal Code

1070

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Research Site

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Research Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Research Site

City

Charleroi

ZIP/Postal Code

6000

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Research Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Research Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Research Site

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Research Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Research Site

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Research Site

City

Sint-Niklaas

ZIP/Postal Code

9100

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Research Site

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Research Site

City

Brasilia

ZIP/Postal Code

71681-603

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Research Site

City

Porto Alegre

ZIP/Postal Code

90035-000

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Research Site

City

Recife

ZIP/Postal Code

52010-075

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Research Site

City

Salvador

ZIP/Postal Code

41253-190

Country

Brazil

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Sao Paulo

ZIP/Postal Code

01321-001

Country

Brazil

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Sao Paulo

ZIP/Postal Code

01323-903

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Research Site

City

Sao Paulo

ZIP/Postal Code

01508-010

Country

Brazil

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Sao Paulo

ZIP/Postal Code

04532-030

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Research Site

City

São Paulo

ZIP/Postal Code

03102-002

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Research Site

City

Vitória

ZIP/Postal Code

29055-450

Country

Brazil

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

North Vancouver

State/Province

British Columbia

ZIP/Postal Code

V7L 2L7

Country

Canada

Individual Site Status

Recruiting

Facility Name

Research Site

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 6M2

Country

Canada

Individual Site Status

Recruiting

Facility Name

Research Site

City

Oakville

State/Province

Ontario

ZIP/Postal Code

L9T 6G2

Country

Canada

Individual Site Status

Recruiting

Facility Name

Research Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Individual Site Status

Recruiting

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X5

Country

Canada

Individual Site Status

Recruiting

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Individual Site Status

Recruiting

Facility Name

Research Site

City

Laval

State/Province

Quebec

ZIP/Postal Code

H7M 3L9

Country

Canada

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 0C1

Country

Canada

Individual Site Status

Recruiting

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Individual Site Status

Recruiting

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Individual Site Status

Recruiting

Facility Name

Research Site

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1S 4L8

Country

Canada

Individual Site Status

Recruiting

Facility Name

Research Site

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 4H4

Country

Canada

Individual Site Status

Recruiting

Facility Name

Research Site

City

Beijing

ZIP/Postal Code

100044

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Bengbu

ZIP/Postal Code

233060

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Changchun

ZIP/Postal Code

130021

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Changsha

ZIP/Postal Code

410008

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Chengdu

ZIP/Postal Code

610000

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Chengdu

ZIP/Postal Code

610072

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Chongqing

ZIP/Postal Code

400030

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Fuzhou

ZIP/Postal Code

350011

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Guangzhou

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Guangzhou

ZIP/Postal Code

510100

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Guangzhou

ZIP/Postal Code

510120

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Guangzhou

ZIP/Postal Code

510700

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Haikou

ZIP/Postal Code

570311

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Hangzhou

ZIP/Postal Code

310009

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Hangzhou

ZIP/Postal Code

310020

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Harbin

ZIP/Postal Code

150081

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Hefei

ZIP/Postal Code

230001

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Jinan

ZIP/Postal Code

250030

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Nanchang

ZIP/Postal Code

330009

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Nanjing

ZIP/Postal Code

210008

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Nanjing

ZIP/Postal Code

210009

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Nanning

ZIP/Postal Code

530021

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Qingdao

ZIP/Postal Code

110016

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Shanghai

ZIP/Postal Code

200025

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Shenzhen

ZIP/Postal Code

518020

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Shijiazhuang

ZIP/Postal Code

050020

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Taiyuan

ZIP/Postal Code

030000

Country

China

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Tianjin

ZIP/Postal Code

300060

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Wuhan

ZIP/Postal Code

430022

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Wuhan

ZIP/Postal Code

430060

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Xi'an

ZIP/Postal Code

710038

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Xiamen

ZIP/Postal Code

361003

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Zhengzhou

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Individual Site Status

Recruiting

Facility Name

Research Site

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Individual Site Status

Recruiting

Facility Name

Research Site

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Individual Site Status

Recruiting

Facility Name

Research Site

City

Herning

ZIP/Postal Code

7400

Country

Denmark

Individual Site Status

Recruiting

Facility Name

Research Site

City

Næstved

ZIP/Postal Code

4700

Country

Denmark

Individual Site Status

Recruiting

Facility Name

Research Site

City

Odense C

ZIP/Postal Code

5000

Country

Denmark

Individual Site Status

Recruiting

Facility Name

Research Site

City

Sønderborg

ZIP/Postal Code

6400

Country

Denmark

Individual Site Status

Recruiting

Facility Name

Research Site

City

Vejle

ZIP/Postal Code

7100

Country

Denmark

Individual Site Status

Recruiting

Facility Name

Research Site

City

Angers Cedex 02

ZIP/Postal Code

49055

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Dijon

ZIP/Postal Code

21000

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Epagny Metz-Tessy

ZIP/Postal Code

74370

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Lyon

ZIP/Postal Code

69008

Country

France

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Montpellier

ZIP/Postal Code

34070

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Nimes

ZIP/Postal Code

30029

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Paris Cedex 05

ZIP/Postal Code

75248

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Poitiers

ZIP/Postal Code

86021

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Rennes

ZIP/Postal Code

35000

Country

France

Individual Site Status

Suspended

Facility Name

Research Site

City

Saint Herblain Cedex

ZIP/Postal Code

44805

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54000

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Villejuif Cedex

ZIP/Postal Code

94805

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Augsburg

ZIP/Postal Code

86156

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10967

Country

Germany

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Frankfurt am Main

ZIP/Postal Code

65929

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

20357

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Hannover

ZIP/Postal Code

30177

Country

Germany

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Heilbronn

ZIP/Postal Code

74078

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Langen

ZIP/Postal Code

63225

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Leipzig

ZIP/Postal Code

4103

Country

Germany

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Ludwigsburg

ZIP/Postal Code

71640

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Mönchengladbach

ZIP/Postal Code

41061

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

München

ZIP/Postal Code

80337

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Paderborn

ZIP/Postal Code

33098

Country

Germany

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Stuttgart

ZIP/Postal Code

70199

Country

Germany

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Troisdorf

ZIP/Postal Code

53840

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Witten

ZIP/Postal Code

58452

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Wuppertal

ZIP/Postal Code

42283

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Athens

ZIP/Postal Code

115 22

Country

Greece

Individual Site Status

Recruiting

Facility Name

Research Site

City

Athens

ZIP/Postal Code

11528

Country

Greece

Individual Site Status

Recruiting

Facility Name

Research Site

City

Athens

ZIP/Postal Code

12462

Country

Greece

Individual Site Status

Recruiting

Facility Name

Research Site

City

Athens

ZIP/Postal Code

15123

Country

Greece

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Heraklion

ZIP/Postal Code

711 11

Country

Greece

Individual Site Status

Recruiting

Facility Name

Research Site

City

Patras

ZIP/Postal Code

26504

Country

Greece

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Thessaloniki

ZIP/Postal Code

54645

Country

Greece

Individual Site Status

Recruiting

Facility Name

Research Site

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Brescia

ZIP/Postal Code

25123

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Genova

ZIP/Postal Code

16132

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Livorno

ZIP/Postal Code

57124

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Meldola

ZIP/Postal Code

47014

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Messina

ZIP/Postal Code

98158

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Milano

ZIP/Postal Code

20132

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Milan

ZIP/Postal Code

20141

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Padova

ZIP/Postal Code

35128

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Roma

ZIP/Postal Code

00168

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Rozzano

ZIP/Postal Code

20089

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Akashi-shi

ZIP/Postal Code

673-8558

Country

Japan

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Chiba-shi

ZIP/Postal Code

260-8717

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Chuo-ku

ZIP/Postal Code

104-0045

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Fukuoka

ZIP/Postal Code

811-1395

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Fukushima-shi

ZIP/Postal Code

960-1295

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Hiroshima-shi

ZIP/Postal Code

730-8518

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Isehara-shi

ZIP/Postal Code

259-1193

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kashiwa

ZIP/Postal Code

277-8577

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kitaadachi-gun

ZIP/Postal Code

362-0806

Country

Japan

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Koto-ku

ZIP/Postal Code

135-8550

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kyoto-shi

ZIP/Postal Code

606-8507

Country

Japan

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Matsuyama-shi

ZIP/Postal Code

791-0280

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Nagoya-shi

ZIP/Postal Code

464-8681

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Nagoya-shi

ZIP/Postal Code

466-8560

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Niigata-shi

ZIP/Postal Code

951-8566

Country

Japan

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Nishinomiya-shi

ZIP/Postal Code

663-8501

Country

Japan

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Okayama-shi

ZIP/Postal Code

700-8558

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Osaka-shi

ZIP/Postal Code

541-8567

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Ota-shi

ZIP/Postal Code

373-8550

Country

Japan

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Sapporo-shi

ZIP/Postal Code

003-0804

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Sendai-shi

ZIP/Postal Code

980-8574

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Shinagawa-ku

ZIP/Postal Code

142-8666

Country

Japan

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Shinjuku-ku

ZIP/Postal Code

162-8655

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Tsukuba

ZIP/Postal Code

305-8577

Country

Japan

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

241-8515

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Busan

ZIP/Postal Code

49241

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Research Site

City

Daegu

ZIP/Postal Code

41404

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Research Site

City

Goyang-si

ZIP/Postal Code

10408

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Research Site

City

Seongnam-Si

ZIP/Postal Code

463-712

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

02841

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06273

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

13620

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Research Site

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

08028

Country

Spain

Individual Site Status

Recruiting

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

8035

Country

Spain

Individual Site Status

Recruiting

Facility Name

Research Site

City

Bilbao (Vizcaya)

ZIP/Postal Code

48013

Country

Spain

Individual Site Status

Recruiting

Facility Name

Research Site

City

Elche(Alicante)

ZIP/Postal Code

03202

Country

Spain

Individual Site Status

Recruiting

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Individual Site Status

Recruiting

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Individual Site Status

Recruiting

Facility Name

Research Site

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Individual Site Status

Recruiting

Facility Name

Research Site

City

Palma de Mallorca

ZIP/Postal Code

07010

Country

Spain

Individual Site Status

Recruiting

Facility Name

Research Site

City

Toledo

ZIP/Postal Code

45007

Country

Spain

Individual Site Status

Recruiting

Facility Name

Research Site

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Individual Site Status

Recruiting

Facility Name

Research Site

City

Göteborg

ZIP/Postal Code

413 45

Country

Sweden

Individual Site Status

Recruiting

Facility Name

Research Site

City

Jönköping

ZIP/Postal Code

55185

Country

Sweden

Individual Site Status

Recruiting

Facility Name

Research Site

City

Malmö

ZIP/Postal Code

20502

Country

Sweden

Individual Site Status

Recruiting

Facility Name

Research Site

City

Stockholm

ZIP/Postal Code

11281

Country

Sweden

Individual Site Status

Recruiting

Facility Name

Research Site

City

Stockholm

ZIP/Postal Code

118 83

Country

Sweden

Individual Site Status

Recruiting

Facility Name

Research Site

City

Stockholm

ZIP/Postal Code

17176

Country

Sweden

Individual Site Status

Recruiting

Facility Name

Research Site

City

Sundsvall

ZIP/Postal Code

851 86

Country

Sweden

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

Individual Site Status

Recruiting

Facility Name

Research Site

City

Hsinchu

ZIP/Postal Code

300

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Tainan City

ZIP/Postal Code

70403

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

10449

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Yung Kang City

ZIP/Postal Code

71044

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

Cardiff

ZIP/Postal Code

CF14 2TL

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

Derry

ZIP/Postal Code

BT47 6SB

Country

United Kingdom

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Derry

ZIP/Postal Code

BT47 6SB

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

Edinburgh

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

Greater London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

Newcastle upon Tyne

ZIP/Postal Code

NE7 7AF

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

Portsmouth

ZIP/Postal Code

PO6 3LY

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

Taunton

ZIP/Postal Code

TA1 5DA

Country

United Kingdom

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing URL

https://astrazenecagroup-dt.pharmacm.com/DT/Home

Learn more about this trial

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A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)

Breast Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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