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A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease (SERENA-4)

Primary Purpose

ER-Positive HER2-Negative Breast Cancer

Status

Recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

AZD9833

Anastrozole

Anastrozole placebo

AZD9833 placebo

Palbociclib

Luteinizing hormone-releasing hormone (LHRH) agonist

About this trial

This is an interventional treatment trial for ER-Positive HER2-Negative Breast Cancer focused on measuring Metastatic, Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases, Hormones, Hormone Substitutes, and Hormone, Physiological Effects of Drugs, Randomised, Multicentre, Double-Blind, Phase III, AZD9833, Next Generation Oral SERD, Anastrozole, Palbociclib, Antagonists, Antineoplastic Agents, Estrogen Receptor Antagonists, Hormone Antagonists, camizestrant

Eligibility Criteria

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

INCLUSION CRITERIA

Full list of inclusion criteria

Pre-/peri-menopausal women or men can be enrolled if amenable to be treated with concomitant, approved LHRH agonists for the duration of the study treatment.
De novo Stage 4 disease, or recurrence from early stage disease after at least 24 months of standard adjuvant endocrine therapy. Note that at least 12 months must have elapsed since the patient's last dose of adjuvant AI therapy without disease progression on treatment. Note that a 2-week washout period is required after the last dose of tamoxifen prior to randomisation.
Histologically or cytologically documented diagnosis of ER+, HER2-negative breast cancer based on local laboratory results.
Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease.
Measurable disease as defined per RECIST v.1.1 OR at least one lytic or mixed (lytic + sclerotic) bone lesion with a soft tissue component that can be assessed by CT or MRI.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Adequate organ and marrow function.
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

INFORMATION FOR TRIAL PARTICIPANTS

Participants can join the trial if they:

Have breast cancer that cannot be treated with surgery or radiation
Have breast cancer that has already spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of a standard endocrine treatment
Have ER proteins but not overexpression of HER2 protein in their tumors
Have never received any type of cancer therapy that affects the whole body for advanced breast cancer
Are able to do their daily activities

EXCLUSION CRITERIA

Full list of exclusion criteria

Previous neoadjuvant or adjuvant treatment with an AI treatment +/- CDK4/6 inhibitor with disease recurrence while on or within 12 months of completing treatment.
Prior exposure to AZD9833, other investigational SERDs/endocrine agents or fulvestrant.
Participation in another clinical study with a study treatment or investigational medicinal device administered in the last 4 weeks prior to randomization or concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
Advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term and/or impending visceral crisis
Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.
Any clinically important and symptomatic heart disease .
Currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, renal transplant and active bleeding diseases) which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
Any concurrent anti-cancer treatment.
Active infection including tuberculosis, HBV and HCV.

INFORMATION FOR TRIAL PARTICIPANTS

Participants cannot join the trial if they:

Have uncontrolled cancer that has spread to the brain or the spinal cord
Have received certain treatments for cancer in the past but the cancer came back within 1 year
Had certain types of tumors in the past, which the study doctors think could come back
Are currently taking any treatment for cancer or are taking medications or supplements that affect certain proteins in the body
Have any major health problem, infection, or surgery that could make it difficult or dangerous to participate in this trial, such as tuberculosis, HIV, heart problems, or a kidney transplant

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AZD9833 + palbociclib

Anastrozole + palbociclib

Arm Description

The patients will receive AZD9833 (75 mg, PO, once daily) + palbociclib (PO, once daily, 125 mg for 21 consecutive days followed by 7 days off treatment) + anastrozole placebo (1 mg, PO, once daily)

The patients will recieve Anastrozole (1 mg, PO, once daily) + palbociclib (PO, once daily, 125 mg for 21 consecutive days followed by 7 days off treatment) + AZD9833 placebo (PO, once daily)

Outcomes

Primary Outcome Measures

Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1

PFS is defined as the time from randomization to objective disease progression (as assessed by RECIST) or death.

Secondary Outcome Measures

Overall survival (OS)

The OS is defined as the time from randomization to death due to any cause.

Second progression-free survival (PFS2)

Time to second progression or death (PFS2) will be defined as the time from randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death.

Objective response rate (ORR) assessed by the Investigator as defined by RECIST version 1.1

ORR is defined as the proportion of patients who have a CR or partial response, as determined by the investigator at local site per RECIST 1.1.

Duration of response (DoR) assessed by the Investigator as defined by RECIST version 1.1

The DoR will be defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression.

Time to chemotherapy (TTC)

Time to chemotherapy is defined as the time from randomization until the earlier of the start date of chemotherapy or death due to any cause.

Time to first subsequent anti-cancer therapy (TFST)

TFST is defined as time from randomization until the earlier of start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment, or death due to any cause.

Clinical benefit rate at 24 weeks (CBR24)

CBR at 24 weeks is defined as the percentage of participants who have a complete response (CR) or partial response or who have stable disease (SD) per RECIST 1.1 as assessed by the investigator at local site for at least 23 weeks after randomization (to allow for an early assessment within the assessment window).

Time to second subsequent therapy (TSST)

TSST is defined as time from randomization until the earlier of start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment, or death due to any cause.

Plasma concentration of AZD9833 at specified timepoints

To assess the steady state PK of AZD9833 in combination with palbociclib in all participants who receive at least one dose of AZD9833 per the protocol, for whom there are at least one reportable PK concentration.

Change from baseline in EORTC QLQ-C30 scale scores

Change from baseline in EORTC QLQ-C30 scale scores for each patient at each post-baseline visit. The comparison will include all randomised patients, as randomised, with baseline and at least one post-baseline visit score for the scale score.

Change from baseline in EORTC QLQ-BR45 scale scores

Change from baseline in EORTC QLQ-BR45 scale scores for each patient at each post-baseline visit. The comparison will include all randomised patients, as randomised, with baseline and at least one post-baseline visit score for the scale score.

Full Information

NCT ID

NCT04711252

First Posted

December 23, 2020

Last Updated

October 12, 2023

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT04711252

Brief Title

A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

Acronym

SERENA-4

Official Title

SERENA-4: A Randomised, Multicentre, Double-Blind, Phase III Study of AZD9833 (an Oral SERD) Plus Palbociclib Versus Anastrozole Plus Palbociclib for the Treatment of Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 28, 2021 (Actual)

Primary Completion Date

August 24, 2026 (Anticipated)

Study Completion Date

February 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

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

The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone receptor-positive (ER-positive), human epidermal growth factor 2-negative (HER2-negative) advanced/metastatic breast cancer. INFORMATION FOR TRIAL PARTICIPANTS In this trial, the researchers will look at how well camizestrant with palbociclib works, compared with anastrozole with palbociclib, in participants with breast cancer that has either spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of standard endocrine treatment. Participants in this trial will have breast cancer that has ER proteins but does not have overexpression of HER2 protein.

Detailed Description

A Randomised, Multicentre, Double-Blind, Phase III study will evaluate the safety and efficacy of AZD9833 (next generation oral SERD) in combination with palbociclib versus anastrozole in combination with palbociclib for the treatment of patients with ER-positive breast cancer. The goal of the study is to demonstrate superiority of AZD9833 over anastrozole in the context of combination with palbociclib in first line setting. INFORMATION FOR TRIAL PARTICIPANTS Researchers are looking for a better way to treat breast cancer. In people with cancer, some cells have grown out of control to form tumours. The trial drugs palbociclib, camizestrant, and anastrozole are designed to work by blocking the cancer's ability to grow. Camizestrant is also called AZD9833. Palbociclib and anastrozole are already available as treatments for people with certain type of breast cancer. In this trial, the researchers want to find out how well taking camizestrant with palbociclib, or anastrozole with palbociclib, works in participants with breast cancer that has ER proteins but does not have overexpression of HER2 protein. The researchers will look at which trial treatments help the participants live longer with cancer before it gets worse. The trial will split participants into 2 groups: Participants in Group 1 will take camizestrant, palbociclib, and a placebo matched with anastrazole. Participants in Group 2 will take anastrozole, palbociclib, , and a placebo matched with camizestrant. A placebo looks like a treatment but does not have any medicine in it. A computer program will be used to randomly choose the treatments each participant gets. This helps make sure the groups are chosen fairly. Researchers do this so that comparing the results of each treatment will be as accurate as possible. The participants will take their trial treatments in periods called "cycles". Each cycle will last 28 days. During each cycle, the participants will take: camizestrant or anastrozole once daily by mouth palbociclib once daily by mouth for 21 days. Then, they will not take any palbociclib for 7 days Some participants will also get either goserelin or leuprorelin once every month. Participants could get goserelin or leuprorelin if: They are medically determined yet to reach menopause status They are male They will get this treatment as an injection under the skin or into a muscle. Goserelin and leuprorelin work by decreasing the amount of sex hormones made by the body which will lead to reduction of ER production. This can help stop breast cancer from growing. Participants will take trial treatment until the cancer gets worse or they leave the trial. Participants will visit their trial site several times throughout the trial. At these visits, the trial doctors will check the health of the participants. They will also take blood samples and do scans of the participants' tumors.

6. Conditions and Keywords

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

ER-Positive HER2-Negative Breast Cancer

Keywords

Metastatic, Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases, Hormones, Hormone Substitutes, and Hormone, Physiological Effects of Drugs, Randomised, Multicentre, Double-Blind, Phase III, AZD9833, Next Generation Oral SERD, Anastrozole, Palbociclib, Antagonists, Antineoplastic Agents, Estrogen Receptor Antagonists, Hormone Antagonists, camizestrant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1342 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AZD9833 + palbociclib

Arm Type

Experimental

Arm Description

The patients will receive AZD9833 (75 mg, PO, once daily) + palbociclib (PO, once daily, 125 mg for 21 consecutive days followed by 7 days off treatment) + anastrozole placebo (1 mg, PO, once daily)

Arm Title

Anastrozole + palbociclib

Arm Type

Active Comparator

Arm Description

The patients will recieve Anastrozole (1 mg, PO, once daily) + palbociclib (PO, once daily, 125 mg for 21 consecutive days followed by 7 days off treatment) + AZD9833 placebo (PO, once daily)

Intervention Type

Drug

Intervention Name(s)

AZD9833

Intervention Description

Dosage formulation: AZD9833 tablets will be administered orally

Intervention Type

Drug

Intervention Name(s)

Anastrozole

Intervention Description

Dosage formulation: Anastrozole tablets will be administered orally.

Intervention Type

Drug

Intervention Name(s)

Anastrozole placebo

Intervention Description

Dosage formulation: anastrozole placebo tablets will be administrated orally.

Intervention Type

Drug

Intervention Name(s)

AZD9833 placebo

Intervention Description

Dosage formulation: AZD9833 placebo tablets will be administrated orally.

Intervention Type

Drug

Intervention Name(s)

Palbociclib

Intervention Description

Dosage formulation: palbociclib tablets/capsules will be administered orally

Intervention Type

Drug

Intervention Name(s)

Luteinizing hormone-releasing hormone (LHRH) agonist

Intervention Description

Men (when medically applicable) and pre- or peri-menopausal women are required to receive a monthly LHRH agonist.

Primary Outcome Measure Information:

Title

Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1

Description

PFS is defined as the time from randomization to objective disease progression (as assessed by RECIST) or death.

Time Frame

From randomization until progression per RECIST 1.1 as assessed by the investigator at local site or death due to any cause (up to 5 years)

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

The OS is defined as the time from randomization to death due to any cause.

Time Frame

From randomization until the date of death due to any cause (up to 8 years)

Title

Second progression-free survival (PFS2)

Description

Time Frame

From randomization to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death (up to 5 years)

Title

Objective response rate (ORR) assessed by the Investigator as defined by RECIST version 1.1

Description

ORR is defined as the proportion of patients who have a CR or partial response, as determined by the investigator at local site per RECIST 1.1.

Time Frame

From randomization until a response or in the absence of a response from randomization up until progression, or the last evaluable assessment in the absence of progression (up to 5 years)

Title

Duration of response (DoR) assessed by the Investigator as defined by RECIST version 1.1

Description

The DoR will be defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression.

Time Frame

From the date of first documented response until date of documented progression per RECIST 1.1 as assessed by the investigator at local site or death due to any cause (up to 5 years)

Title

Time to chemotherapy (TTC)

Description

Time to chemotherapy is defined as the time from randomization until the earlier of the start date of chemotherapy or death due to any cause.

Time Frame

From randomization until the earlier of the start date of chemotherapy or death due to any cause (up to 5 years)

Title

Time to first subsequent anti-cancer therapy (TFST)

Description

TFST is defined as time from randomization until the earlier of start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment, or death due to any cause.

Time Frame

From randomization until the earlier of start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment, or death due to any cause (up to 5 years)

Title

Clinical benefit rate at 24 weeks (CBR24)

Description

Time Frame

At least 23 weeks after randomisation

Title

Time to second subsequent therapy (TSST)

Description

TSST is defined as time from randomization until the earlier of start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment, or death due to any cause.

Time Frame

From randomization until the earlier of start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment, or death due to any cause (up to 5 years)

Title

Plasma concentration of AZD9833 at specified timepoints

Description

Time Frame

on Day 15

Title

Change from baseline in EORTC QLQ-C30 scale scores

Description

Time Frame

From baseline to 24 weeks post progression (up to approximately 5 years)

Title

Change from baseline in EORTC QLQ-BR45 scale scores

Description

Time Frame

From baseline to 24 weeks post progression (up to approximately 5 years)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

130 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA Full list of inclusion criteria Pre-/peri-menopausal women or men can be enrolled if amenable to be treated with concomitant, approved LHRH agonists for the duration of the study treatment. De novo Stage 4 disease, or recurrence from early stage disease after at least 24 months of standard adjuvant endocrine therapy. Note that at least 12 months must have elapsed since the patient's last dose of adjuvant AI therapy without disease progression on treatment. Note that a 2-week washout period is required after the last dose of tamoxifen prior to randomisation. Histologically or cytologically documented diagnosis of ER+, HER2-negative breast cancer based on local laboratory results. Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease. Measurable disease as defined per RECIST v.1.1 OR at least one lytic or mixed (lytic + sclerotic) bone lesion with a soft tissue component that can be assessed by CT or MRI. Eastern Cooperative Oncology Group performance status of 0 or 1. Adequate organ and marrow function. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. INFORMATION FOR TRIAL PARTICIPANTS Participants can join the trial if they: Have breast cancer that cannot be treated with surgery or radiation Have breast cancer that has already spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of a standard endocrine treatment Have ER proteins but not overexpression of HER2 protein in their tumors Have never received any type of cancer therapy that affects the whole body for advanced breast cancer Are able to do their daily activities EXCLUSION CRITERIA Full list of exclusion criteria Previous neoadjuvant or adjuvant treatment with an AI treatment +/- CDK4/6 inhibitor with disease recurrence while on or within 12 months of completing treatment. Prior exposure to AZD9833, other investigational SERDs/endocrine agents or fulvestrant. Participation in another clinical study with a study treatment or investigational medicinal device administered in the last 4 weeks prior to randomization or concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study. Advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term and/or impending visceral crisis Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease. Any clinically important and symptomatic heart disease . Currently pregnant (confirmed with positive pregnancy test) or breast-feeding. As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, renal transplant and active bleeding diseases) which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol. Any concurrent anti-cancer treatment. Active infection including tuberculosis, HBV and HCV. INFORMATION FOR TRIAL PARTICIPANTS Participants cannot join the trial if they: Have uncontrolled cancer that has spread to the brain or the spinal cord Have received certain treatments for cancer in the past but the cancer came back within 1 year Had certain types of tumors in the past, which the study doctors think could come back Are currently taking any treatment for cancer or are taking medications or supplements that affect certain proteins in the body Have any major health problem, infection, or surgery that could make it difficult or dangerous to participate in this trial, such as tuberculosis, HIV, heart problems, or a kidney transplant The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

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

AZ Breast Cancer Study Navigators

Phone

+1-877-400-4656

AstraZeneca@CareboxHealth.com

Facility Information:

Facility Name

Research Site

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36604

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

Harbor City

State/Province

California

ZIP/Postal Code

90710

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Solvang

State/Province

California

ZIP/Postal Code

93463

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Lone Tree

State/Province

Colorado

ZIP/Postal Code

80124

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33901-8101

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

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

Evergreen Park

State/Province

Illinois

ZIP/Postal Code

60805

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Urbana

State/Province

Illinois

ZIP/Postal Code

61801

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Dyer

State/Province

Indiana

ZIP/Postal Code

46311

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46845

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40513

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

Recruiting

Facility Name

Research Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Silver Spring

State/Province

Maryland

ZIP/Postal Code

20904

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

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Hattiesburg

State/Province

Mississippi

ZIP/Postal Code

39401

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39213

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

Omaha

State/Province

Nebraska

ZIP/Postal Code

68130

Country

United States

Individual Site Status

Recruiting

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

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28806

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58102

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

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

Not yet 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

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29607

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

Recruiting

Facility Name

Research Site

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57105

Country

United States

Individual Site Status

Terminated

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

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

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

Recruiting

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Irving

State/Province

Texas

ZIP/Postal Code

75063

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Tyler

State/Province

Texas

ZIP/Postal Code

75702

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

Recruiting

Facility Name

Research Site

City

Everett

State/Province

Washington

ZIP/Postal Code

98201

Country

United States

Individual Site Status

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

Renton

State/Province

Washington

ZIP/Postal Code

98055

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26505

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Feldkirch

ZIP/Postal Code

6807

Country

Austria

Individual Site Status

Recruiting

Facility Name

Research Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Individual Site Status

Recruiting

Facility Name

Research Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Individual Site Status

Recruiting

Facility Name

Research Site

City

Wien

ZIP/Postal Code

1130

Country

Austria

Individual Site Status

Recruiting

Facility Name

Research Site

City

Anderlecht

ZIP/Postal Code

1070

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

Leuven

ZIP/Postal Code

3000

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

Panagyurishte

ZIP/Postal Code

4500

Country

Bulgaria

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Research Site

City

Plovdiv

ZIP/Postal Code

4109

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Research Site

City

Shumen

ZIP/Postal Code

9700

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1303

Country

Bulgaria

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1330

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1527

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Research Site

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Individual Site Status

Recruiting

Facility Name

Research Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1H7

Country

Canada

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2G 1G3

Country

Canada

Individual Site Status

Recruiting

Facility Name

Research Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

Individual Site Status

Recruiting

Facility Name

Research Site

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3E 5J1

Country

Canada

Individual Site Status

Withdrawn

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

Chicoutimi

ZIP/Postal Code

G7H 5H6

Country

Canada

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Montreal

ZIP/Postal Code

H3T 1E2

Country

Canada

Individual Site Status

Recruiting

Facility Name

Research Site

City

Concepcion

ZIP/Postal Code

4070196

Country

Chile

Individual Site Status

Recruiting

Facility Name

Research Site

City

La Serena

ZIP/Postal Code

1720430

Country

Chile

Individual Site Status

Recruiting

Facility Name

Research Site

City

Puerto Montt

ZIP/Postal Code

5500243

Country

Chile

Individual Site Status

Recruiting

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

7630370

Country

Chile

Individual Site Status

Recruiting

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

8241479

Country

Chile

Individual Site Status

Recruiting

Facility Name

Research Site

City

Temuco

ZIP/Postal Code

4810218

Country

Chile

Individual Site Status

Recruiting

Facility Name

Research Site

City

Baoding

ZIP/Postal Code

071000

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Beijing

ZIP/Postal Code

100039

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

Beijing

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

130000

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

410013

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Chengdu

ZIP/Postal Code

610042

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

400042

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Dalian

ZIP/Postal Code

116011

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

Guiyang

ZIP/Postal Code

550004

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

Recruiting

Facility Name

Research Site

City

Hangzhou

ZIP/Postal Code

310020

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Hangzhou

ZIP/Postal Code

310022

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Hefei

ZIP/Postal Code

230031

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Jinan

ZIP/Postal Code

2501117

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Lanzhou

ZIP/Postal Code

730000

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Linyi

ZIP/Postal Code

276000

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

Qingdao

ZIP/Postal Code

266071

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

Shanghai

ZIP/Postal Code

200433

Country

China

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Shenyang

ZIP/Postal Code

110001

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Tianjin

ZIP/Postal Code

300060

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Urumqi

ZIP/Postal Code

830000

Country

China

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Wuhan

ZIP/Postal Code

430000

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

Xi'an

ZIP/Postal Code

710061

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Zhengzhou

ZIP/Postal Code

450008

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Horovice

ZIP/Postal Code

268 01

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Novy Jicin

ZIP/Postal Code

741 01

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Olomouc

ZIP/Postal Code

77900

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Praha 4

ZIP/Postal Code

140 00

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Praha 5

ZIP/Postal Code

150 06

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Besancon Cedex

ZIP/Postal Code

25030

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Bordeaux

ZIP/Postal Code

33030

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Brest Cedex

ZIP/Postal Code

29609

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Caen Cedex 05

ZIP/Postal Code

14076

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Dijon

ZIP/Postal Code

21079

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Le Mans

ZIP/Postal Code

72000

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Lille

ZIP/Postal Code

59000

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Montpellier

ZIP/Postal Code

34070

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Pierre Benite Cedex

ZIP/Postal Code

69495

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Plerin SUR MER

ZIP/Postal Code

22190

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Saint-cloud

ZIP/Postal Code

92210

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

Berlin

ZIP/Postal Code

13125

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Bottrop

ZIP/Postal Code

46236

Country

Germany

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Dessau-RoBlau

ZIP/Postal Code

06847

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Essen

ZIP/Postal Code

45136

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Freiburg

ZIP/Postal Code

79110

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

81675

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Münster

ZIP/Postal Code

48145

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Velbert

ZIP/Postal Code

42551

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

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1088

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Research Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Győr

ZIP/Postal Code

9024

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Research Site

City

Miskolc

ZIP/Postal Code

3526

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Research Site

City

Nyíregyháza

ZIP/Postal Code

4400

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Research Site

City

Szekszárd

ZIP/Postal Code

7100

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Research Site

City

Tatabánya

ZIP/Postal Code

2800

Country

Hungary

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Research Site

City

Ahmedabad

ZIP/Postal Code

380060

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Bangalore

ZIP/Postal Code

560027

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Calicut

ZIP/Postal Code

673601

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Delhi

ZIP/Postal Code

110085

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Faridabad

ZIP/Postal Code

121001

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Gurgaon

ZIP/Postal Code

122001

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Karamsad

ZIP/Postal Code

388325

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kolkata

ZIP/Postal Code

700160

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Madurai

ZIP/Postal Code

625107

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Mumbai

ZIP/Postal Code

400053

Country

India

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Nagpur

ZIP/Postal Code

440001

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Nashik

ZIP/Postal Code

422009

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Nashik

ZIP/Postal Code

422011

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

New Delhi

ZIP/Postal Code

11029

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Bergamo

ZIP/Postal Code

24127

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Firenze

ZIP/Postal Code

50139

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Genova

ZIP/Postal Code

16132

Country

Italy

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Milan

ZIP/Postal Code

20141

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Misterbianco

ZIP/Postal Code

95045

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Modena

ZIP/Postal Code

41124

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

Novara

ZIP/Postal Code

28100

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

Parma

ZIP/Postal Code

43100

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Prato

ZIP/Postal Code

59100

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

Roma

ZIP/Postal Code

161

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

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

Chuo-ku

ZIP/Postal Code

862-8655

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Fukushima-shi

ZIP/Postal Code

960-1295

Country

Japan

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Hidaka-shi

ZIP/Postal Code

350-1298

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Hirakata-shi

ZIP/Postal Code

573-1191

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

Kitaadachi-gun

ZIP/Postal Code

362-0806

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Koto-ku

ZIP/Postal Code

135-8550

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kumamoto-shi

ZIP/Postal Code

860-8556

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kurashiki shi

ZIP/Postal Code

701 0192

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kurume-shi

ZIP/Postal Code

830-0013

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kyoto-shi

ZIP/Postal Code

606-8507

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

467-0001

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Nishinomiya-shi

ZIP/Postal Code

663-8501

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Osaka-shi

ZIP/Postal Code

540-0006

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

Recruiting

Facility Name

Research Site

City

Sagamihara-shi

ZIP/Postal Code

252-0375

Country

Japan

Individual Site Status

Withdrawn

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

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Shimotsuke-shi

ZIP/Postal Code

329-0498

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Shinagawa-ku

ZIP/Postal Code

142-8666

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Shinjuku-ku

ZIP/Postal Code

162-8655

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Suita-shi

ZIP/Postal Code

565-0871

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Takasaki-shi

ZIP/Postal Code

370-0829

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Tsu-shi

ZIP/Postal Code

514-8507

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Tsukuba-shi

ZIP/Postal Code

305-8576

Country

Japan

Individual Site Status

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

49201

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

Incheon

ZIP/Postal Code

22332

Country

Korea, Republic of

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03080

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

George Town

ZIP/Postal Code

10450

Country

Malaysia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Johor Bahru

ZIP/Postal Code

81100

Country

Malaysia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kuala Lumpur

ZIP/Postal Code

50586

Country

Malaysia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kuching

ZIP/Postal Code

93586

Country

Malaysia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Selangor

ZIP/Postal Code

62250

Country

Malaysia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Del. Cuauhtemoc

ZIP/Postal Code

06700

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Research Site

City

Estado de México

ZIP/Postal Code

50080

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Research Site

City

La Paz

ZIP/Postal Code

23040

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Research Site

City

Metepec

ZIP/Postal Code

52140

Country

Mexico

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Mexico City

ZIP/Postal Code

0 3100

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Research Site

City

MEX

ZIP/Postal Code

14080

Country

Mexico

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Monterrey

ZIP/Postal Code

64710

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Research Site

City

Puebla

ZIP/Postal Code

72424

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Research Site

City

Drammen

ZIP/Postal Code

3004

Country

Norway

Individual Site Status

Recruiting

Facility Name

Research Site

City

Oslo

ZIP/Postal Code

N-0379

Country

Norway

Individual Site Status

Recruiting

Facility Name

Research Site

City

Bydgoszcz

ZIP/Postal Code

85-796

Country

Poland

Individual Site Status

Recruiting

Facility Name

Research Site

City

Gdynia

ZIP/Postal Code

81-519

Country

Poland

Individual Site Status

Recruiting

Facility Name

Research Site

City

Konin

ZIP/Postal Code

62-500

Country

Poland

Individual Site Status

Recruiting

Facility Name

Research Site

City

Koszalin

ZIP/Postal Code

75-581

Country

Poland

Individual Site Status

Recruiting

Facility Name

Research Site

City

Lublin

ZIP/Postal Code

20-090

Country

Poland

Individual Site Status

Recruiting

Facility Name

Research Site

City

Olsztyn

ZIP/Postal Code

10-513

Country

Poland

Individual Site Status

Terminated

Facility Name

Research Site

City

Poznan

ZIP/Postal Code

60-693

Country

Poland

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Skórzewo

ZIP/Postal Code

60-185

Country

Poland

Individual Site Status

Recruiting

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

02-034

Country

Poland

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Łódź

ZIP/Postal Code

90-302

Country

Poland

Individual Site Status

Recruiting

Facility Name

Research Site

City

Braga

ZIP/Postal Code

4710

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Research Site

City

Guimarães

ZIP/Postal Code

4835-044

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Research Site

City

Lisboa

ZIP/Postal Code

1400-038

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Research Site

City

Lisboa

ZIP/Postal Code

1500-650

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Research Site

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Research Site

City

Lisboa

ZIP/Postal Code

1998-018

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Research Site

City

Loures

ZIP/Postal Code

2674-514

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Research Site

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Research Site

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Research Site

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Vila Nova de Gaia

ZIP/Postal Code

4434-502

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kaluga

ZIP/Postal Code

248007

Country

Russian Federation

Individual Site Status

Suspended

Facility Name

Research Site

City

Kislino Village, Ryshkovsky Ru

ZIP/Postal Code

305524

Country

Russian Federation

Individual Site Status

Completed

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

111123

Country

Russian Federation

Individual Site Status

Suspended

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Individual Site Status

Suspended

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

117997

Country

Russian Federation

Individual Site Status

Suspended

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

121467

Country

Russian Federation

Individual Site Status

Suspended

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Individual Site Status

Suspended

Facility Name

Research Site

City

Saint-Petersburg

ZIP/Postal Code

190103

Country

Russian Federation

Individual Site Status

Suspended

Facility Name

Research Site

City

Saint-Petersburg

ZIP/Postal Code

195067

Country

Russian Federation

Individual Site Status

Suspended

Facility Name

Research Site

City

Sankt-Peterburg

ZIP/Postal Code

196603

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Banská Bystrica

ZIP/Postal Code

974 01

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Bratislava

ZIP/Postal Code

81250

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Bratislava

ZIP/Postal Code

833 01

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Košice

ZIP/Postal Code

041 91

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Prešov

ZIP/Postal Code

081 81

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Trencin

ZIP/Postal Code

91171

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Trnava

ZIP/Postal Code

91708

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Žilina

ZIP/Postal Code

012 07

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

08908

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

Jaén

ZIP/Postal Code

23007

Country

Spain

Individual Site Status

Recruiting

Facility Name

Research Site

City

Lleida

ZIP/Postal Code

25198

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

28046

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

Pamplona

ZIP/Postal Code

31008

Country

Spain

Individual Site Status

Recruiting

Facility Name

Research Site

City

Santander

ZIP/Postal Code

39008

Country

Spain

Individual Site Status

Recruiting

Facility Name

Research Site

City

Sevilla

ZIP/Postal Code

41013

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

Valencia

ZIP/Postal Code

46015

Country

Spain

Individual Site Status

Recruiting

Facility Name

Research Site

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Liestal

ZIP/Postal Code

CH- 4410

Country

Switzerland

Individual Site Status

Recruiting

Facility Name

Research Site

City

Zürich

ZIP/Postal Code

8008

Country

Switzerland

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kaohsiung

ZIP/Postal Code

82445

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kaohsiung

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

40443

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Taipei City

ZIP/Postal Code

110

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

10048

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

104

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

235

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

Adana

ZIP/Postal Code

01120

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06010

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06230

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06340

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

6100

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Research Site

City

İstanbul

ZIP/Postal Code

34457

Country

Turkey

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Research Site

City

Izmir

ZIP/Postal Code

35620

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kayseri

ZIP/Postal Code

38039

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Research Site

City

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

Cambridge

ZIP/Postal Code

CB2 2QQ

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

Colchester

ZIP/Postal Code

CO4 5JL

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

Northwood

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Nottingham

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

Surrey

ZIP/Postal Code

GU2 7XX

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

Swansea

ZIP/Postal Code

SA2 8QA

Country

United Kingdom

Individual Site Status

Withdrawn

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 request 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 deidentified 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

Links:

URL

https://breastcancerstudylocator.com/

Description

BreastCancerStudyLocator.com

Learn more about this trial

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A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease (SERENA-4)

ER-Positive HER2-Negative 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