RecruitingPhase 3NCT06380751

Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer

A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)


Sponsor

AstraZeneca

Enrollment

500 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new combination of two targeted drugs — saruparib (AZD5305) and camizestrant — for patients with advanced breast cancer that is hormone-receptor-positive (HR+), HER2-negative, and carries a mutation in the BRCA1, BRCA2, or PALB2 gene. **You may be eligible if...** - You are an adult (male or female, any menopausal status) - You have HR-positive, HER2-negative advanced or metastatic breast cancer - You have a confirmed inherited mutation in BRCA1, BRCA2, or PALB2 - Your cancer cannot be cured with surgery - You are in good general health (ECOG 0-1) - Your organ function is adequate **You may NOT be eligible if...** - You have a history of or signs of a bone marrow disorder (MDS/AML) - You have a known tendency to bleed severely - You have uncontrolled serious medical conditions - Your blood counts are severely low Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSaruparib (AZD5305)

Saruparib (AZD5305) is a potent and selective inhibitor of PARP1, with minimal effect on PARP2.

DRUGCamizestrant

Camizestrant (AZD9833) is an orally bioavailable, next generation SERD with non-clinical and clinical activity in both ESR1 mutant and wild type settings .

DRUGAbemaciclib

CDK4/6 Inhibitor

DRUGRibociclib

CDK4/6 Inhibitor

DRUGPalbociclib

CDK 4/6 Inhibitor

DRUGFulvestrant

Endocrine Therapy

DRUGLetrozole

Endorcine Therapy

DRUGAnastrozole

Endocrine Therapy

DRUGExemestane

Endocrine Therapy


Locations(298)

Research Site

Gilbert, Arizona, United States

Research Site

Fountain Valley, California, United States

Research Site

Glendale, California, United States

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Los Angeles, California, United States

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Newport Beach, California, United States

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Aurora, Colorado, United States

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Grand Junction, Colorado, United States

Research Site

Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Orlando, Florida, United States

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Chicago, Illinois, United States

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Evanston, Illinois, United States

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Park Ridge, Illinois, United States

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Urbana, Illinois, United States

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Winfield, Illinois, United States

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Indianapolis, Indiana, United States

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Louisville, Kentucky, United States

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Baltimore, Maryland, United States

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Silver Spring, Maryland, United States

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Silver Spring, Maryland, United States

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Boston, Massachusetts, United States

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Dearborn, Michigan, United States

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Detroit, Michigan, United States

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Royal Oak, Michigan, United States

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Royal Oak, Michigan, United States

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Rochester, Minnesota, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Camden, New Jersey, United States

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New Brunswick, New Jersey, United States

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Brooklyn, New York, United States

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Mineola, New York, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Shirley, New York, United States

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Stony Brook, New York, United States

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The Bronx, New York, United States

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Westbury, New York, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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West Columbia, South Carolina, United States

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Chattanooga, Tennessee, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Norfolk, Virginia, United States

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Tacoma, Washington, United States

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Morgantown, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Ciudad Autónoma Buenos Aires, Argentina

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Ciudad de Buenos Aires, Argentina

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Ciudad de Buenos Aires, Argentina

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Córdoba, Argentina

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Rosario, Argentina

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Salta, Argentina

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San Miguel de Tucumán, Argentina

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Darlinghurst, Australia

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Darlinghurst, Australia

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Malvern, Australia

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Melbourne, Australia

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Graz, Austria

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Innsbruck, Austria

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Linz, Austria

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Vienna, Austria

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Cachoeira de Itapemirim, Brazil

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Curitiba, Brazil

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Fortaleza, Brazil

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Goiânia, Brazil

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Jaú, Brazil

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Porto Alegre, Brazil

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Ribeirão Preto, Brazil

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Salvador, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Plovdiv, Bulgaria

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Sofia, Bulgaria

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Stara Zagora, Bulgaria

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Vratsa, Bulgaria

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Toronto, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Toronto, Canada

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Providencia, Chile

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Recoleta, Chile

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Santiago, Chile

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Talca, Chile

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Viña del Mar, Chile

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Beijing, China

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Bengbu, China

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Changchun, China

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Changchun, China

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Changsha, China

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Changsha, China

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Chengdu, China

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Chengdu, China

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Chongqing, China

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Foshan, China

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Fuzhou, China

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Guangzhou, China

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Guangzhou, China

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Guangzhou, China

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Hangzhou, China

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Hangzhou, China

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Harbin, China

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Hefei, China

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Hohhot, China

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Jining, China

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Kunming, China

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Liuzhou, China

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Luoyang, China

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Nanchang, China

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Nanchang, China

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Nanjing, China

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Shandong, China

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Shanghai, China

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Shanghai, China

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Shenyang, China

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Shijiazhuang, China

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Tianjin, China

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Weifang, China

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Wuhan, China

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Wuhan, China

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Wuhan, China

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Xi'an, China

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Xi'an, China

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Xiamen, China

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Xiangyang, China

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Xinxiang, China

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Zhengzhou, China

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Brno, Czechia

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Hořovice, Czechia

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Hradec Králové, Czechia

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Olomouc, Czechia

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Prague, Czechia

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Prague, Czechia

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Angers, France

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Besançon, France

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Lille, France

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Lyon, France

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Marseille, France

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Paris, France

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Rouen, France

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Saint-Herblain, France

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Toulouse, France

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Villejuif, France

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Aachen, Germany

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Augsburg, Germany

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Berlin, Germany

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Cologne, Germany

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Dessau, Germany

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Düsseldorf, Germany

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Erlangen, Germany

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Göttingen, Germany

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Hamburg, Germany

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Hanover, Germany

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Heidelberg, Germany

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Kiel, Germany

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Leipzig, Germany

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Ludwigsburg, Germany

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München, Germany

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Münster, Germany

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Hong Kong, Hong Kong

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Hong Kong, Hong Kong

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Budapest, Hungary

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Budapest, Hungary

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Budapest, Hungary

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Debrecen, Hungary

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Miskolc, Hungary

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Zalaegerszeg, Hungary

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Delhi, India

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Kolkata, India

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Lucknow, India

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Mumbai, India

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Mumbai, India

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Mysuru, India

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Nagpur, India

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Nashik, India

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New Delhi, India

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Surat, India

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Thiruvananthapuram, India

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Jerusalem, Israel

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Jerusalem, Israel

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Petah Tikva, Israel

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Ramat Gan, Israel

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Tel Aviv, Israel

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Bergamo, Italy

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Bologna, Italy

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Milan, Italy

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Milan, Italy

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Modena, Italy

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Naples, Italy

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Padova, Italy

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Reggio Emilia, Italy

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Rome, Italy

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Rozzano, Italy

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Chiba, Japan

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Hidaka-shi, Japan

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Hirakata-shi, Japan

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Isehara-shi, Japan

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Kagoshima, Japan

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Kashiwa, Japan

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Kōtoku, Japan

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Kumamoto, Japan

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Kyoto, Japan

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Matsuyama, Japan

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Nagoya, Japan

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Nagoya, Japan

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Nagoya, Japan

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Osaka, Japan

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Ota-shi, Japan

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Sapporo, Japan

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Sendai, Japan

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Shinagawa-ku, Japan

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Suita-shi, Japan

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Sunto-gun, Japan

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Takasaki-shi, Japan

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Tsu, Japan

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Yokohama, Japan

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Bandar Puncak Alam, Malaysia

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Johor Bahru, Malaysia

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Kuala Lumpur, Malaysia

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Kuala Selangor, Malaysia

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Malacca, Malaysia

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Bellavista, Peru

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Jesus Maria, Lima, Peru

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Lima, Peru

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Lima, Peru

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Biała Podlaska, Poland

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Koszalin, Poland

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Lodz, Poland

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Lublin, Poland

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Poznan, Poland

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Poznan, Poland

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Radom, Poland

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Warsaw, Poland

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Coimbra, Portugal

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Lisbon, Portugal

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Lisbon, Portugal

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Matosinhos Municipality, Portugal

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Porto, Portugal

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Vila Real, Portugal

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San Juan, Puerto Rico

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Daegu, South Korea

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Seongnam-si, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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A Coruña, Spain

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Barcelona, Spain

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Cáceres, Spain

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Granada, Spain

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L'Hospitalet de Llobregat, Spain

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Madrid, Spain

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Madrid, Spain

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Málaga, Spain

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Pamplona, Spain

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Seville, Spain

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Valencia, Spain

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Zaragoza, Spain

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New Taipei City, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taoyuan, Taiwan

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Bangkok, Thailand

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Bangkok, Thailand

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Dusit, Thailand

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Hat Yai, Thailand

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Muang, Thailand

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Ratchathewi, Thailand

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Ratchathewi, Thailand

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Adapazarı, Turkey (Türkiye)

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Altındağ-Ankara, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Çankaya, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Kayseri, Turkey (Türkiye)

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Cambridge, United Kingdom

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Guildford, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Oxford, United Kingdom

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Swansea, United Kingdom

Research Site

Taunton, United Kingdom

Research Site

Truro, United Kingdom

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NCT06380751


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