New hope for tough breast cancers: major trial launches

NCT ID NCT06112379

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This large Phase 3 trial tests whether a new combination of drugs (datopotamab deruxtecan plus durvalumab) given before and after surgery works better than the current standard treatment for people with untreated triple-negative or hormone receptor-low/HER2-negative breast cancer. About 1,900 adults with stage II or III breast cancer will take part. The main goal is to see if the new approach helps keep cancer from coming back.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,902 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Sep 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant must be ≥ 18 years, at the time of signing the ICF. * Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC or hormone receptor-low/HER2-negative breast cancer * ECOG PS of 0 or 1 * Provision of acceptable tumor sample * Adequate bone marrow reserve and organ function * Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and aligned with protocol requirements. Exclusion criteria: * History of any prior invasive breast malignancy * History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 5 years before randomization. * active or prior documented autoimmune or inflammatory disorders. * Evidence of distant disease. * Clinically significant corneal disease. * Has active or uncontrolled hepatitis B or C virus infection. * Known HIV infection that is not well controlled. * Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals; suspected infections; or inability to rule out infections. * Known to have active tuberculosis infection * Mean resting corrected QTcF interval \> 470 ms obtained from ECG * Uncontrolled or significant cardiac disease. * History of non-infectious ILD/pneumonitis * Has severe pulmonary function compromise * Any prior or concurrent surgery, radiotherapy or systemic anticancer therapy for TNBC or hormone receptor-low/HER2-negative breast cancer * For females only: is pregnant (confirmed with positive serum pregnancy test) or breastfeeding, or planning to become pregnant. * Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of study intervention, or as dictated by local PI for SoC if longer. * Concurrent use of systemic hormone replacement therapy or oral hormonal contraception

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

Research Site

Daphne, Alabama, 36526, United States
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Prescott, Arizona, 86301, United States
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Jonesboro, Arkansas, 72401, United States
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Rogers, Arkansas, 72758, United States
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Los Angeles, California, 90033, United States
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Santa Barbara, California, 93105, United States
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Santa Rosa, California, 92805, United States
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Torrance, California, 90505, United States
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Aurora, Colorado, 80045, United States
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Longmont, Colorado, 80504, United States
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Bridgeport, Connecticut, 06606, United States
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New Haven, Connecticut, 06510, United States
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Fort Myers, Florida, 33901, United States
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Jacksonville, Florida, 32256, United States
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St. Petersburg, Florida, 33705, United States
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West Palm Beach, Florida, 33401, United States
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Atlanta, Georgia, 30342, United States
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Des Moines, Iowa, 50309, United States
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Edgewood, Kentucky, 41017, United States
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Louisville, Kentucky, 40202, United States
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Baton Rouge, Louisiana, 70817, United States
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Annapolis, Maryland, 21401, United States
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Boston, Massachusetts, 02215, United States
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Grand Rapids, Michigan, 49503, United States
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Traverse City, Michigan, 49684, United States
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Burnsville, Minnesota, 55337, United States
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Minneapolis, Minnesota, 55407, United States
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Columbia, Missouri, 65212, United States
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Omaha, Nebraska, 68130, United States
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East Brunswick, New Jersey, 08816, United States
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New Brunswick, New Jersey, 08901, United States
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Santa Fe, New Mexico, 87505, United States
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New York, New York, 10065, United States
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Charlotte, North Carolina, 28204, United States
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Durham, North Carolina, 27710, United States
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Winston-Salem, North Carolina, 27103, United States
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Blue Ash, Ohio, 45242, United States
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Eugene, Oregon, 97401, United States
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Portland, Oregon, 97223, United States
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Philadelphia, Pennsylvania, 19104, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37203, United States
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Austin, Texas, 78731, United States
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Dallas, Texas, 75231, United States
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Dallas, Texas, 75235, United States
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Dallas, Texas, 75390-8843, United States
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El Paso, Texas, 79902, United States
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Flower Mound, Texas, 75028, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78240, United States
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Webster, Texas, 77598, United States
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Fairfax, Virginia, 22031, United States
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Norfolk, Virginia, 23502, United States
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Roanoke, Virginia, 24014, United States
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Winchester, Virginia, 22601, United States
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Tacoma, Washington, 98405, United States
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East Melbourne, 3002, Australia
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Feldkirch, 6807, Austria
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Innsbruck, 6020, Austria
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Linz, 4010, Austria
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Salzburg, 5020, Austria
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Antwerp, 2020, Belgium
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Brasschaat, 2930, Belgium
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Charleroi, 6060, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Libramont-Chevigny, 6800, Belgium
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Brasília, 71681-603, Brazil
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Curitiba, 80440-220, Brazil
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Fortaleza, 60336-045, Brazil
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Londrina, 86015-520, Brazil
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Natal, 59075-740, Brazil
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Porto Alegre, 90035-000, Brazil
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Porto Alegre, 90035-903, Brazil
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Ribeirão Preto, 14051-140, Brazil
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Santo André, 09060-650, Brazil
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São Paulo, 01246-000, Brazil
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Taubaté, 12030-200, Brazil
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Vitória, 29043-260, Brazil
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Shumen, 9700, Bulgaria
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Sofia, 1330, Bulgaria
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Sofia, Bulgaria
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Calgary, Alberta, T2N 5G2, Canada
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Vancouver, British Columbia, VSZ 4E6, Canada
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Barrie, Ontario, L4M 6M2, Canada
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London, Ontario, N6A 5W9, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Lévis, Quebec, G6V 3Z1, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H2X 0C1, Canada
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Montreal, Quebec, H4A-3J1, Canada
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Saint-Jérôme, Quebec, J7Z 5T3, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Montreal, H3T 1E2, Canada
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Ottawa, K1H 8L6, Canada
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Beijing, 100044, China
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Bengbu, 233004, China
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Changchun, 130021, China
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Changsha, 410008, China
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Chengdu, 610000, China
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Guangzhou, 510060, China
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Guangzhou, 510120, China
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Hangzhou, 310009, China
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Hangzhou, 310022, China
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Harbin, 150049, China
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Jinan, 250117, China
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Linhai, 317000, China
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Nanchang, 330009, China
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Nanchang, 330029, China
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Nanjing, 210008, China
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Nanning, 530021, China
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Shanghai, 200025, China
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Shenyang, 110004, China
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Shijiazhuang, 050020, China
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Suining, 629000, China
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Tianjin, 300000, China
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Wuhan, 430022, China
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Xi'an, 710061, China
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Xintai, 54031, China
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Zhaoqing, 526000, China
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Zhengzhou, 450008, China
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Avignon, 84918, France
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Bayonne, 64100, France
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Caen, 41076, France
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Clermont-Ferrand, 63011, France
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Limoges, 87000, France
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Marseille, 13273, France
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Montpellier, 34298, France
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Nice, 06100, France
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Paris, 75010, France
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Reims, 51056, France
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Toulouse, 31100, France
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Vandœuvre-lès-Nancy, 54519, France
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Villejuif, 94805, France
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Augsburg, 86150, Germany
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Berlin, 10967, Germany
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Berlin, 13125, Germany
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Dessau, 06847, Germany
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Dresden, 01307, Germany
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Erlangen, 91054, Germany
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Essen, 45130, Germany
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Esslingen am Neckar, 73730, Germany
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Frankfurt am Main, 60431, Germany
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Freiburg im Breisgau, 79110, Germany
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Hamburg, 20246, Germany
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Hanover, 30559, Germany
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Heidelberg, 69120, Germany
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Kiel, 24105, Germany
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Mainz, 55131, Germany
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Mannheim, 68167, Germany
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München, 80637, Germany
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Münster, 48149, Germany
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Trier, 54290, Germany
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Ulm, 89075, Germany
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Hong Kong, 999077, Hong Kong
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Budapest, 1122, Hungary
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Kecskemét, 6000, Hungary
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Miskolc, 3526, Hungary
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Szekszárd, 7100, Hungary
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Bengaluru, 560085, India
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Delhi, 110029, India
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Delhi, 110085, India
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Kolkata, 700016, India
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Kolkata, 700099, India
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Marg Jaipur, 302004, India
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Nagpur, 440001, India
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Nashik, 422011, India
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Thiruvananthapuram, 695011, India
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Vadodara, 391760, India
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Empoli, 50053, Italy
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Lucca, 55100, Italy
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Milan, 20132, Italy
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Modena, 41124, Italy
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Naples, 80131, Italy
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Padova, 35128, Italy
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Province of Macerata, 62100, Italy
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Roma, 00168, Italy
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Rozzano, 20089, Italy
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Torino, 10126, Italy
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Tricase, 73039, Italy
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Udine, 33100, Italy
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Akashi-shi, 673-8558, Japan
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Akita, 010-8543, Japan
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Bunkyō City, 113-8431, Japan
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Chiba, 260-8717, Japan
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Chūōku, 104-0045, Japan
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Chūōku, 104-8560, Japan
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Fukuoka, 811-1395, Japan
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Fukushima, 960-1295, Japan
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Gifu, 501-1194, Japan
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Hidaka-shi, 350-1298, Japan
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Hirakata-shi, 573-1191, Japan
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Hiroshima, 730-0011, Japan
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Hiroshima, 734-8551, Japan
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Isehara-shi, 259-1193, Japan
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Kashiwa, 227-8577, Japan
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Kumamoto, 860-8556, Japan
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Kurume-shi, 830-0011, Japan
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Kyoto, 606-8507, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 460-0001, Japan
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Nagoya, 466-8560, Japan
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Nagoya, 467-0001, Japan
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Niigata, 951-8566, Japan
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Okayama, 700-8558, Japan
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Osaka, 541-8567, Japan
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Sapporo, 003-0804, Japan
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Sapporo, 060-8648, Japan
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Sendai, 980-8574, Japan
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Shinagawa-ku, 142-8666, Japan
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Shinjuku-ku, 160-0023, Japan
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Shinjuku-ku, 162-8655, Japan
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Sunto-gun, 411-8777, Japan
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Tsu, 514-8507, Japan
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Yokohama, 241-8515, Japan
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George Town, 10990, Malaysia
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Kuala Lumpur, 50586, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuala Selangor, 62250, Malaysia
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Kuching, 93586, Malaysia
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Bialystok, 15-027, Poland
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Bydgoszcz, 85-796, Poland
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Gdynia, 81-519, Poland
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Krakow, 31-501, Poland
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Lodz, 93-338, Poland
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Warsaw, 02-781, Poland
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Singapore, 168583, Singapore
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Daegu, 41404, South Korea
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Goyang-si, 10408, South Korea
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Seongnam, 13620, South Korea
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Seoul, 02841, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06273, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Barcelona, 08036, Spain
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Granada, 18016, Spain
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Hospitalet deLlobregat, 08907, Spain
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Madrid, 28007, Spain
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Madrid, 28034, Spain
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Santiago de Compostela, 15706, Spain
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Seville, 41009, Spain
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Zaragoza, 50009, Spain
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Baden, CH-5405, Switzerland
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Basel, 4031, Switzerland
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Bern, 3010, Switzerland
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Frauenfeld, 8501, Switzerland
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Changhua, 500, Taiwan
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Kaohsiung City, 82445, Taiwan
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Taichung, 40447, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 10449, Taiwan
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Taipei, 112, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10210, Thailand
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Bangkok, 10330, Thailand
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Dusit, 10300, Thailand
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Muang, 50200, Thailand
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Songkhla, 90110, Thailand
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Adapazarı, 54290, Turkey (Türkiye)
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Ankara, 06010, Turkey (Türkiye)
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Ankara, 06340, Turkey (Türkiye)
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Ankara, 06520, Turkey (Türkiye)
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Istanbul, 34722, Turkey (Türkiye)
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Kayseri, 38039, Turkey (Türkiye)
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Samsun, 55200, Turkey (Türkiye)
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Birmingham, B15 2TG, United Kingdom
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Cardiff, CF14 2TL, United Kingdom
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Lancaster, LA1 4RP, United Kingdom
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London, EC1A 7BE, United Kingdom
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Northampton, NN1 5BD, United Kingdom
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Oxford, OX3 7LE, United Kingdom
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Taunton, TA1 5DA, United Kingdom
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Hồ Chí Minh, 700000, Vietnam
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Vinh, 460000, Vietnam

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