New hope for advanced breast cancer: targeted drug duo enters final testing phase

NCT ID NCT06380751

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 6 times

Summary

This study tests a new combination of two drugs (saruparib and camizestrant) against standard treatments for advanced breast cancer that is hormone-receptor-positive and HER2-negative. It is for people with inherited BRCA1, BRCA2, or PALB2 mutations. The goal is to see if the new combo slows cancer growth better than current options. About 500 adults with advanced or metastatic breast cancer will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

About 788 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Dec 2031

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: * Adult females, pre/peri-menopausal and/or post-menopausal, and adult males * Histologically or cytologically documented diagnosis of HR-positive, HER2-negative breast cancer * Advanced breast cancer with either locally advanced disease not amenable to curative treatment or metastatic disease * ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks * FFPE tumour tissue from each participant * Documented germline tumour loss of function mutation in BRCA1, BRCA2, or PALB2 * Adequate organ and marrow function Exclusion Criteria: * Participants with history of MDS/AML or with features suggestive of MDS/AML * Participants with any known predisposition to bleeding * Any history of persisting severe cytopenia * Any evidence of severe or uncontrolled systemic diseases or active uncontrolled infections * Refractory nausea and vomiting, chronic GI disease, inability to swallow the formulated product, or previous significant bowel resection * History of another primary malignancy * Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy excluding alopecia * Spinal cord compression, brain metastases, carcinomatous meningitis, or leptomeningeal disease * Evidence of active and uncontrolled hepatitis B and/or hepatitis C * Evidence of active and uncontrolled HIV infection * Active tuberculosis infection * Cardiac criteria, including history of arrythmia and cardiovascular disease * Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy for non-cancer-related conditions * Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study * Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of the bone marrow within 4 weeks before the first dose of study treatment * Prior treatment with systemic anti-cancer therapy for locoregionally recurrent or metastatic disease is not permitted, apart from treatment with ET for up to 28 days total before randomisation * Prior treatment within 28 days with blood product support or growth factor support * Any systemic concurrent anti-cancer treatment * Concomitant use of the following types of medications or herbal supplements within 21 days or at least 5 half-lives of randomisation: 1. Strong and moderate CYP3A4 inducers/inhibitors 2. Sensitive CYP2B6 substrates 3. Substrates of CYP2C9 and/or CYP2C19 which have a narrow therapeutic index, eg, warfarin (and other coumarin-derived vitamin K antagonist anticoagulants) and phenytoin. * Concomitant use of drugs that are known to prolong QT and have a known risk of TdP * Systemic use of atropine * The following exclusion criteria apply to treatments administered for early breast cancer: 1. Disease progression ≤ 84 days following the last dose of neo-adjuvant or adjuvant chemotherapy 2. Disease progression ≤ 1 year (365 days) from the last dose of treatment with a PARPi and/or platinum agent for early breast cancer 3. Disease progression ≤ 1 year (365 days) from the last dose with a CDK4/6i in the adjuvant setting 4. Disease progression ≤ 1 year (365 days) from the last dose of an oral SERD including camizestrant.

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Conditions

The condition(s) this trial relates to.

breast cancer hormone receptor-positive breast cancer

As listed by the trial registrant

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

Advanced breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

268 sites in 29 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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Gilbert, Arizona, 85234, United States
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Fountain Valley, California, 92708, United States
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Glendale, California, 91206, United States
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Los Angeles, California, 90089, United States
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Newport Beach, California, 92663, United States
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Aurora, Colorado, 80045, United States
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Grand Junction, Colorado, 81501, United States
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Hollywood, Florida, 33021, United States
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Jacksonville, Florida, 32224, United States
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Orlando, Florida, 32806, United States
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Orlando, Florida, 32806, United States
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Arlington Heights, Illinois, 60005, United States
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Chicago, Illinois, 60611, United States
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Evanston, Illinois, 60201, United States
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Park Ridge, Illinois, 60068, United States
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Schaumburg, Illinois, 60173, United States
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Urbana, Illinois, 61801, United States
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Winfield, Illinois, 60190, United States
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Indianapolis, Indiana, 46227, United States
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Louisville, Kentucky, 40207, United States
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Baltimore, Maryland, 21201, United States
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Silver Spring, Maryland, 20902, United States
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Silver Spring, Maryland, 20904, United States
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Boston, Massachusetts, 02215, United States
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Dearborn, Michigan, 48126, United States
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Detroit, Michigan, 48202, United States
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Royal Oak, Michigan, 48073, United States
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Royal Oak, Michigan, 48073, United States
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Rochester, Minnesota, 55905, United States
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Saint Joseph, Missouri, 64507, United States
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Springfield, Missouri, 65804, United States
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St Louis, Missouri, 63110, United States
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Camden, New Jersey, 08103, United States
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New Brunswick, New Jersey, 08901, United States
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Brooklyn, New York, 11220, United States
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Mineola, New York, 11501, United States
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New Hyde Park, New York, 11042, United States
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New York, New York, 10016, United States
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New York, New York, 10028, United States
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New York, New York, 10065, United States
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Shirley, New York, 11967, United States
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Stony Brook, New York, 11790, United States
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The Bronx, New York, 10469, United States
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Westbury, New York, 11590, United States
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Hershey, Pennsylvania, 17033, United States
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Philadelphia, Pennsylvania, 19104, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Pittsburgh, Pennsylvania, 15215, United States
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West Columbia, South Carolina, 29169, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37203, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77054, United States
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San Antonio, Texas, 78240, United States
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Norfolk, Virginia, 23502, United States
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Richmond, Virginia, 23226, United States
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Tacoma, Washington, 98405, United States
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Morgantown, West Virginia, 26506, United States
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Milwaukee, Wisconsin, 53215, United States
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Ciudad Autónoma Buenos Aires, 1125, Argentina
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Ciudad de Buenos Aires, 1015, Argentina
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Ciudad de Buenos Aires, C1280AEB, Argentina
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Córdoba, 5008, Argentina
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Rosario, S2000KZE, Argentina
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Salta, A4400EMI, Argentina
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San Miguel de Tucumán, 4000, Argentina
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Darlinghurst, 2010, Australia
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Darlinghurst, 2139, Australia
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Malvern, 3144, Australia
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Melbourne, VIC 3000, Australia
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Linz, 4010, Austria
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Vienna, 1090, Austria
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Cachoeira de Itapemirim, 29308-055, Brazil
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Curitiba, 80060-900, Brazil
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Fortaleza, 60336-045, Brazil
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Goiânia, 74000-000, Brazil
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Jaú, 17210-120, Brazil
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Porto Alegre, 91350-200, Brazil
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Ribeirão Preto, 14049-901, Brazil
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Salvador, 41253-190, Brazil
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São Paulo, 01509-900, Brazil
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São Paulo, 03102-002, Brazil
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Plovdiv, 4002, Bulgaria
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Sofia, 1527, Bulgaria
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Stara Zagora, 6003, Bulgaria
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Vratsa, 3000, Bulgaria
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Toronto, Ontario, M5G 2M9, Canada
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Greenfield Park, Quebec, J4V 2G9, Canada
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Montreal, Quebec, H2X 0A9, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Saskatoon, Saskatchewan, S7N 4H4, Canada
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Toronto, M4N 3M5, Canada
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Providencia, 7500994, Chile
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Recoleta, 8420391, Chile
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Santiago, 8330034, Chile
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Talca, 3461341, Chile
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Viña del Mar, 2520000, Chile
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Beijing, 100044, China
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Bengbu, 233004, China
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Changchun, 130012, China
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Changchun, 130021, China
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Changsha, 410008, China
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Changsha, 410013, China
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Chengdu, 610000, China
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Chengdu, 610072, China
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Chongqing, 400042, China
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Foshan, 528000, China
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Fuzhou, 350014, China
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Guangzhou, 510060, China
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Guangzhou, 510062, China
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Guangzhou, 510289, China
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Hangzhou, 310016, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Hefei, 230031, China
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Hohhot, 010017, China
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Jining, 272029, China
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Kunming, 650118, China
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Liuzhou, 545006, China
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Luoyang, 471000, China
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Nanchang, 330006, China
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Nanchang, 330009, China
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Nanjing, 210029, China
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Shandong, 250117, China
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Shanghai, 200025, China
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Shanghai, 200120, China
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Shenyang, 110016, China
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Shijiazhuang, 050000, China
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Tianjin, 300000, China
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Weifang, 261000, China
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Wuhan, 430030, China
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Wuhan, 430040, China
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Wuhan, 430079, China
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Xi'an, 710006, China
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Xi'an, 710061, China
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Xiamen, 361003, China
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Xiangyang, 441000, China
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Xinxiang, 453100, China
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Zhengzhou, 450008, China
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Brno, 656 53, Czechia
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Hořovice, 26831, Czechia
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Hradec Králové, 500 05, Czechia
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Olomouc, 77900, Czechia
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Prague, 120 00, Czechia
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Prague, 180 00, Czechia
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Angers, 49100, France
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Besançon, 25030, France
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Lille, 59000, France
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Lyon, 69373, France
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Marseille, 13273, France
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Paris, 75005, France
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Rouen, 76021, France
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Saint-Herblain, 44805, France
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Toulouse, 31059, France
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Villejuif, 94805, France
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Aachen, 52074, Germany
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Augsburg, 86150, Germany
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Berlin, 13125, Germany
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Cologne, 50937, Germany
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Dessau, 06847, Germany
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Düsseldorf, 40225, Germany
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Erlangen, 91054, Germany
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Göttingen, DE-37099, Germany
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Hamburg, 20357, Germany
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Hanover, 30625, Germany
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Heidelberg, 69120, Germany
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Kiel, 24105, Germany
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Leipzig, 04103, Germany
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Ludwigsburg, 71640, Germany
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München, 81675, Germany
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Münster, 48149, Germany
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Witten, 58452, Germany
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Hong Kong, 150001, Hong Kong
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Hong Kong, 999077, Hong Kong
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NOT_YET_RECRUITING

Budapest, 1062, Hungary
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Budapest, 1082, Hungary
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Budapest, 1122, Hungary
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Budapest, 1145, Hungary
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Debrecen, 4032, Hungary
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Miskolc, 3526, Hungary
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Zalaegerszeg, 8900, Hungary
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Delhi, 110029, India
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Kolkata, 700160, India
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Lucknow, 226003, India
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Mumbai, 400012, India
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Mumbai, 400052, India
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Mysuru, 570017, India
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Nagpur, 440001, India
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Nashik, 422002, India
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New Delhi, 110085, India
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Surat, 396007, India
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Thiruvananthapuram, 695011, India
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Jerusalem, 9103102, Israel
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Jerusalem, 9112001, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 52621, Israel
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Tel Aviv, 64239, Israel
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Bergamo, 24127, Italy
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Bologna, 40138, Italy
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Milan, 20132, Italy
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Milan, 20141, 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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Reggio Emilia, 422122, Italy
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Rome, 00168, Italy
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Rozzano, 20089, Italy
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Chiba, 260-8717, Japan
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Hidaka-shi, 350-1298, Japan
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Hirakata-shi, 573-1191, Japan
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Isehara-shi, 259-1193, Japan
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Kagoshima, 892-0833, Japan
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Kashiwa, 227-8577, Japan
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Kōtoku, 135-8550, Japan
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Kumamoto, 860-8556, Japan
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Kyoto, 606-8507, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 464-8681, Japan
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Nagoya, 466-8560, Japan
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Nagoya, 467-8602, Japan
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Osaka, 541-8567, Japan
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Ota-shi, 373-8550, Japan
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Sapporo, 003-0804, Japan
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Sendai, 980-8574, Japan
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Shinagawa-ku, 142-8666, Japan
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Suita-shi, 565-0871, Japan
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Sunto-gun, 411-8777, Japan
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Takasaki-shi, 370-0829, Japan
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Tsu, 514-8507, Japan
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Yokohama, 241-8515, Japan
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Bandar Puncak Alam, 42300, Malaysia
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Johor Bahru, 81100, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuala Selangor, 62250, Malaysia
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Malacca, 75000, Malaysia
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Bellavista, CALLAO 2, Peru
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Jesus Maria, Lima, LIMA 11, Peru
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Lima, 15036, Peru
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Lima, LIMA 29, Peru
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Biała Podlaska, 21-500, Poland
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Koszalin, 75-581, Poland
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Lodz, 93-338, Poland
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Lublin, 20-090, Poland
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Poznan, 60-569, Poland
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Poznan, 61-485, Poland
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Radom, 26-600, Poland
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Warsaw, 02-781, Poland
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Coimbra, 3000-075, Portugal
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Lisbon, 1099-023, Portugal
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Lisbon, 1998-018, Portugal
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Matosinhos Municipality, 4454-509, Portugal
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Porto, 4050-115, Portugal
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Vila Real, 5000-508, Portugal
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San Juan, 00918, Puerto Rico
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Daegu, 41404, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 02841, South Korea
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Seoul, 03080, South Korea
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Seoul, 06273, South Korea
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Seoul, 06351, South Korea
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Seoul, 3722, South Korea
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Seoul, 5505, South Korea
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NOT_YET_RECRUITING

A Coruña, 15009, Spain
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Barcelona, 08035, Spain
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Cáceres, 10003, Spain
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Granada, 18007, Spain
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L'Hospitalet de Llobregat, 08908, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Málaga, 29010, Spain
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Pamplona, 31008, Spain
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Seville, 41013, Spain
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Valencia, 46006, Spain
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Zaragoza, 50009, Spain
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New Taipei City, 23561, Taiwan
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Taichung, Taiwan
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Tainan, 704, Taiwan
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Taipei, 100, Taiwan
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Taipei, 10449, Taiwan
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Taipei, 112, Taiwan
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Taoyuan, 00333, 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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Hat Yai, 90110, Thailand
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Muang, 22000, Thailand
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Ratchathewi, 10400, Thailand
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Ratchathewi, 10400, Thailand
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Adapazarı, 54290, Turkey (Türkiye)
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Altındağ-Ankara, 06230, Turkey (Türkiye)
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Ankara, 06530, Turkey (Türkiye)
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Çankaya, 06680, Turkey (Türkiye)
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Istanbul, 34214, Turkey (Türkiye)
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Kayseri, 38039, Turkey (Türkiye)
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Cambridge, CB2 2QQ, United Kingdom
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Guildford, GU2 7XX, United Kingdom
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London, SE1 9RT, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Oxford, OX3 7LE, United Kingdom
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Swansea, SA2 8QA, United Kingdom
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Taunton, TA1 5DA, United Kingdom
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Truro, TR1 3LJ, United Kingdom

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