New hope for advanced breast cancer: phase 3 trial launches

NCT ID NCT07085767

Recruiting now Disease control Sponsor: Olema Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This phase 3 trial is testing a new drug called palazestrant (OP-1250) combined with ribociclib against the standard letrozole plus ribociclib for people with ER+, HER2- advanced breast cancer who haven't had prior treatment. About 1,000 participants will be randomly assigned to one of the two combinations. The main goal is to see if the new combo slows cancer growth better than the current approach.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: palazestrant (OP-1250) and ribociclib
What this could lead to: If successful, this could offer a new first-line treatment option for people with ER+, HER2- advanced breast cancer, potentially delaying disease progression.
What could go wrong: This is a large phase 3 trial, but the experimental drug is still being tested. It may not prove better than the current standard, and side effects like low blood cell counts or liver issues are possible.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm estrogen-receptor positive breast cancer Her2-receptor negative breast cancer hormone receptor-positive breast cancer

As listed by the trial registrant

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

BREAST CANCER ER POSITIVE BREAST CANCER HER2-NEGATIVE BREAST CARCINOMA LOCALLY ADVANCED BREAST CANCER METASTATIC BREAST CANCER

Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Clinical Trial Site
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Hot Springs, Arkansas, 71913, United States
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Beverly Hills, California, 90211, United States
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La Jolla, California, 92093, United States
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Los Alamitos, California, 90720, United States
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San Francisco, California, 94115, United States
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Santa Barbara, California, 93105, United States
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Aurora, Colorado, 80045, United States
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Denver, Colorado, 80220, United States
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New Haven, Connecticut, 06511, United States
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Tampa, Florida, 33612, United States
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Marietta, Georgia, 30060, United States
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Honolulu, Hawaii, 96813, United States
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Peoria, Illinois, 61615, United States
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Urbana, Illinois, 61801, United States
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Ames, Iowa, 50010, United States
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Scarborough, Maine, 04074, United States
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Annapolis, Maryland, 21401, United States
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Minneapolis, Minnesota, 55404, United States
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Jackson, Mississippi, 39216, United States
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Kansas City, Missouri, 64132, United States
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Santa Fe, New Mexico, 87505, United States
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New York, New York, 10032, United States
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Charlotte, North Carolina, 28204, United States
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Cincinnati, Ohio, 45245, United States
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Columbus, Ohio, 43219, United States
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Horsham, Pennsylvania, 19044, United States
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Sayre, Pennsylvania, 18840, United States
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Bartlett, Tennessee, 38133, United States
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Knoxville, Tennessee, 37909, United States
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Mount Juliet, Tennessee, 37122, United States
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Nashville, Tennessee, 37232, United States
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Tennessee City, Tennessee, 37203, United States
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Denton, Texas, 76201, United States
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El Paso, Texas, 79902, United States
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Houston, Texas, 77024, United States
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San Antonio, Texas, 78229, United States
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Salt Lake City, Utah, 84106, United States
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Fort Belvoir, Virginia, 22060, United States
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Midlothian, Virginia, 32114, United States
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Norfolk, Virginia, 23502, United States
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Olympia, Washington, 98502, United States
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Vancouver, Washington, 98684, United States
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Milwaukee, Wisconsin, 52336, United States
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Sydney, New South Wales, 2109, Australia
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Waratah, New South Wales, 2298, Australia
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South Brisbane, Queensland, 4101, Australia
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Adelaide, South Australia, 5000, Australia
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Clayton, Victoria, 3168, Australia
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Geelong, Victoria, 3220, Australia
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Heidelberg, Victoria, 03084, Australia
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Nedlands, Western Australia, 6009, Australia
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Krems, Lower Austria, 3500, Austria
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Salzburg, State of Salzburg, 5020, Austria
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Linz, Upper Austria, 4010, Austria
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Brussels, Brussels Capital, 1090, Belgium
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Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium
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Kortrijk, Flanders, 8500, Belgium
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Liège, Liège Province, 4000, Belgium
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Charleroi, Wallonia, 6060, Belgium
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Toronto, Ontario, M2J 1V1, Canada
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Hořovice, Central Bohemia, 26831, Czechia
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Liberec, Liberec Region, 46001, Czechia
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Olomouc, Olomouc Region, 77900, Czechia
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Prague, Prague, 150 06, Czechia
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Zlín, Zlín, 762 75, Czechia
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Pierre-Bénite, Auvergne-Rhône-Alpes, 69310, France
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Brest, Brittany Region, 29609, France
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Plérin, Brittany Region, 22190, France
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Besançon, Doubs, 25000, France
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Montpellier, Hérault, 34070, France
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Toulouse, Occitanie, 31059, France
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Bobigny, 93000, France
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Villejuif, Île-de-France Region, 94805, France
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Frankfurt, Hassen, 60431, Germany
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Düsseldorf, North Rhine-Westphalia, 40235, Germany
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Torgau, Saxony, 04860, Germany
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Pátrai, Achaia, 26504, Greece
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Athens, Attica, 11528, Greece
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Athens, Pireas, 18547, Greece
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Thessaloniki, Thessaloniki, 57001, Greece
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Hong Kong, Hong Kong, 999077, Hong Kong
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Hong Kong, Kowloon, 999077, Hong Kong
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Hong Kong, Pok Fu Lam, 999077, Hong Kong
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Kecskemét, Bács-Kiskun county, 6000, Hungary
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Győr, Győr-Moson-Sopron, 9024, Hungary
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Debrecen, Hajdú-Bihar, 4032, Hungary
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Naples, Campania, 80131, Italy
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Bologna, Emilia-Romagna, 40138, Italy
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Aviano, Friuli Venezia Giulia, 33081, Italy
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Rome, Lazio, 168, Italy
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Genoa, Liguria, 16132, Italy
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Bergamo, Lombardy, 24127, Italy
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Milan, Lombardy, 20141, Italy
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Monza, Lombardy, 20900, Italy
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Milan, Milano, 20132, Italy
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Prato, Tuscany, 59100, Italy
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Milan, Varese, 21100, Italy
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Ipoh, Ipoh Perak, 30450, Malaysia
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Kuala Lumpur, Kuala Lumpur, 50586, Malaysia
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Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
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George Town, Pulau Pinang, 10450, Malaysia
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Kota Kinabalu, Sabah, 88996, Malaysia
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Kuching, Sarawak, 93586, Malaysia
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Petaling Jaya, Selangor, 46050, Malaysia
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Putrajaya, Wilayah PE, 62250, Malaysia
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Apeldoorn, Gelderland, 7334 DZ, Netherlands
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Maastricht, Limberg, 6202 AZ, Netherlands
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Amsterdam, North Holland, 1081 HV, Netherlands
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Krakow, Lesser Poland Voivodeship, 31-826, Poland
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Otwock, Mazowieckir, 05-400, Poland
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Rzeszów, Podkarpackie Voivodeship, 35-055, Poland
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Rzeszów, Podkarpackie Voivodeship, 35-922, Poland
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Gdansk, Pomeranian Voivodeship, 80-952, Poland
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Brzozów, Woj Podkarpackie, 36-200, Poland
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Lodz, Łódź Voivodeship, 90-302, Poland
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Lisbon, Lisbon District, 1099-023, Portugal
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Porto, Porto District, 4200-072, Portugal
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Porto, Porto District, 4464-513, Portugal
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Bucharest, Bucharest, 11171, Romania
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Cluj-Napoca, Cluj, 400641, Romania
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Ovidiu, Constanța County, 905900, Romania
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Craiova, Dolj, 200542, Romania
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Iași, Iaşi, 700106, Romania
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Timișoara, Timiș County, 300239, Romania
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Busan, Busan Metropolitan City, 49201, South Korea
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Daegu, Daegu Metropolitan City, 41404, South Korea
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Goyang-si, Gyeonggi-do, 10408, South Korea
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Seongnam-si, Gyeonggi-do, 13620, South Korea
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Suwon, Gyeonggi-do, 16247, South Korea
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Yongin-si, Gyeonggi-do, 16499, South Korea
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Seoul, Seoul, 02841, South Korea
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Seoul, Seoul, 03722, South Korea
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Seoul, Seoul Special City, 05505, South Korea
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Seoul, Seoul Special City, 08308, South Korea
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Alicante, Alicante, 3010, Spain
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Barcelona, Barcelona, 08028, Spain
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Barcelona, Barcelona, 08035, Spain
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Barcelona, Barcelona, 08036, Spain
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Granada, Granada, 18012, Spain
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León, León, 24071, Spain
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Lleida, Lleida, 25198, Spain
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Madrid, Madrid, 28007, Spain
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Madrid, Madrid, 28040, Spain
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Madrid, Madrid, 28046, Spain
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Madrid, Madrid, 28050, Spain
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Murcia, Murcia, 30120, Spain
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Seville, Sevilla, 41009, Spain
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Valencia, Valencia, 46010, Spain
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Zaragoza, Zaragoza, 50009, Spain
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Chang-hua, Chang Hua, 50006, Taiwan
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Kaohsiung City, Sanmin, 80756, Taiwan
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Taipei, Special Municipality, 11217, Taiwan
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Taipei, Special Municipality, 11490, Taiwan
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Taipei, Taipei City, 100, Taiwan
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Taipei, Taipei City, 10449, Taiwan
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Bangkok, Bangkok, 10700, Thailand
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Dusit, Bangkok, 10300, Thailand
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Ban Phaeo, Changwat Samut Sakhon, 74120, Thailand
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Hat Yai, Changwat Songkhla, 90110, Thailand
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Chiang Mai, Chiang Mai, 50200, Thailand
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Brighton, England, BN2 5BE, United Kingdom
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London, England, WC1E 6AG, United Kingdom
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London, Greater London, EC1M 6BQ, United Kingdom
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Taunton, Somerset, TA1 5DA, United Kingdom
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Guildford, Surrey, GU2 7XX, United Kingdom
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Seoul, Seoul, 03080, South Korea
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Seoul, Seoul, 03080, South Korea

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