RECRUITING Phase 3 ClinicalTrials.gov

A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

Sponsor: AstraZeneca • ClinicalTrials.gov ID: NCT05774951

Registry updated: 2026-10-13

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Description

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.

Interventions

Camizestrant (Drug)
Camizestrant. Experimental. Administered orally
Tamoxifen (Drug)
Tamoxifen. Comparator. Administered per local approved label
Anastrozole (Drug)
Anastrozole. Comparator. Administered per local approved label
Letrozole (Drug)
Letrozole. Comparator. Administered per local approved label
Exemestane (Drug)
Exemestane. Comparator. Administered per local approved label

Eligibility criteria

Inclusion Criteria: * Women and Men, ≥18 years at the time of screening (or per national guidelines) * Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with high or intermediate risk of recurrence, based on clinical-pathological risk features, as defined in the protocol. * Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy * Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor) * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 * Adequate organ and marrow function Exclusion criteria: * Inoperable locally advanced or metastatic breast cancer * Pathological complete response following treatment with neoadjuvant therapy * History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered at very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation * Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance * Known LVEF \<50% with heart failure NYHA Grade ≥2. * Mean resting QTcF interval \>480 ms at screening * Concurrent exogenous sex hormone therapy * Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors (eg, denosumab) * Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant * Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding * Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists, that would preclude the patient from receiving any LHRH agonist

Conditions

Breast Cancer, Early Breast Cancer

Locations

Research Site — Birmingham, Alabama, United States
Research Site — Dothan, Alabama, United States
Research Site — Anchorage, Alaska, United States
Research Site — Chandler, Arizona, United States
Research Site — Hot Springs, Arkansas, United States
Research Site — Anaheim, California, United States
Research Site — Beverly Hills, California, United States
Research Site — Concord, California, United States
Research Site — Corona, California, United States
Research Site — Fountain Valley, California, United States
Research Site — Greenbrae, California, United States
Research Site — Los Alamitos, California, United States
Research Site — Palo Alto, California, United States
Research Site — San Diego, California, United States
Research Site — San Diego, California, United States
Research Site — Whittier, California, United States
Research Site — Aurora, Colorado, United States
Research Site — Hartford, Connecticut, United States
Research Site — Fort Myers, Florida, United States
Research Site — Gainesville, Florida, United States
Research Site — Miami Beach, Florida, United States
Research Site — Orlando, Florida, United States
Research Site — Plantation, Florida, United States
Research Site — Port Saint Lucie, Florida, United States
Research Site — Saint Augustine, Florida, United States
Research Site — St. Petersburg, Florida, United States
Research Site — St. Petersburg, Florida, United States
Research Site — Tallahassee, Florida, United States
Research Site — West Palm Beach, Florida, United States
Research Site — Winter Haven, Florida, United States
Research Site — Atlanta, Georgia, United States
Research Site — Atlanta, Georgia, United States
Research Site — Columbus, Georgia, United States
Research Site — Honolulu, Hawaii, United States
Research Site — Chicago, Illinois, United States
Research Site — Chicago, Illinois, United States
Research Site — Decatur, Illinois, United States
Research Site — Elmhurst, Illinois, United States
Research Site — Hinsdale, Illinois, United States
Research Site — Park Ridge, Illinois, United States
Research Site — Park Ridge, Illinois, United States
Research Site — Fort Wayne, Indiana, United States
Research Site — Iowa City, Iowa, United States
Research Site — Fort Mitchell, Kentucky, United States
Research Site — Lexington, Kentucky, United States
Research Site — Louisville, Kentucky, United States
Research Site — Baton Rouge, Louisiana, United States
Research Site — Brewer, Maine, United States
Research Site — Scarborough, Maine, United States
Research Site — Frederick, Maryland, United States
Research Site — Glenn Dale, Maryland, United States
Research Site — Silver Spring, Maryland, United States
Research Site — Towson, Maryland, United States
Research Site — Boston, Massachusetts, United States
Research Site — Hyannis, Massachusetts, United States
Research Site — Ann Arbor, Michigan, United States
Research Site — Detroit, Michigan, United States
Research Site — East Lansing, Michigan, United States
Research Site — Lansing, Michigan, United States
Research Site — Royal Oak, Michigan, United States
Research Site — Independence, Missouri, United States
Research Site — Lincoln, Nebraska, United States
Research Site — Las Vegas, Nevada, United States
Research Site — Laconia, New Hampshire, United States
Research Site — Belleville, New Jersey, United States
Research Site — Farmington, New Mexico, United States
Research Site — Santa Fe, New Mexico, United States
Research Site — East Syracuse, New York, United States
Research Site — New Hyde Park, New York, United States
Research Site — New York, New York, United States
Research Site — New York, New York, United States
Research Site — New York, New York, United States
Research Site — Stony Brook, New York, United States
Research Site — The Bronx, New York, United States
Research Site — White Plains, New York, United States
Research Site — Charlotte, North Carolina, United States
Research Site — Durham, North Carolina, United States
Research Site — Greensboro, North Carolina, United States
Research Site — Raleigh, North Carolina, United States
Research Site — Rocky Mount, North Carolina, United States
Research Site — Winston-Salem, North Carolina, United States
Research Site — Winston-Salem, North Carolina, United States
Research Site — Cincinnati, Ohio, United States
Research Site — Cincinnati, Ohio, United States
Research Site — Cleveland, Ohio, United States
Research Site — Cleveland, Ohio, United States
Research Site — Youngstown, Ohio, United States
Research Site — Clairton, Pennsylvania, United States
Research Site — Philadelphia, Pennsylvania, United States
Research Site — Philadelphia, Pennsylvania, United States
Research Site — Pittsburgh, Pennsylvania, United States
Research Site — Reading, Pennsylvania, United States
Research Site — State College, Pennsylvania, United States
Research Site — Providence, Rhode Island, United States
Research Site — Lancaster, South Carolina, United States
Research Site — Spartanburg, South Carolina, United States
Research Site — Aberdeen, South Dakota, United States
Research Site — Mitchell, South Dakota, United States
Research Site — Pierre, South Dakota, United States
Research Site — Sioux Falls, South Dakota, United States
Research Site — Yankton, South Dakota, United States
Research Site — Chattanooga, Tennessee, United States
Research Site — Knoxville, Tennessee, United States
Research Site — Nashville, Tennessee, United States
Research Site — Nashville, Tennessee, United States
Research Site — Austin, Texas, United States
Research Site — Dallas, Texas, United States
Research Site — Denton, Texas, United States
Research Site — Houston, Texas, United States
Research Site — Houston, Texas, United States
Research Site — Irving, Texas, United States
Research Site — Ogden, Utah, United States
Research Site — Salt Lake City, Utah, United States
Research Site — Fairfax, Virginia, United States
Research Site — Lynchburg, Virginia, United States
Research Site — Midlothian, Virginia, United States
Research Site — Reston, Virginia, United States
Research Site — Richmond, Virginia, United States
Research Site — Seattle, Washington, United States
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Research Site — Spokane, Washington, United States
Research Site — Tacoma, Washington, United States
Research Site — Charleston, West Virginia, United States
Research Site — Morgantown, West Virginia, United States
Research Site — Appleton, Wisconsin, United States
Research Site — Madison, Wisconsin, United States
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Research Site — Buenos Aires, Argentina
Research Site — CABA, Argentina
Research Site — Capital Federal, Argentina
Research Site — Ciudad Autónoma Buenos Aires, Argentina
Research Site — Ciudad de Buenos Aires, Argentina
Research Site — Ciudad de Buenos Aires, Argentina
Research Site — Ciudad de Buenos Aires, Argentina
Research Site — Córdoba, Argentina
Research Site — Córdoba, Argentina
Research Site — La Plata, Argentina
Research Site — Mar del Plata, Argentina
Research Site — Salta, Argentina
Research Site — San Juan, Argentina
Research Site — San Miguel de Tucumán, Argentina
Research Site — San Miguel de Tucumán, Argentina
Research Site — Viedma, Argentina
Research Site — Birtinya, Australia
Research Site — Concord, Australia
Research Site — Nedlands, Australia
Research Site — Nedlands, Australia
Research Site — Randwick, Australia
Research Site — Tweed Heads, Australia
Research Site — Waratah, Australia
Research Site — Wendouree, Australia
Research Site — Graz, Austria
Research Site — Kufstein, Austria
Research Site — Ried, Austria
Research Site — Sankt Veit an der Glan, Austria
Research Site — Vienna, Austria
Research Site — Vienna, Austria
Research Site — Wein, Austria
Research Site — Wels, Austria
Research Site — Brussels, Belgium
Research Site — Edegem, Belgium
Research Site — Ghent, Belgium
Research Site — Leuven, Belgium
Research Site — Liège, Belgium
Research Site — Ottignies, Belgium
Research Site — Wilrijk, Belgium
Research Site — Yvoir, Belgium
Research Site — Alfenas, Brazil
Research Site — Belo Horizonte, Brazil
Research Site — Belo Horizonte, Brazil
Research Site — Brasília, Brazil
Research Site — Brasília, Brazil
Research Site — Chapecó, Brazil
Research Site — Cuiabá, Brazil
Research Site — Curitiba, Brazil
Research Site — Curitiba, Brazil
Research Site — Fortaleza, Brazil
Research Site — Fortaleza, Brazil
Research Site — Lajeado, Brazil
Research Site — Londrina, Brazil
Research Site — Natal, Brazil
Research Site — Niterói, Brazil
Research Site — Piracicaba, Brazil
Research Site — Porto Alegre, Brazil
Research Site — Porto Alegre, Brazil
Research Site — Porto Alegre, Brazil
Research Site — Porto Alegre, Brazil
Research Site — Pouso Alegre, Brazil
Research Site — Recife, Brazil
Research Site — Ribeirão Preto, Brazil
Research Site — Rio de Janeiro, Brazil
Research Site — Rio de Janeiro, Brazil
Research Site — Rio de Janeiro, Brazil
Research Site — Salvador, Brazil
Research Site — Salvador, Brazil
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Research Site — São Paulo, Brazil
Research Site — São Paulo, Brazil
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Research Site — Três Lagoas, Brazil
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Research Site — Dobrich, Bulgaria
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Research Site — Vratsa, Bulgaria
Research Site — Calgary, Alberta, Canada
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Research Site — Barrie, Ontario, Canada
Research Site — Ottawa, Ontario, Canada
Research Site — Sault Ste. Marie, Ontario, Canada
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Research Site — Windsor, Ontario, Canada
Research Site — Chicoutimi, Quebec, Canada
Research Site — Greenfield Park, Quebec, Canada
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Research Site — Montreal, Quebec, Canada
Research Site — Montreal, Quebec, Canada
Research Site — Saint-Jérôme, Quebec, Canada
Research Site — Concepción, Chile
Research Site — La Serena, Chile
Research Site — Port Montt, Chile
Research Site — Santiago, Chile
Research Site — Santiago, Chile
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Research Site — Talca, Chile
Research Site — Temuco, Chile
Research Site — Viña del Mar, Chile
Research Site — Baoding, China
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Research Site — Beijing, China
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Research Site — Beijing, China
Research Site — Changchun, China
Research Site — Changsha, China
Research Site — Chengdu, China
Research Site — Chengdu, China
Research Site — Chengdu, China
Research Site — Chifeng, China
Research Site — Dalian, China
Research Site — Foshan, China
Research Site — Fuzhou, China
Research Site — Fuzhou, China
Research Site — Guangzhou, China
Research Site — Guangzhou, China
Research Site — Guangzhou, China
Research Site — Haikou, China
Research Site — Haikou, China
Research Site — Hangzhou, China
Research Site — Hangzhou, China
Research Site — Hangzhou, China
Research Site — Hangzhou, China
Research Site — Harbin, China
Research Site — Hefei, China
Research Site — Hefei, China
Research Site — Hefei, China
Research Site — Hohhot, China
Research Site — Huangpu District, China
Research Site — Jinan, China
Research Site — Lanzhou, China
Research Site — Liuzhou, China
Research Site — Nanchang, China
Research Site — Nanjing, China
Research Site — Nanjing, China
Research Site — Nanning, China
Research Site — Nanning, China
Research Site — Neijiang, China
Research Site — Qingdao, China
Research Site — Shanghai, China
Research Site — Shanghai, China
Research Site — Shanghai, China
Research Site — Shantou, China
Research Site — Shaoguan, China
Research Site — Shenyang, China
Research Site — Shenyang, China
Research Site — Shijiazhuang, China
Research Site — Suining, China
Research Site — Suzhou, China
Research Site — Taiyuan, China
Research Site — Taizhou, China
Research Site — Tianjin, China
Research Site — Weifang, China
Research Site — Wuhan, China
Research Site — Wuhan, China
Research Site — Wuhan, China
Research Site — Xiangfan, China
Research Site — Xining, China
Research Site — Xinxiang, China
Research Site — Xuzhou, China
Research Site — Xuzhou, China
Research Site — Yanji, China
Research Site — Yantai, China
Research Site — Zhengzhou, China
Research Site — Barranquilla, Colombia
Research Site — Barranquilla, Colombia
Research Site — Bogotá, Colombia
Research Site — Bogotá, Colombia
Research Site — Cali, Colombia
Research Site — Floridablanca, Colombia
Research Site — Medellín, Colombia
Research Site — Montería, Colombia
Research Site — Pereira, Colombia
Research Site — Valledupar, Colombia
Research Site — Hořovice, Czechia
Research Site — Pardubice, Czechia
Research Site — Prague, Czechia
Research Site — Prague, Czechia
Research Site — Pragues, Czechia
Research Site — Příbram, Czechia
Research Site — Angers, France
Research Site — Argenteuil, France
Research Site — Avignon, France
Research Site — Bordeaux, France
Research Site — Bordeaux, France
Research Site — Bourg-en-Bresse, France
Research Site — Caen, France
Research Site — Cholet, France
Research Site — Clermont-Ferrand, France
Research Site — Dijon, France
Research Site — Epagny Metz-Tessy, France
Research Site — Lille, France
Research Site — Lorient, France
Research Site — Lyon, France
Research Site — Marseille, France
Research Site — Metz, France
Research Site — Montpellier, France
Research Site — Montpellier, France
Research Site — Nantes, France
Research Site — Nîmes, France
Research Site — Paris, France
Research Site — Paris, France
Research Site — Pierre-Bénite, France
Research Site — Plerin SUR MER, France
Research Site — Poitiers, France
Research Site — Quimper, France
Research Site — Rennes, France
Research Site — Saint-Cloud, France
Research Site — Saint-Herblain, France
Research Site — Saint-Priest-en-Jarez, France
Research Site — Suresnes, France
Research Site — Toulouse, France
Research Site — Tours, France
Research Site — Villejuif, France
Research Site — Batumi, Georgia
Research Site — Tbilisi, Georgia
Research Site — Tbilisi, Georgia
Research Site — Tbilisi, Georgia
Research Site — Tbilisi, Georgia
Research Site — Aachen, Germany
Research Site — Augsburg, Germany
Research Site — Bayreuth, Germany
Research Site — Berlin, Germany
Research Site — Berlin, Germany
Research Site — Bonn, Germany
Research Site — Deggendorf, Germany
Research Site — Dessau, Germany
Research Site — Dresden, Germany
Research Site — Düsseldorf, Germany
Research Site — Düsseldorf, Germany
Research Site — Eggenfelden, Germany
Research Site — Esslingen am Neckar, Germany
Research Site — Georgsmarienhütte, Germany
Research Site — Gütersloh, Germany
Research Site — Hamburg, Germany
Research Site — Hamburg, Germany
Research Site — Heidelberg, Germany
Research Site — Kiel, Germany
Research Site — Landshut, Germany
Research Site — Lübeck, Germany
Research Site — Mainz, Germany
Research Site — Memmingen, Germany
Research Site — München, Germany
Research Site — Ravensburg, Germany
Research Site — Rüsselsheim am Main, Germany
Research Site — Stralsund, Germany
Research Site — Torgau, Germany
Research Site — Trier, Germany
Research Site — Ulm, Germany
Research Site — Velbert, Germany
Research Site — Wiesbaden, Germany
Research Site — Wiesbaden, Germany
Research Site — Worms, Germany
Research Site — Wuppertal, Germany
Research Site — Athens, Greece
Research Site — Athens, Greece
Research Site — Athens, Greece
Research Site — Athens, Greece
Research Site — Chaïdári, Greece
Research Site — Heraklion, Greece
Research Site — Ioannina, Greece
Research Site — Rio, Greece
Research Site — Thessaloniki, Greece
Research Site — Thessaloniki, Greece
Research Site — Thessaloniki, Greece
Research Site — Thessaloniki, Greece
Research Site — Thessaloniki, Greece
Research Site — Budapest, Hungary
Research Site — Budapest, Hungary
Research Site — Budapest, Hungary
Research Site — Budapest, Hungary
Research Site — Debrecen, Hungary
Research Site — Győr, Hungary
Research Site — Gyula, Hungary
Research Site — Kaposvár, Hungary
Research Site — Miskolc, Hungary
Research Site — Nyíregyháza, Hungary
Research Site — Szekszárd, Hungary
Research Site — Szolnok, Hungary
Research Site — Bangalore, India
Research Site — Bangalore, India
Research Site — Belagavi, India
Research Site — Bhubaneswar, India
Research Site — Hubli, India
Research Site — Hyderabad, India
Research Site — Jaipur, India
Research Site — Kolkata, India
Research Site — Mumbai, India
Research Site — Nagpur, India
Research Site — Nashik, India
Research Site — New Delhi, India
Research Site — New Delhi, India
Research Site — New Delhi, India
Research Site — Pune, India
Research Site — Thane, India
Research Site — Visakhapatnam, India
Research Site — West Bengal, India
Research Site — Afula, Israel
Research Site — Ashdod, Israel
Research Site — Haifa, Israel
Research Site — Jerusalem, Israel
Research Site — Jerusalem, Israel
Research Site — Kfar Saba, Israel
Research Site — Nahariya, Israel
Research Site — Ramat Gan, Israel
Research Site — Rehovot, Israel
Research Site — Tel Aviv, Israel
Research Site — Bari, Italy
Research Site — Catania, Italy
Research Site — Catanzaro, Italy
Research Site — Florence, Italy
Research Site — Genova, Italy
Research Site — Grosseto, Italy
Research Site — Milan, Italy
Research Site — Milan, Italy
Research Site — Modena, Italy
Research Site — Naples, Italy
Research Site — Naples, Italy
Research Site — Pisa, Italy
Research Site — Reggio Emilia, Italy
Research Site — Roma, Italy
Research Site — Rozzano, Italy
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Research Site — Chiba, Japan
Research Site — Chūōku, Japan
Research Site — Fukuoka, Japan
Research Site — Fukushima, Japan
Research Site — Hidaka-shi, Japan
Research Site — Hirakata-shi, Japan
Research Site — Hiroshima, Japan
Research Site — Isehara-shi, Japan
Research Site — Kagoshima, Japan
Research Site — Kashiwa, Japan
Research Site — Kitaadachi-gun, Japan
Research Site — Kōtoku, Japan
Research Site — Kumamoto, Japan
Research Site — Kurume-shi, Japan
Research Site — Kyoto, Japan
Research Site — Matsuyama, Japan
Research Site — Nagoya, Japan
Research Site — Nagoya, Japan
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Research Site — Niigata, Japan
Research Site — Osaka, Japan
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Research Site — Osaka, Japan
Research Site — Ota-shi, Japan
Research Site — Ōita, Japan
Research Site — Sagamihara-shi, Japan
Research Site — Sapporo, Japan
Research Site — Sendai, Japan
Research Site — Shinagawa-ku, Japan
Research Site — Suita-shi, Japan
Research Site — Sunto-gun, Japan
Research Site — Takasaki-shi, Japan
Research Site — Tsu, Japan
Research Site — Yokohama, Japan
Research Site — George Town, Malaysia
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Research Site — Johor Bahru, Malaysia
Research Site — Kota Bharu, Malaysia
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Research Site — Kuching, Malaysia
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Research Site — Aguascalientes, Mexico
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Research Site — Monterrey, Mexico
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Research Site — Geleen, Netherlands
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Research Site — Arequipa, Peru
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Research Site — Callao, Peru
Research Site — La Libertad, Peru
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Research Site — Koszalin, Poland
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Research Site — Opole, Poland
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Research Site — Wieliszew, Poland
Research Site — Amadora, Portugal
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Research Site — Matosinhos Municipality, Portugal
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Research Site — Baia Mare, Romania
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Research Site — Manchester, United Kingdom
Research Site — Oxford, United Kingdom
Research Site — Peterborough, United Kingdom
Research Site — Stoke-on-Trent, United Kingdom
Research Site — Sutton, United Kingdom
Research Site — Hanoi, Vietnam
Research Site — Ho Chi Minh City, Vietnam
Research Site — Ho Chi Minh City, Vietnam
Research Site — Huế, Vietnam

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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