A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
Launched by ASTRAZENECA · Mar 7, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called camizestrant to see if it can help patients with early breast cancer that is hormone receptor-positive (ER+) and HER2-negative (HER2-). The trial is specifically looking at patients who have already completed at least 2 years of standard hormone therapy and have a higher risk of their cancer returning. Researchers want to find out if taking camizestrant for up to 5 years can improve their health outcomes compared to the usual hormone therapy.
To participate in this study, you need to be at least 18 years old and have had surgery for your breast cancer, along with other treatments like radiation or chemotherapy if required. You should have completed your initial hormone therapy and be classified as having a higher risk of recurrence based on specific medical criteria. Participants will receive camizestrant or standard hormone therapy for about 5 years, and the study is currently recruiting individuals of all genders. If you join, you can expect regular check-ups to monitor your health and response to the treatment throughout the trial.
Gender
ALL
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 reproductive hormone therapy or non-topical hormonal therapy for non-cancer-related conditions
- • 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
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Barcelona, , Spain
San Diego, California, United States
Cleveland, Ohio, United States
Ogden, Utah, United States
Fairfax, Virginia, United States
Nashville, Tennessee, United States
Orlando, Florida, United States
Fountain Valley, California, United States
Greenbrae, California, United States
Towson, Maryland, United States
Houston, Texas, United States
Plovdiv, , Bulgaria
Detroit, Michigan, United States
Brasschaat, , Belgium
Edegem, , Belgium
Gent, , Belgium
Barretos, , Brazil
Nyíregyháza, , Hungary
Hyderabad, , India
Pune, , India
Genova, , Italy
Białystok, , Poland
A Coruña, , Spain
Oviedo, , Spain
Salamanca, , Spain
Sevilla, , Spain
Aurora, Colorado, United States
Modena, , Italy
Guildford, , United Kingdom
Tacoma, Washington, United States
Madison, Wisconsin, United States
Cincinnati, Ohio, United States
Iloilo City, , Philippines
Dresden, , Germany
Chicago, Illinois, United States
Louisville, Kentucky, United States
Seattle, Washington, United States
Villejuif, , France
Kiel, , Germany
Milano, , Italy
Manchester, , United Kingdom
Park Ridge, Illinois, United States
Cleveland, Ohio, United States
Los Alamitos, California, United States
Las Vegas, Nevada, United States
Charlotte, North Carolina, United States
Brussel, , Belgium
Wilrijk, , Belgium
Yvoir, , Belgium
Calgary, Alberta, Canada
Winnipeg, Manitoba, Canada
Windsor, Ontario, Canada
Lille, , France
Paris, , France
Napoli, , Italy
Warszawa, , Poland
Liege, , Belgium
Budapest, , Hungary
Miskolc, , Hungary
Rio De Janeiro, , Brazil
Praha 4, , Czechia
Lérida, , Spain
Edinburgh, , United Kingdom
Iowa City, Iowa, United States
Valencia, , Spain
Miami Beach, Florida, United States
Raleigh, North Carolina, United States
Graz, , Austria
Innsbruck, , Austria
Klagenfurt, , Austria
Kufstein, , Austria
Linz, , Austria
St. Veit An Der Glan, , Austria
Steyr, , Austria
Vienna, , Austria
Voecklabruck, , Austria
Wels, , Austria
Wien, , Austria
Greenfield Park, Quebec, Canada
Toulouse, , France
Bari, , Italy
Ankara, , Turkey
Haifa, , Israel
East Lansing, Michigan, United States
Pittsburgh, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
London, , United Kingdom
Debrecen, , Hungary
Birmingham, Alabama, United States
Pereira, , Colombia
Anaheim, California, United States
Saint Petersburg, Florida, United States
Hinsdale, Illinois, United States
Lansing, Michigan, United States
Lincoln, Nebraska, United States
Bronx, New York, United States
New York, New York, United States
Greensboro, North Carolina, United States
Winston Salem, North Carolina, United States
Spartanburg, South Carolina, United States
Chattanooga, Tennessee, United States
Dallas, Texas, United States
Midlothian, Virginia, United States
Cordoba, , Argentina
Plovdiv, , Bulgaria
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Saint Herblain, , France
Heidelberg, , Germany
Mainz, , Germany
Szolnok, , Hungary
Sibiu, , Romania
Ann Arbor, Michigan, United States
San Diego, California, United States
Tallahassee, Florida, United States
Lisboa, , Portugal
Boston, Massachusetts, United States
Milwaukee, Wisconsin, United States
Aguascalientes, , Mexico
Lexington, Kentucky, United States
Ottignies, , Belgium
Morgantown, West Virginia, United States
Sutton, , United Kingdom
Bonn, , Germany
Düsseldorf, , Germany
Ioannina, , Greece
Firenze, , Italy
Rotterdam, , Netherlands
Brighton, , United Kingdom
Stoke On Trent, , United Kingdom
Randwick, , Australia
Cambridge, , United Kingdom
Philadelphia, Pennsylvania, United States
Lyon, , France
Gyula, , Hungary
Madrid, , Spain
Roma, , Italy
Ried, , Austria
Plantation, Florida, United States
Richmond, Virginia, United States
Chandler, Arizona, United States
Beverly Hills, California, United States
Concord, California, United States
Ottawa, Ontario, Canada
Dijon, , France
Peterborough, , United Kingdom
Ramat Gan, , Israel
Providence, Rhode Island, United States
Spokane, Washington, United States
Villejuif Cedex, , France
La Plata, , Argentina
Concord, , Australia
New Delhi, , India
Manila, , Philippines
Singapore, , Singapore
Johannesburg, , South Africa
Bangkok, , Thailand
West Palm Beach, Florida, United States
Wein, , Austria
Nantes, , France
Nahariya, , Israel
Iasi, , Romania
Madrid, , Spain
Stony Brook, New York, United States
Seattle, Washington, United States
Caen Cedex 05, , France
Port Saint Lucie, Florida, United States
Bayreuth, , Germany
Geleen, , Netherlands
Kragujevac, , Serbia
Nis, , Serbia
Sevilla, , Spain
Lublin, , Poland
Fort Myers, Florida, United States
Anchorage, Alaska, United States
Santa Fe, New Mexico, United States
Aberdeen, South Dakota, United States
Sioux Falls, South Dakota, United States
Knoxville, Tennessee, United States
Irving, Texas, United States
Lynchburg, Virginia, United States
Saint Jerome, Quebec, Canada
Beijing, , China
Shanghai, , China
Horovice, , Czechia
Pribram, , Czechia
Grosseto, , Italy
Cluj Napoca, , Romania
Sremska Kamenica, , Serbia
Bloemfontein, , South Africa
Taichung, , Taiwan
Tainan, , Taiwan
Rozzano, , Italy
Mexico, , Mexico
Barcelona, , Spain
Aachen, , Germany
Pisa, , Italy
Honolulu, Hawaii, United States
Athens, , Greece
Koszalin, , Poland
Heraklion, , Greece
Majadahonda, , Spain
Fort Wayne, Indiana, United States
Charleston, West Virginia, United States
Tianjin, , China
Oxford, , United Kingdom
Trujillo, , Peru
Winter Haven, Florida, United States
Elmhurst, Illinois, United States
Baton Rouge, Louisiana, United States
Scarborough, Maine, United States
Frederick, Maryland, United States
East Syracuse, New York, United States
Youngstown, Ohio, United States
Jaipur, , India
Chuo Ku, , Japan
Fukuoka Shi, , Japan
Kagoshima Shi, , Japan
Nagoya Shi, , Japan
Niigata Shi, , Japan
Iloilo City, , Philippines
Taipei, , Taiwan
Songkla, , Thailand
Kelowna, British Columbia, Canada
Barrie, Ontario, Canada
Trier, , Germany
Tel Aviv, , Israel
Toluca, , Mexico
Hoofddorp, , Netherlands
Pietermaritzburg, , South Africa
Milan, , Italy
Matsuyama Shi, , Japan
Caba, , Argentina
Beijing, , China
Nanning, , China
Kaposvár, , Hungary
Szekszárd, , Hungary
Kuching, , Malaysia
Cebu, , Philippines
Grudziadz, , Poland
Salt Lake City, Utah, United States
Toulouse Cedex 09, , France
Catania, , Italy
Koto Ku, , Japan
Belgrade, , Serbia
Sunto Gun, , Japan
Poitiers, , France
Saint Cloud, , France
George, , South Africa
Columbus, Georgia, United States
Braga, , Portugal
Chicoutimi, Quebec, Canada
Bourg En Bresse, , France
Clermont Ferrand, , France
Augsburg, , Germany
Berlin, , Germany
Baia Mare, , Romania
Leuven, , Belgium
Mons, , Belgium
Marseille, , France
Valencia, , Spain
Decatur, Illinois, United States
Ravensburg, , Germany
Ulm, , Germany
Palo Alto, California, United States
Changchun, , China
Hangzhou, , China
Taiyuan, , China
Wuhan, , China
Sendai Shi, , Japan
Nimes, , France
Guangzhou, , China
Kumamoto Shi, , Japan
Suita Shi, , Japan
Monterrey, , Mexico
Derby, , United Kingdom
Sofia, , Bulgaria
Chiba Shi, , Japan
Osaka Shi, , Japan
Seoul, , Korea, Republic Of
Whittier, California, United States
Royal Oak, Michigan, United States
Opole, , Poland
New Hyde Park, New York, United States
Rocky Mount, North Carolina, United States
Mar Del Plata, , Argentina
Veracruz, , Mexico
Groningen, , Netherlands
Bacolod, , Philippines
Phisanulok, , Thailand
Hanoi, , Vietnam
Ho Chi Minh City, , Vietnam
Atlanta, Georgia, United States
Belleville, New Jersey, United States
Changsha, , China
Tsu Shi, , Japan
Brasov, , Romania
Albacete, , Spain
Bursa, , Turkey
Ho Chi Minh, , Vietnam
Sao Paulo, , Brazil
Esslingen, , Germany
Hyannis, Massachusetts, United States
Metz Cedex 03, , France
Athens, , Greece
Amadora, , Portugal
Porto, , Portugal
Santander, , Spain
Tbilisi, , Georgia
Nedlands, , Australia
Saint Herblain Cedex, , France
Villejuif, , France
Hirakata Shi, , Japan
Kashiwa, , Japan
Waratah, , Australia
Jeonnam, , Korea, Republic Of
Fuzhou, , China
Nanjing, , China
Shenyang, , China
Saint Augustine, Florida, United States
Harbin, , China
Kitaadachi Gun, , Japan
Yokohama Shi, , Japan
Pardubice, , Czechia
Guimarães, , Portugal
Atlanta, Georgia, United States
New York, New York, United States
Győr, , Hungary
Vila Nova De Gaia, , Portugal
Silver Spring, Maryland, United States
Brewer, Maine, United States
Kyoto Shi, , Japan
Winston Salem, North Carolina, United States
Clairton, Pennsylvania, United States
Gerona, , Spain
L'hospitalet De Llobregat, , Spain
Vitória, , Brazil
Floridablanca, , Colombia
Isehara Shi, , Japan
Daegu, , Korea, Republic Of
Cáceres, , Spain
San Juan De Alicante, , Spain
Hsinchu, , Taiwan
Shinagawa Ku, , Japan
Granada, , Spain
Chicago, Illinois, United States
White Plains, New York, United States
San Miguel De Tucuman, , Argentina
Tweed Heads, , Australia
Wendouree, , Australia
Shijiazhuang, , China
Avignon, , France
Bordeaux Cedex, , France
Plerin Sur Mer, , France
Rennes, , France
Deggendorf, , Germany
Eggenfelden, , Germany
Memmingen, , Germany
Hidaka Shi, , Japan
Ota Shi, , Japan
Goyang Si, , Korea, Republic Of
Elche(alicante), , Spain
Reus,Tarragona, , Spain
San Sebastián, , Spain
Tainan City, , Taiwan
San Juan, , Argentina
Catanzaro, , Italy
Matosinhos, , Portugal
Murcia, , Spain
Rehovot, , Israel
Fort Mitchell, Kentucky, United States
Vratsa, , Bulgaria
Quezon City, , Philippines
Haikou, , China
Hohhot, , China
Yanji, , China
Pretoria, , South Africa
Sagamihara Shi, , Japan
Singapore, , Singapore
Taipei City, , Taiwan
Amanzimtoti, , South Africa
Kaohsiung, , Taiwan
Khon Kaen, , Thailand
Racibórz, , Poland
Hue, , Vietnam
Velbert, , Germany
Dobrich, , Bulgaria
Fukushima Shi, , Japan
Barranquilla, , Colombia
Mexico City, , Mexico
Lorient Cedex, , France
Sabah, , Malaysia
Barakaldo, , Spain
Hartford, Connecticut, United States
Gainesville, Florida, United States
Suzhou, , China
Kfar Saba, , Israel
Batumi, , Georgia
Hefei, , China
Belgrad, , Serbia
Phitsanulok, , Thailand
Sapporo, , Japan
Nanchang, , China
Bogota, , Colombia
Sault Ste. Marie, Ontario, Canada
Dothan, Alabama, United States
Lancaster, South Carolina, United States
Wiesbaden, , Germany
Valjevo, , Serbia
Alzira, , Spain
Ji Nan, , China
Yantai, , China
Wieliszew, , Poland
łódź, , Poland
Suresnes Cedex, , France
Badalona, , Spain
Bangalore, , India
Temuco, , Chile
Pierre Benite, , France
Kaohsiung, , Taiwan
Buenos Aires, , Argentina
Dalian, , China
Qingdao, , China
Xuzhou, , China
Argenteuil, , France
Belo Horizonte, , Brazil
Lima, , Peru
Chifeng, , China
Belagavi, , India
Kolkata, , India
Takasaki Shi, , Japan
Foshan, , China
Floresti, , Romania
Tours Cedex, , France
Guetersloh, , Germany
Corona, California, United States
Farmington, New Mexico, United States
Xining, , China
Zhengzhou, , China
Hiroshima Shi, , Japan
Neijiang, , China
San Miguel De Tucumán, , Argentina
Aydin, , Turkey
Johor Bahru, , Malaysia
Chengdu, , China
Montpellier, , France
München, , Germany
Nashik, , India
New Delhi, , India
Busan, , Korea, Republic Of
La Libertad, , Peru
Suresnes, , France
Dessau Rosslau, , Germany
Ciudad De Buenos Aires, , Argentina
Curitiba, , Brazil
San Luis Potosí, , Mexico
Quimper Cedex, , France
Londrina, , Brazil
Worms, , Germany
Constanta, , Romania
Rzeszów, , Poland
Mumbai, , India
Alc. Cuauhtémoc, , Mexico
Georgsmarienhuette, , Germany
Viedma, , Argentina
Natal, , Brazil
Thane, , India
Nagpur, , India
Montpellier Cedex 5, , France
Baoding, , China
Afula, , Israel
Puerto De Sagunto, , Spain
Monteria, , Colombia
Valledupar, , Colombia
Johannesburg, , South Africa
Taizhou, , China
Burton On Trent, , United Kingdom
Cholet, , France
Cali, , Colombia
Medellin, , Colombia
Chaidari, , Greece
Birtinya, , Australia
Shantou, , China
Ribeirão Preto, , Brazil
Salvador, , Brazil
La Serena, , Chile
Istanbul, , Turkey
West Bengal, , India
Ashdod, , Israel
Tres Lagoas, , Brazil
Hot Springs National Park, Arkansas, United States
Oita Shi, , Japan
Alzira, , Spain
Modena, , Italy
Galdakao, , Spain
Brasilia, , Brazil
Kurume Shi, , Japan
Soweto, , South Africa
Beijing, , China
Denton, Texas, United States
Capital Federal, , Argentina
Stralsund, , Germany
Wuppertal, , Germany
Porto Alegre, , Brazil
Cluj Napoca, , Romania
Craiova, , Romania
Brasilia, , Brazil
Puerto Montt, , Chile
Shaoguan, , China
Niterói, , Brazil
Badajoz, , Spain
Vina Del Mar, , Chile
Xinxiang, , China
Ipswich, , United Kingdom
Turin, , Italy
Timisoara, , Romania
Xiangfan, , China
Rio, , Greece
Thessaloniki, , Greece
Taubaté, , Brazil
Concepcion, , Chile
Huangpu District, , China
Toledo, , Spain
Epagny Metz Tessy, , France
Luebeck, , Germany
Lajeado, , Brazil
Ciudad Autonoma De Buenos Aires, , Argentina
Ciudad Autónoma Buenos Aires, , Argentina
Salta, , Argentina
Brighton, , Australia
Brasília, , Brazil
Chapeco, , Brazil
Fortaleza, , Brazil
Piracicaba, , Brazil
São Paulo, , Brazil
Dinar, , Turkey
Istambul, , Turkey
İzmir, , Turkey
Izmir, , Turkey
Samsun, , Turkey
Georgetown, , Malaysia
Glenn Dale, Maryland, United States
Laconia, New Hampshire, United States
Durham, North Carolina, United States
Reading, Pennsylvania, United States
State College, Pennsylvania, United States
Reston, Virginia, United States
Pouso Alegre, , Brazil
Santiago, , Chile
Guangzhou Shi, , China
Lanzhou, , China
Liuzhou, , China
Suining, , China
Weifang, , China
Wuhan, , China
Pragues, , Czechia
Angers Cedex 01, , France
Bordeaux Cédex, , France
Hamburg, , Germany
Landshut, , Germany
Torgau, , Germany
Thessaloniki, , Greece
Hubli, , India
Jerusalem, , Israel
Reggio Emilia, , Italy
Donggu, , Korea, Republic Of
Seongbuk Gu, , Korea, Republic Of
George Town, , Malaysia
Kota Bharu, , Malaysia
Kuala Lumpur, , Malaysia
Melaka, , Malaysia
Mérida, , Mexico
Dirksland, , Netherlands
Arequipa, , Peru
Callao, , Peru
Oradea, , Romania
Beograd, , Serbia
Zrenjanin, , Serbia
Alcoy, , Spain
Alicant, , Spain
Jerez De La Frontera (Cádiz), , Spain
Leganés, , Spain
Manresa, , Spain
Parla, , Spain
Teruel, , Spain
Rachathewi, , Thailand
Keighley, , United Kingdom
Alfenas, , Brazil
Cuiabá, , Brazil
Recife, , Brazil
Bhubaneswar, , India
Visakhapatnam, , India
Colonia Lindavista, , Mexico
Poznań, , Poland
Pitesti, , Romania
Independence, Missouri, United States
Talca, , Chile
Praha, , Czechia
Cali, , Colombia
Rüsselsheim Am Main, , Germany
Appleton, Wisconsin, United States
St Priest En Jarez, , France
Shantou, , China
Granada, , Spain
Mitchell, South Dakota, United States
Pierre, South Dakota, United States
Yankton, South Dakota, United States
Osaka Shi, , Japan
Hohhot, , China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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