An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
Launched by ASTRAZENECA · Jul 11, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
The CAMBRIA-2 trial is researching a new treatment called camizestrant for people with early-stage breast cancer that is hormone receptor-positive (ER+) and does not have a certain protein called HER2 (HER2-). This study aims to find out if camizestrant can help patients do better than the standard treatment they usually receive after surgery. The trial is open to both men and women aged 18 and older who have already had surgery to remove their breast cancer and are at risk of the cancer coming back. Participants will be treated for a total of 7 years.
To join the study, patients must have had their breast cancer fully removed and not have any spread to other parts of the body. They should not have severe heart issues or other uncontrolled health problems. Participants will be closely monitored during the trial and will receive either camizestrant or standard treatment, with regular check-ups to track their health and response to the therapy. If you or a loved one is interested in this study, it could be a valuable opportunity to contribute to breast cancer research while receiving care.
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 absence of any evidence of metastatic disease 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.
- • Patients must be randomised within 12 months of definitive breast surgery.
- • Patients may have received up to 12 weeks of endocrine therapy prior to randomisation.
- • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- • Adequate organ and bone 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 a 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
Rochester, Minnesota, United States
Durham, North Carolina, United States
Houston, Texas, United States
Charlottesville, Virginia, United States
Cleveland, Ohio, United States
Fairfax, Virginia, United States
Nashville, Tennessee, United States
Orlando, Florida, United States
Minneapolis, Minnesota, United States
Fountain Valley, California, United States
Greenbrae, California, United States
Pembroke Pines, Florida, United States
Towson, Maryland, United States
Memphis, Tennessee, United States
Norfolk, Virginia, United States
Milwaukee, Wisconsin, United States
Shumen, , Bulgaria
Varna, , Bulgaria
Urbana, Illinois, United States
Detroit, Michigan, United States
Brasschaat, , Belgium
Edegem, , Belgium
Gent, , Belgium
Nyíregyháza, , Hungary
Ansari Nagar, , India
Hyderabad, , India
Mumbai, , India
Białystok, , Poland
Malaga, , Spain
Salamanca, , Spain
Aurora, Colorado, United States
Portland, Oregon, United States
Madison, Wisconsin, United States
Walnut Creek, California, United States
El Paso, Texas, United States
Bethesda, Maryland, United States
Fayetteville, Arkansas, United States
Chicago, Illinois, United States
Louisville, Kentucky, United States
Columbus, Ohio, United States
Salt Lake City, Utah, United States
Milano, , Italy
Zaragoza, , Spain
London, , United Kingdom
Manchester, , United Kingdom
Gainesville, Florida, United States
Park Ridge, Illinois, United States
Charlotte, North Carolina, United States
Leuven, , Belgium
Namur, , Belgium
Wilrijk, , Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Windsor, Ontario, Canada
Lille, , France
Jerusalem, , Israel
Napoli, , Italy
Padova, , Italy
Warszawa, , Poland
Madrid, , Spain
New Orleans, Louisiana, United States
Miskolc, , Hungary
Porto, , Portugal
Goiânia, , Brazil
Saint Cloud, , France
Barcelona, , Spain
Lérida, , Spain
Philadelphia, Pennsylvania, United States
Torino, , Italy
Valencia, , Spain
Raleigh, North Carolina, United States
Oklahoma City, Oklahoma, United States
Graz, , Austria
Innsbruck, , Austria
Klagenfurt, , Austria
Linz, , Austria
Salzburg, , Austria
St. Veit An Der Glan, , Austria
Steyr, , Austria
Vienna, , Austria
Wels, , Austria
Wiener Neustadt, , Austria
Wien, , Austria
Heidelberg, , Australia
Charleroi, , Belgium
Kingston, Ontario, Canada
Bordeaux, , France
Toulouse, , France
Auckland, , New Zealand
Basel, , Switzerland
San Antonio, Texas, United States
Haifa, , Israel
New Haven, Connecticut, United States
Baltimore, Maryland, United States
Worcester, Massachusetts, United States
Pittsburgh, Pennsylvania, United States
Montreal, Quebec, Canada
Quebec, , Canada
Debrecen, , Hungary
Bydgoszcz, , Poland
Levis, Quebec, Canada
Los Angeles, California, United States
Littleton, Colorado, United States
Saint Petersburg, Florida, United States
Annapolis, Maryland, United States
Kansas City, Missouri, United States
Saint Louis, Missouri, United States
Lincoln, Nebraska, United States
Lebanon, New Hampshire, United States
New York, New York, United States
Greensboro, North Carolina, United States
Winston Salem, North Carolina, United States
Hershey, Pennsylvania, United States
Sayre, Pennsylvania, United States
Spartanburg, South Carolina, United States
Chattanooga, Tennessee, United States
Dallas, Texas, United States
Midlothian, Virginia, United States
Roanoke, Virginia, United States
Aalst, , Belgium
Haskovo, , Bulgaria
Plovdiv, , Bulgaria
Saint Herblain, , France
Heidelberg, , Germany
Mainz, , Germany
Zalaegerszeg, , Hungary
Beer Sheva, , Israel
Trento, , Italy
Gdynia, , Poland
Sibiu, , Romania
Leeds, , United Kingdom
Greenville, South Carolina, United States
Tallahassee, Florida, United States
Novara, , Italy
Lisboa, , Portugal
Boston, Massachusetts, United States
Milwaukee, Wisconsin, United States
New Brunswick, New Jersey, United States
Richmond, Virginia, United States
New York, New York, United States
Duarte, California, United States
Newark, Delaware, United States
Marietta, Georgia, United States
Charleston, South Carolina, United States
Praha 5, , Czechia
Morgantown, West Virginia, United States
Sutton, , United Kingdom
Omaha, Nebraska, United States
Firenze, , Italy
Badalona, , Spain
Girona, , Spain
San Sebastian, , Spain
West Hollywood, California, United States
Randwick, , Australia
Gyula, , Hungary
Wroclaw, , Poland
Leicester, , United Kingdom
Toledo, Ohio, United States
Austin, Texas, United States
Jacksonville, Florida, United States
Pinehurst, North Carolina, United States
Knoxville, Tennessee, United States
Tyler, Texas, United States
Vancouver, Washington, United States
Hannover, , Germany
Chur, , Switzerland
La Jolla, California, United States
Greenville, North Carolina, United States
Spokane, Washington, United States
Villejuif Cedex, , France
La Plata, , Argentina
Tallinn, , Estonia
New Delhi, , India
Manila, , Philippines
Johannesburg, , South Africa
Taichung, , Taiwan
Kecskemét, , Hungary
Gdańsk, , Poland
Rijeka, , Croatia
Zagreb, , Croatia
West Palm Beach, Florida, United States
South Brisbane, , Australia
Brno, , Czechia
Nahariya, , Israel
Iasi, , Romania
Stony Brook, New York, United States
Oxford, , United Kingdom
Barcelona, , Spain
Clearwater, Florida, United States
Caen Cedex 05, , France
Jacksonville, Florida, United States
Fitzroy, , Australia
Hamilton, , New Zealand
Belgrade, , Serbia
Kragujevac, , Serbia
Nis, , Serbia
Novi Sad, , Serbia
Cape Town, , South Africa
Sevilla, , Spain
Bay Shore, New York, United States
Fort Myers, Florida, United States
Thomasville, Georgia, United States
Gettysburg, Pennsylvania, United States
Aberdeen, South Dakota, United States
Sioux Falls, South Dakota, United States
Bedford, Texas, United States
Rio De Janeiro, , Brazil
Beijing, , China
Cebu City, , Philippines
Rzeszow, , Poland
Cluj Napoca, , Romania
Timisoara, , Romania
Bloemfontein, , South Africa
Tainan, , Taiwan
Santo André, , Brazil
Rozzano, , Italy
Mexico, , Mexico
Rock Hill, South Carolina, United States
Bologna, , Italy
Bruxelles, , Belgium
Osijek, , Croatia
Aachen, , Germany
Szeged, , Hungary
Nashik, , India
Sudbury, Ontario, Canada
Dublin, , Ireland
Koszalin, , Poland
Cambridge, , United Kingdom
Shrewsbury, , United Kingdom
Halifax, Nova Scotia, Canada
Heraklion, , Greece
Budapest, , Hungary
Pierre Benite, , France
Fort Wayne, Indiana, United States
Charleston, West Virginia, United States
Modena, , Italy
Tianjin, , China
Szczecin, , Poland
Port Elizabeth, , South Africa
Seoul, , Korea, Republic Of
Elmhurst, Illinois, United States
Des Moines, Iowa, United States
Scarborough, Maine, United States
East Syracuse, New York, United States
Youngstown, Ohio, United States
Sioux Falls, South Dakota, United States
Winchester, Virginia, United States
Chuo Ku, , Japan
Fukuoka Shi, , Japan
Hiroshima Shi, , Japan
Kagoshima Shi, , Japan
Nagoya Shi, , Japan
Niigata Shi, , Japan
Sapporo Shi, , Japan
Iloilo City, , Philippines
Plano, Texas, United States
Kelowna, British Columbia, Canada
Barrie, Ontario, Canada
Koblenz, , Germany
Quebec, , Canada
Lausanne, , Switzerland
Luzern, , Switzerland
Milan, , Italy
Matsuyama Shi, , Japan
San Isidro, , Peru
Dijon, , France
Roma, , Italy
Clayton, , Australia
Garran, , Australia
Nanjing, , China
Nanning, , China
Suzhou, , China
Kaposvár, , Hungary
Szekszárd, , Hungary
Jerusalem, , Israel
Kfar Saba, , Israel
Grudziadz, , Poland
Lublin, , Poland
Granada, , Spain
Northampton, , United Kingdom
Toulouse Cedex 09, , France
Bellinzona, , Switzerland
Kashiwa, , Japan
Koto Ku, , Japan
Belgrade, , Serbia
Winterthur, , Switzerland
Sunto Gun, , Japan
George, , South Africa
Tbilisi, , Georgia
Columbus, Georgia, United States
Braga, , Portugal
Ypsilanti, Michigan, United States
Split, , Croatia
El Palmar, , Spain
Chicoutimi, Quebec, Canada
Oradea, , Romania
Montpellier, , France
Witten, , Germany
Marseille, , France
Valencia, , Spain
Savannah, Georgia, United States
Sendai Shi, , Japan
Changchun, , China
Chengdu, , China
Dalian, , China
Shenyang, , China
Shijiazhuang, , China
Washington, District Of Columbia, United States
Nimes, , France
Thunder Bay, Ontario, Canada
Guangzhou, , China
Kumamoto Shi, , Japan
Suita Shi, , Japan
Derby, , United Kingdom
Sofia, , Bulgaria
Chiba Shi, , Japan
Seongnam Si, , Korea, Republic Of
Monterrey, , Mexico
Warwick, , United Kingdom
Portland, Oregon, United States
Rio Piedras, , Puerto Rico
Freudenstadt, , Germany
Vila Real, , Portugal
Phoenix, Arizona, United States
Bergamo, , Italy
Genoa, , Italy
Monza, , Italy
Clermont Ferrand, , France
Opole, , Poland
New Hyde Park, New York, United States
Melbourne, , Australia
Wollongong, , Australia
Porto Alegre, , Brazil
Hefei, , China
Berlin, , Germany
Afula, , Israel
Seoul, , Korea, Republic Of
Bacolod, , Philippines
Flint, Michigan, United States
York, Pennsylvania, United States
Changsha, , China
Tsu Shi, , Japan
Albacete, , Spain
Alicante, , Spain
Sabadell, , Spain
Bursa, , Turkey
Malatya, , Turkey
Aberdeen, , United Kingdom
Naperville, Illinois, United States
Hyannis, Massachusetts, United States
Amadora, , Portugal
Porto, , Portugal
Saarbrücken, , Germany
Hirakata Shi, , Japan
Waratah, , Australia
Meldola, , Italy
Cincinnati, Ohio, United States
Nanjing, , China
Shenzhen, , China
Albuquerque, New Mexico, United States
Bengbu, , China
Fuzhou, , China
Harbin, , China
Wuhan, , China
Yokohama Shi, , Japan
Pardubice, , Czechia
Atlanta, Georgia, United States
Buenos Aires, , Argentina
Saskatoon, Saskatchewan, Canada
Győr, , Hungary
Vila Nova De Gaia, , Portugal
Osaka Shi, , Japan
Kyoto Shi, , Japan
Tucson, Arizona, United States
Plantation, Florida, United States
Coffs Harbour, , Australia
Cangzhou, , China
Isehara Shi, , Japan
Daegu, , Korea, Republic Of
La Laguna (Tenerife), , Spain
Hsinchu, , Taiwan
Hat Yai, , Thailand
Antalya, , Turkey
Saint Louis, Missouri, United States
Shinagawa Ku, , Japan
Daegu, , Korea, Republic Of
Bucuresti, , Romania
Taipei, , Taiwan
Edirne, , Turkey
Fairway, Kansas, United States
White Plains, New York, United States
San Miguel De Tucuman, , Argentina
Anderlecht, , Belgium
Plerin Sur Mer, , France
Deggendorf, , Germany
Düsseldorf, , Germany
Karlsruhe, , Germany
Schweinfurt, , Germany
Ota Shi, , Japan
Goyang Si, , Korea, Republic Of
Lisboa, , Portugal
Elche(alicante), , Spain
Reus,Tarragona, , Spain
San Juan, , Argentina
Matosinhos, , Portugal
Murcia, , Spain
Vratsa, , Bulgaria
Blue Ash, Ohio, United States
Hohhot, , China
Tartu, , Estonia
Frankston, , Australia
Bendigo, , Australia
Bunkyo Ku, , Japan
Amanzimtoti, , South Africa
Haikou, , China
Lutherville, Maryland, United States
Khon Kaen, , Thailand
Racibórz, , Poland
Taichung, , Taiwan
Rennes, , France
Trujillo, , Peru
St Leonards, , Australia
Dobrich, , Bulgaria
Fukushima Shi, , Japan
Nagoya Shi, , Japan
Barranquilla, , Colombia
Rouen, , France
Barakaldo, , Spain
Riyadh, , Saudi Arabia
Ribeirão Preto, , Brazil
Rostock, , Germany
Stockton, , United Kingdom
Vandoeuvre Les Nancy, , France
Suzhou, , China
Ioannina, , Greece
Liverpool, , Australia
Hefei, , China
Belgrad, , Serbia
Curitiba, , Brazil
Nanchang, , China
Sao Paulo, , Brazil
Belo Horizonte, , Brazil
Bogota, , Colombia
Lima, , Peru
Sault Ste. Marie, Ontario, Canada
Irvine, California, United States
St. Gallen, , Switzerland
Dothan, Alabama, United States
Nantes, , France
Darmstadt, , Germany
Wiesbaden, , Germany
Valjevo, , Serbia
Speyer, , Germany
Salvador, , Brazil
Shijiahzhuang, , China
Wuhan, , China
Taipei, , Taiwan
Burgos, , Spain
Taunton, , United Kingdom
Lancaster, , United Kingdom
Ramat Gan, , Israel
łódź, , Poland
Cordoba, , Spain
Athens, , Greece
Gurgaon, , India
Arequipa, , Peru
La Coruña, , Spain
Quezon, , Philippines
Viana Do Castelo, , Portugal
Jerez De La Frontera, , Spain
Batumi, , Georgia
Caceres, , Spain
Brindisi, , Italy
Fuenlabrada, , Spain
Subiaco, , Australia
Salvador, , Brazil
Belo Horizonte, , Brazil
Karsiyaka, , Turkey
Shenyang, , China
Chifeng, , China
Kolkata, , India
Takasaki Shi, , Japan
Foshan, , China
Floresti, , Romania
Flower Mound, Texas, United States
Porto Alegre, , Brazil
Farmington, New Mexico, United States
Linyi, , China
Tomaszów Mazowiecki, , Poland
Bangkok, , Thailand
Neijiang, , China
Zunyi, , China
Granada, , Spain
Nashik, , India
Kuala Lumpur, , Malaysia
Sutton In Ashfield, , United Kingdom
Johor Bahru, , Malaysia
Pulau Pinang, , Malaysia
Essen, , Germany
Vigo, , Spain
Hamburg, , Germany
Cork, , Ireland
Palma De Mallorca, , Spain
Nantong, , China
Frauenfeld, , Switzerland
La Libertad, , Peru
Liberec, , Czechia
Dessau Rosslau, , Germany
Surat, , India
Dresden, , Germany
Curitiba, , Brazil
Mysuru, , India
Temuco, , Chile
İstanbul, , Turkey
Worms, , Germany
Rzeszów, , Poland
Bangalore, , India
Alc. Cuauhtémoc, , Mexico
Monterey, California, United States
Bankstown, , Australia
Bowral, , Australia
Traralgon, , Australia
Georgsmarienhuette, , Germany
Viedma, , Argentina
Natal, , Brazil
Teresina, , Brazil
Cleveland, Ohio, United States
Capital Federal, , Argentina
Baoding, , China
Huizhou, , China
Horovice, , Czechia
Monteria, , Colombia
Valledupar, , Colombia
Nagpur, , India
Cheonan Si, , Korea, Republic Of
Cordoba, , Argentina
Liverpool, , United Kingdom
Taizhou, , China
Paris, , France
A Coruña, , Spain
Burton On Trent, , United Kingdom
Castello De La Plana, , Spain
Cali, , Colombia
Marousi, , Greece
Puyallup, Washington, United States
Kolkata, , India
La Serena, , Chile
Providencia, , Chile
Ankara, , Turkey
Istanbul, , Turkey
Blumenau, , Brazil
Ashdod, , Israel
Fortaleza, , Brazil
Tres Lagoas, , Brazil
Strasbourg, , France
Kanpur, , India
Biała Podlaska, , Poland
Whitchurch, , United Kingdom
Bath, , United Kingdom
Ribeirão Preto, , Brazil
Murdoch, , Australia
Iruma Gun, , Japan
Galway, , Ireland
Brasília, , Brazil
Kurume Shi, , Japan
Tbilisi, , Georgia
Offenburg, , Germany
Wuppertal, , Germany
Cancún, , Mexico
Cluj Napoca, , Romania
Craiova, , Romania
Rosario, , Argentina
North Vancouver, British Columbia, Canada
Jaipur, , India
Rio De Janeiro, , Brazil
Puerto Montt, , Chile
çankaya, , Turkey
Vina Del Mar, , Chile
Hangzhou, , China
Xinxiang, , China
Ipswich, , United Kingdom
Veracruz, , Mexico
Timisoara, , Romania
Vitória, , Brazil
Xiangfan, , China
Rio, , Greece
Thessaloniki, , Greece
Taubaté, , Brazil
Concepcion, , Chile
Zürich, , Switzerland
Nurtingen, , Germany
San Luis Potosí, , Mexico
Toledo, , Spain
Santiago, , Chile
Misterbianco, , Italy
Sevilla, , Spain
Epagny Metz Tessy, , France
Brighton, , Australia
Porto Alegre, , Brazil
Samsun, , Turkey
Kraków, , Poland
Porto Velho, , Brazil
Ovidiu, , Romania
Pouso Alegre, , Brazil
Guangzhou Shi, , China
Lanzhou, , China
Liuzhou, , China
Weifang, , China
Tbilisi, , Georgia
Torgau, , Germany
Kota Bharu, , Malaysia
Melaka, , Malaysia
Mérida, , Mexico
Beograd, , Serbia
Zrenjanin, , Serbia
Pretoria, , South Africa
Alfenas, , Brazil
Colonia Lindavista, , Mexico
Poznań, , Poland
Pitesti, , Romania
Hanau, , Germany
Kuching, , Malaysia
Cali, , Colombia
São Paulo, , Brazil
Caba, , Argentina
Zadar, , Croatia
Itajai, , Brazil
Joao Pessoa, , Brazil
Delhi, , India
Angers, , France
Ciudad De Córdoba, , Argentina
Pietermaritzburg, , South Africa
Reading, , United Kingdom
Dublin, , Ireland
Palmerston North, , New Zealand
São Paulo, , Brazil
Dhanvantari Nagar, , India
Riyadh/Mena, , Saudi Arabia
Dubai, , United Arab Emirates
Dehradun, , India
Caba, , Argentina
Appleton, Wisconsin, United States
Köln, , Germany
Medellin, , Colombia
Ciudad Autonoma De Buenos Aires, , Argentina
Jinzhou, , China
Suining Shi, , China
Xian, , China
Xuzhou, , China
Tallin, , Estonia
Saint Priest En Jarez, , France
Belgavi, , India
Lima, , Peru
Yong Kang City, , Taiwan
Guilford, , United Kingdom
São Paulo, , Brazil
Shaoguan Shi, , China
Baden, , Switzerland
Plainfield, Illinois, United States
Hooksett, New Hampshire, United States
Larissa, , Greece
Salgotarjan, , Hungary
Manresa, , Spain
Brighton, , United Kingdom
Shantou, , China
Richmond, , Australia
Binzhou, , China
Tuxtla Gutiérrez, , Mexico
Kaohsiung, , Taiwan
Cigli, , Turkey
Abu Dhabi, , United Arab Emirates
Al Ain, , United Arab Emirates
Dubai, , United Arab Emirates
Recife, , Brazil
Adelaide, , Australia
Gateshead, , Australia
Shepparton, , Australia
Wangaratta, , Australia
Warnnambool, , Australia
Lyon, , France
Hamm, , Germany
Waterford, , Ireland
Leon, , Spain
Málaga, , Spain
Sant Joan Despí, , Spain
La Chaux De Fonds, , Switzerland
Manchester, New Hampshire, United States
Sao Paulo, , Brazil
Greenlawn, New York, United States
Shandong, , China
Piraeus, , Greece
Otopeni, , Romania
Abu Dhabi, , United Arab Emirates
Shangqiu, , China
Kozhikode, , India
Estado De México, , Mexico
Al Ain, , United Arab Emirates
New Taipei City, , Taiwan
Bengbu, , China
Yokohama City, , Japan
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported