Breast cancer treatment study: camizestrant vs. standard therapy

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    What is this study about?

    This study is looking at a new drug called camizestrant for adults with a certain type of early breast cancer (ER+/HER2-). It compares camizestrant with standard endocrine therapies like tamoxifen and aromatase inhibitors in patients who have already received 2–5 years of endocrine therapy. The study’s focus is on preventing cancer recurrence over 60 months. About 4300 participants are involved, and the trial features an open-label design, meaning everyone knows which treatment they are receiving. The main goal is to check how well the camizestrant works in comparison to standard treatments.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Graz , Austria

      Innsbruck , Austria

      Klagenfurt , Austria

      Kufstein , Austria

      Linz , Austria

      St. Veit an der Glan , Austria

      Steyr , Austria

      Vienna , Austria

      Voecklabruck , Austria

      Wein , Austria

      Wels , Austria

      Wien , Austria

      Wien , Austria

      Wien , Austria

      Brasschaat , Belgium

      Brussel , Belgium

      Edegem , Belgium

      Gent , Belgium

      Leuven , Belgium

      Liege , Belgium

      Mons , Belgium

      Ottignies , Belgium

      Wilrijk , Belgium

      Yvoir , Belgium

      Dobrich , Bulgaria

      Plovdiv , Bulgaria

      Plovdiv , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Vratsa , Bulgaria

      Horovice , Czechia

      Pardubice , Czechia

      Pragues , Czechia

      Praha 4 , Czechia

      Angers Cedex 01 , France

      Argenteuil , France

      Avignon , France

      Bordeaux Cedex , France

      Bordeaux Cu00e9dex , France

      Bourg en Bresse , France

      Caen cedex 05 , France

      Cholet , France

      Clermont Ferrand , France

      Dijon , France

      Epagny Metz-Tessy , France

      Lille , France

      Lorient cedex , France

      Lyon , France

      Marseille , France

      Metz Cedex 03 , France

      Montpellier , France

      Montpellier , France

      Nantes , France

      Nimes , France

      Paris , France

      Paris , France

      Pierre Benite , France

      Plerin SUR MER , France

      Poitiers , France

      Quimper Cedex , France

      Rennes , France

      Saint Cloud , France

      Saint Herblain Cedex , France

      Suresnes Cedex , France

      Toulouse Cedex 09 , France

      Tours CEDEX , France

      Villejuif Cedex , France

      Villejuif , France

      Aachen , Germany

      Augsburg , Germany

      Bayreuth , Germany

      Berlin , Germany

      Berlin , Germany

      Bonn , Germany

      Dessau-Rosslau , Germany

      Dresden , Germany

      Dresden , Germany

      Du00fcsseldorf , Germany

      Eggenfelden , Germany

      Esslingen , Germany

      Georgsmarienhuette , Germany

      Guetersloh , Germany

      Hamburg , Germany

      Hamburg , Germany

      Heidelberg , Germany

      Kiel , Germany

      Landshut , Germany

      Luebeck , Germany

      Mainz , Germany

      Memmingen , Germany

      Mu00fcnchen , Germany

      Ravensburg , Germany

      Ru00fcsselsheim am Main , Germany

      Stralsund , Germany

      Torgau , Germany

      Trier , Germany

      Ulm , Germany

      Velbert , Germany

      Wiesbaden , Germany

      Wiesbaden , Germany

      Worms , Germany

      Wuppertal , Germany

      Athens , Greece

      Athens , Greece

      Athens , Greece

      Chaidari , Greece

      Heraklion , Greece

      Ioannina , Greece

      Rio , Greece

      Thessaloniki , Greece

      Thessaloniki , Greece

      Thessaloniki , Greece

      Budapest , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Debrecen , Hungary

      Gyula , Hungary

      Gyu0151r , Hungary

      Kaposvu00e1r , Hungary

      Miskolc , Hungary

      Nyu00edregyhu00e1za , Hungary

      Szekszu00e1rd , Hungary

      Szolnok , Hungary

      Bari , Italy

      Catania , Italy

      Catanzaro , Italy

      Firenze , Italy

      Genova , Italy

      Grosseto , Italy

      Milano , Italy

      Milan , Italy

      Modena , Italy

      Napoli , Italy

      Napoli , Italy

      Pisa , Italy

      Reggio Emilia , Italy

      Roma , Italy

      Rozzano , Italy

      Turin , Italy

      Dirksland , Netherlands

      Geleen , Netherlands

      Groningen , Netherlands

      Hoofddorp , Netherlands

      Rotterdam , Netherlands

      Rotterdam , Netherlands

      Biau0142ystok , Poland

      Grudziadz , Poland

      Koszalin , Poland

      Lublin , Poland

      Opole , Poland

      Poznau0144 , Poland

      Racibu00f3rz , Poland

      Rzeszu00f3w , Poland

      Warszawa , Poland

      Wieliszew , Poland

      u0141u00f3du017a , Poland

      Amadora , Portugal

      Braga , Portugal

      Guimaru00e3es , Portugal

      Lisboa , Portugal

      Lisboa , Portugal

      Matosinhos , Portugal

      Porto , Portugal

      Porto , Portugal

      Porto , Portugal

      Vila Nova de Gaia , Portugal

      Baia Mare , Romania

      Brasov , Romania

      Cluj-Napoca , Romania

      Constanta , Romania

      Craiova , Romania

      Craiova , Romania

      Craiova , Romania

      Floresti , Romania

      Iasi , Romania

      Oradea , Romania

      Pitesti , Romania

      Sibiu , Romania

      Timisoara , Romania

      Timisoara , Romania

      A Coruu00f1a , Spain

      A Coruu00f1a , Spain

      Albacete , Spain

      Alcoy , Spain

      Alicant , Spain

      Alzira , Spain

      Badajoz , Spain

      Badalona , Spain

      Badalona , Spain

      Barakaldo , Spain

      Barcelona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Cu00e1ceres , Spain

      Elche(Alicante) , Spain

      Galdakao , Spain

      Gerona , Spain

      Granada , Spain

      Granada , Spain

      Jerez De La Frontera (Cu00e1diz) , Spain

      L’Hospitalet de Llobregat , Spain

      Leganu00e9s , Spain

      Lu00e9rida , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Majadahonda , Spain

      Manresa , Spain

      Murcia , Spain

      Oviedo , Spain

      Parla , Spain

      Puerto De Sagunto , Spain

      Reus,Tarragona , Spain

      Salamanca , Spain

      San Juan de Alicante , Spain

      San Sebastiu00e1n , Spain

      Santander , Spain

      Sevilla , Spain

      Sevilla , Spain

      Sevilla , Spain

      Teruel , Spain

      Toledo , Spain

      Valencia , Spain

      Valencia , Spain

      Valencia , Spain

      Brighton , United Kingdom

      Burton-on-Trent , United Kingdom

      Cambridge , United Kingdom

      Derby , United Kingdom

      Edinburgh , United Kingdom

      Guildford , United Kingdom

      Ipswich , United Kingdom

      Keighley , United Kingdom

      London , United Kingdom

      London , United Kingdom

      Manchester , United Kingdom

      Oxford , United Kingdom

      Peterborough , United Kingdom

      Stoke on Trent , United Kingdom

      Sutton , United Kingdom

      You can join this study in:

      Germany: Aachen, Augsburg, Bayreuth, Berlin, Bonn, Dessau-Roßlau, Dresden, Eggenfelden, Georgsmarienhütte, Gütersloh, Hamburg, Heidelberg, Kiel, Landshut, Mainz, Memmingen, Ravensburg, Rüsselsheim am Main, Stralsund, Torgau, Trier, Ulm, Velbert, Wiesbaden, Worms, Wuppertal.

      Spain: Albacete, Alcoy, Alicante, Alzira, Badajoz, Badalona, Barakaldo, Barcelona, Cáceres, Galdakao, Granada, Madrid, Majadahonda, Manresa, Murcia, Oviedo, Parla, Puerto De Sagunto, Salamanca, Sant Joan d’Alacant, Santander, Teruel, Toledo.

      Portugal: Amadora, Braga, Matosinhos, Porto, Vila Nova de Gaia.

      France: Argenteuil, Avignon, Bourg-en-Bresse, Cholet, Clermont-Ferrand, Dijon, Épagny-Metz-Tessy, Lille, Lyon, Marseille, Montpellier, Nantes, Paris, Poitiers, Rennes, Villejuif.

      Romania: Baia Mare, Brașov, Constanța, Craiova, Florești, Iași, Oradea, Pitești, Sibiu.

      Italy: Bari, Catania, Catanzaro, Grosseto, Milan, Modena, Pisa, Reggio Emilia, Rozzano, Turin.

      Belgium: Brasschaat, Edegem, Leuven, Liège, Mons, Wilrijk, Yvoir.

      United Kingdom: Brighton and Hove, Burton upon Trent, Cambridge, Derby, Edinburgh, Guildford, Ipswich, Keighley, Manchester, Oxford, Peterborough, Sutton.

      Hungary: Budapest, Debrecen, Gyula, Miskolc, Szolnok.

      Greece: Chaidari, Heraklion, Ioannina, Rio, Thessaloniki.

      Netherlands: Dirksland, Geleen, Groningen, Hoofddorp, Rotterdam.

      Bulgaria: Dobrich, Plovdiv, Sofia, Vratsa.

      Austria: Graz, Innsbruck, Kufstein, Linz, Sankt Veit an der Glan, Steyr, Vienna, Vöcklabruck, Wels.

      Poland: Grudziądz, Koszalin, Lublin, Opole, Racibórz, Wieliszew.

      Czechia: Hořovice, Pardubice.


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      In this clinical trial, patients will be randomized in a 1:1 ratio to one of two treatment arms:

      1. Arm A: Continue standard endocrine therapy (ET) of the investigator’s choice, which includes aromatase inhibitors (AI; exemestane, letrozole, anastrozole) or tamoxifen.
      2. Arm B: Receive the drug camizestrant.

      The planned duration of treatment in either arm of the study is 60 months.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      Based on the eligibility criteria, you need to have the following disease to potentially qualify for this study:

      • 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.

      In simpler terms, you must have early-stage breast cancer that is:

      • Estrogen receptor positive (ER+)
      • Human epidermal growth factor receptor 2 negative (HER2-)
      • Surgically removed
      • Considered to have a high or intermediate risk of coming back based on clinical and pathological features

      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      To join this clinical trial, you must meet the following key inclusion criteria:

      Age and Gender:

      • Women and men, aged 18 years or older at the time of screening (or per national guidelines)

      Breast Cancer Diagnosis:

      • Confirmed ER-positive/HER2-negative (ER+/HER2-) early-stage breast cancer that has been surgically removed
        • ER-positive means the cancer cells have estrogen receptors
        • HER2-negative means the cancer cells do not have high levels of HER2 protein
      • High or intermediate risk of the cancer returning, based on clinical and pathological features

      Prior Treatment:

      • Completed appropriate local therapy (surgery with or without radiation) for the primary breast tumor(s), with or without chemotherapy before or after surgery
      • Completed at least 2 years but no more than 5 years and 3 months of adjuvant endocrine therapy (anti-estrogen treatment), with or without CDK4/6 inhibitor drugs

      Health Status:

      • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
        • ECOG is a scale used to assess how a patient’s disease is progressing and how the disease affects their daily living abilities
        • 0 means fully active, able to carry on all pre-disease activities without restriction
        • 1 means restricted in physically strenuous activity but able to carry out light work
      • Adequate organ and bone marrow function, as determined by blood tests

      Meeting with your oncologist is the best way to determine if you qualify for this study based on your individual medical situation and the full eligibility criteria.

      What Reasons Could Exclude Me from the Study?

      Based on the eligibility criteria, you cannot take part in the study if you have any of the following:

      Cancer-related exclusions:

      • Inoperable locally advanced or metastatic breast cancer – breast cancer that has spread outside the breast and cannot be surgically removed
      • Pathological complete response following neoadjuvant therapy – no signs of cancer in breast tissue or lymph nodes after pre-surgery treatment
      • History of another cancer in the past 5 years (except non-melanoma skin cancer or cervical carcinoma in situ considered very low risk)

      Medical conditions:

      • Severe or uncontrolled systemic diseases that would prevent study participation per investigator judgment
      • Left ventricular ejection fraction (LVEF) less than 50% with heart failure NYHA Grade 2 or higher. LVEF measures how much blood the left ventricle of the heart pumps out.
      • QTcF interval greater than 480 ms at screening. QTcF is a heart rhythm measurement on an ECG.

      Prohibited medications and hypersensitivity:

      • Current use of hormone therapies not permitted in the study
      • Current anti-cancer treatment not allowed in the study protocol (except certain bone medications)
      • Previous treatment with the study drug camizestrant, similar investigational drugs, or fulvestrant
      • Known hypersensitivity to camizestrant, drugs chemically similar to it, or LHRH agonists

      Other exclusions:

      • Currently pregnant or breastfeeding

      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study and their brief descriptions are as follows:

      1. Camizestrant (AZD9833): This is an experimental drug administered orally. Camizestrant is being studied to see if it improves outcomes compared to standard endocrine therapy in patients with ER+/HER2- early breast cancer.
      2. Tamoxifen: Tamoxifen is a well-established medication used in the treatment of hormone receptor-positive breast cancer. It works by blocking estrogen receptors on cancer cells, which can help to slow or stop the growth of estrogen-dependent tumors.
      3. Anastrozole: Anastrozole is an aromatase inhibitor used to treat breast cancer in women who have gone through menopause. It lowers estrogen levels in the body, which can slow the growth of certain types of breast tumors that need estrogen to grow.
      4. Letrozole: Letrozole is another aromatase inhibitor used to treat postmenopausal women with breast cancer. Similar to anastrozole, it reduces estrogen levels to slow the growth of cancer cells.
      5. Exemestane: Exemestane is also an aromatase inhibitor, and it acts by decreasing the amount of estrogen produced in the body. It is used to treat certain types of breast cancer, like anastrozole and letrozole.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substances participating in the clinical trial are as follows:

      1. Camizestrant (AZD9833)
        Camizestrant is described as experimental and is administered orally in the clinical trial. It is currently being assessed for its efficacy in comparison to standard endocrine therapies.
      2. Tamoxifen
        Tamoxifen is a well-known medication used in the treatment of breast cancer. It is a comparator in the clinical trial and is administered as per the local approved label.
      3. Anastrozole
        Anastrozole, commonly used to treat breast cancer, serves as a comparator substance in the clinical trial and is administered according to the local approved label.
      4. Letrozole
        Letrozole is another medication used in the treatment of breast cancer. It is also a comparator in the clinical trial and administered based on the local approved label.
      5. Exemestane
        Exemestane is administered as a comparator in the clinical trial, in line with the local approved label. It is also used in standard breast cancer treatment.

      All comparator substances—tamoxifen, anastrozole, letrozole, and exemestane—are known to medicine and extensively documented in medical literature for the treatment of breast cancer. Camizestrant is being investigated as a new potential treatment option and is considered experimental in this context.


      Study ID

      CT-EU-00029896

      Recruitment status

      Recruting new patients

      Start of the trial

      1 year ago

      Study phase

      Phase
      III

      Diseases