A Study of Camizestrant Compared to Standard Hormone Therapy for Patients with ER-Positive HER2-Negative Early Breast Cancer After Initial Treatment

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What is this study about?

This study is looking at a type of breast cancer called ER-positive HER2-negative early breast cancer. This means the cancer cells have receptors for the hormone estrogen but do not have high levels of a protein called HER2. The study is specifically for people who have an intermediate-high or high chance of the cancer coming back after they have completed their initial treatment, including surgery and possibly radiation, and who currently show no signs of disease. The main treatment being tested is camizestrant, which is also known by its code name AZD9833. This is a newer type of medicine that works by breaking down estrogen receptors in cancer cells. Camizestrant will be compared to standard hormone treatments, which include medicines called aromatase inhibitors such as anastrozole, letrozole, and exemestane, or a medicine called tamoxifen. Some people in the study may also receive an additional medicine called abemaciclib. For people who have not gone through menopause, treatment with medications called goserelin, triptorelin, or leuprorelin acetate may be given to stop the ovaries from making hormones.

The purpose of this study is to find out if camizestrant, either alone or combined with abemaciclib, works better than standard hormone treatments, either alone or combined with abemaciclib, in preventing breast cancer from coming back. The study will measure how long people remain free from invasive breast cancer returning. People taking part in this study will be assigned by chance to receive either camizestrant or one of the standard hormone treatments. The treatment will continue for a period of time, and people will be monitored regularly to check how well the treatment is working and to watch for any unwanted effects.

During the study, doctors will check for any side effects that occur, perform blood tests, and measure vital signs like blood pressure and heart rate. People in the study will also be asked questions about their quality of life and how the side effects of treatment affect them in their daily lives. Blood samples may be taken to measure the amount of camizestrant in the blood. The study will track whether the cancer comes back, spreads to other parts of the body, or if a new cancer develops, as well as overall survival.

1 Treatment assignment

After joining the study, you will be assigned to one of the treatment groups. The assignment will be done randomly, which means neither you nor your doctor can choose which group you will be in.

You may receive either camizestrant (a new type of medicine that blocks estrogen receptors) or standard endocrine therapy (which includes medicines called aromatase inhibitors or tamoxifen). Some patients may also receive an additional medicine called abemaciclib.

2 Treatment with medicines

The treatment will depend on which group you are assigned to. All medicines in this study are taken by mouth as tablets, except for some hormone-suppressing medicines which may be given as injections into the muscle or under the skin.

If you receive camizestrant, you will take it orally as a tablet. The exact dosage and frequency will be determined by the study protocol.

If you receive standard endocrine therapy, you may take one of the following medicines orally: anastrozole (such as Arimidex 1 mg tablet), letrozole, exemestane, or tamoxifen citrate (such as Nolvadex 20 mg tablet). These medicines work by either blocking estrogen production or blocking estrogen from affecting breast cancer cells.

Some patients may also need to take medicines that suppress hormone production from the ovaries. These include triptorelin, leuprorelin acetate, or goserelin, which are given as injections into the muscle or under the skin.

If you are assigned to receive abemaciclib in addition to the main treatment, you will take it orally as a tablet.

The treatment period is expected to last for several years, as this is an adjuvant therapy designed to prevent cancer from returning after your initial treatment.

3 Regular monitoring visits

Throughout the study, you will have regular visits to monitor your health and the effects of the treatment.

During these visits, blood samples will be taken to check your organ function and blood cell counts, and to measure the levels of the study medicine in your blood.

Your vital signs, such as blood pressure and heart rate, will be measured at each visit.

You will be asked about any side effects or health problems you have experienced since your last visit.

4 Quality of life assessments

At certain times during the study, you will be asked to complete questionnaires about your quality of life and any side effects you are experiencing.

These questionnaires will ask about your physical well-being, emotional state, and how the treatment is affecting your daily activities.

The information you provide will help assess how the treatment impacts your overall well-being.

5 Long-term follow-up

The study will continue for many years to monitor whether the breast cancer returns and to track your overall health.

You will continue to have regular follow-up visits even after you complete the active treatment phase.

The study is expected to continue until 2037, although your individual participation may vary depending on your response to treatment and overall health.

6 Reporting side effects

Throughout your participation, it is important to report any new symptoms, health problems, or side effects to your study doctor.

Any serious health events will be carefully documented and assessed to ensure your safety during the study.

Who Can Join the Study?

  • You must be a woman or man who is 18 years of age or older at the time of joining the study
  • You must have ER positive and HER2 negative early-stage breast cancer that has been confirmed by tissue examination under a microscope and has been removed by surgery. ER positive means your cancer grows in response to the hormone estrogen. HER2 negative means your cancer does not have too much of a specific protein called HER2. There must be no signs that the cancer has spread to other parts of your body
  • You must have completed appropriate local treatment for your breast cancer, which includes surgery with or without radiation therapy. Radiation therapy uses high-energy rays to destroy cancer cells. You may or may not have received chemotherapy, which is medicine that kills cancer cells, either before or after surgery
  • You must join the study within 12 months after your breast surgery. You may have received up to 12 weeks of hormone therapy, which is treatment that blocks hormones that help cancer grow, either after surgery or before surgery
  • You must have an ECOG performance status of 1 or lower. This is a scale that measures how well you can carry out daily activities, where 0 means you are fully active and 1 means you have some restrictions but can do light work
  • Your body organs and bone marrow, which is the soft tissue inside bones that makes blood cells, must be working well enough based on laboratory test results

Who Cannot Join the Study?

  • The source data does not provide specific exclusion criteria, which are the reasons why a patient cannot participate in the study
  • Without detailed exclusion criteria listed in the trial information, it is not possible to identify which medical conditions, treatments, or other factors would prevent someone from joining this study
  • Typically, exclusion criteria might include things like other types of cancer, certain medical conditions, previous treatments, or laboratory test results that fall outside acceptable ranges, but these specific details are not available in the provided information

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name City Country Status
Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
Landeskrankenanstalten-Betriebsgesellschaft Kabeg Klagenfurt am Wörthersee Austria
Institut Jules Bordet Anderlecht Belgium
General University Hospital Of Larissa Larissa Greece
IRCCS Humanitas Research Hospital Rozzano Italy
University Of Debrecen Debrecen Hungary
Laiko General Hospital Of Athens Athens Greece
Institut Paoli-Calmettes Cancer Centre Marseille France
Hospital Vall d’Hebron Barcelona Spain
North Estonia Medical Centre Foundation Tallin Estonia
Beaumont Hospital Dublin Ireland
Hospital Universitario da A Coruna A Coruna Galicia Spain
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Virgen del Rocío University Hospital Sevilla Spain
Fakultni nemocnice Motol a Homolka Prague Czechia
Ospedale San Raffaele S.r.l. Milan Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. Meldola Italy
Medical University Of Vienna Vienna Austria
Fakultni Nemocnice Brno Brno Czechia
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Medical University Of Graz Graz Austria
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
IRCCS Ospedale Policlinico San Martino Genoa Italy
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Hospital Universitario De Salamanca Salamanca Spain
Hospital Clinico San Carlos Madrid Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Azienda Ospedaliera Universitaria Citta’ Della Salute E Della Scienza Di Torino Turin Italy
Johannes Kepler University Linz Austria
Gasthuiszusters Antwerpen Antwerp Belgium
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
General University Hospital Of Patras Patras Greece
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Complex Oncological Center – Shumen EOOD Shumen Bulgaria
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Medical University Of Graz Graz Austria
University Of Szeged Szeged Hungary
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
KBC Split Split Croatia
Uniwersyteckie Centrum Kliniczne Gdansk Poland
Hospital De La Santa Creu I Sant Pau Barcelona Spain
St Vincent’s University Hospital Dublin Ireland
Medizinische Universitaet Innsbruck Innsbruck Austria
Centre Leon Berard Lyon France
University Of Antwerp Edegem Belgium
Azienda Ospedaliera Papa Giovanni XXIII Bergamo Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Centre Hospitalier Universitaire De Nimes Nimes France
Institut Gustave Roussy Villejuif France
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Ospedaliero Universitaria Careggi Florence Italy
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France
Universita Degli Studi Di Roma La Sapienza Rome Italy
Ordensklinikum Linz GmbH Linz Austria
Katholieke Universiteit te Leuven Leuven Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Universitaetsklinikum Aachen AöR Aachen Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Institut Catala D’oncologia L'hospitalet De Llobregat Spain
Servei De Salut De Les Illes Balears Palma Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Hospital Universitario Hm Sanchinarro Madrid Spain
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
University General Hospital Of Heraklion Heraklion Greece
Complexo Hospitalario Universitario De Vigo Vigo Spain
Complex Oncological Center Plovdiv EOOD Plovdiv Bulgaria
Hospital Universitario Virgen De Las Nieves Granada Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Institut Curie – Site Paris Paris France
Hospital Universitario Virgen De La Victoria Malaga Spain
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Istituto Oncologico Veneto Padua Italy
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Parc Tauli Hospital Universitari Sabadell Spain
Institut Regional Du Cancer De Montpellier Montpellier France
KBC Zagreb Zagreb Croatia
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Centre Henri Becquerel Rouen France
Centre Jean Perrin Clermont Ferrand France
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej Biala Podlaska Poland
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
Mbal Za Zhensko Zdrave Nadezhda OOD Sofia Bulgaria
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Tolna Vármegyei Balassa János Kórház Szekszard Hungary
Specjalistyczny Szpital Onkologiczny Nu-Med Sp. z o.o. Tomaszow Mazowiecki Poland
Orszagos Onkologiai Intezet Budapest Hungary
Bacs-Kiskun Varmegyei Oktatokorhaz Kecskemet Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Theageneio Cancer Hospital Thessaloniki Greece
Clinical Medical Center Osijek Osijek Croatia
Spitalul Clinic Filantropia Bucharest Romania
Centre Oscar Lambret Lille France
Institut de Cancérologie Hématologie Universitaire de Saint Etienne (iCHUSE) Saint Priest En Jarez France
Centre Francois Baclesse Caen France
Comite Entreprise Paul Papin Angers France
Tartu University Hospital Tartu Estonia
Hospital Universitario De Cruces Barakaldo Spain
University Hospital Galway Galway Ireland
Hospital Universitario De Leon Leon Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Hospital Universitario Virgen De Valme Sevilla Spain
Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary
Hospital Universitario Donostia Donostia / San Sebastian Spain
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Klinik Hietzing Vienna Austria
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Hospital Universitario De Canarias La Laguna Spain
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Azienda Provinciale Per I Servizi Sanitari Trento Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Hospital General Universitario Morales Meseguer Murcia Spain
Cork University Hospital Cork Ireland
Hospital San Pedro De Alcantara Caceres Spain
Area De Salud De Burgos Y Soria Burgos Spain
Grand Hopital De Charleroi Charleroi Belgium
University Hospital Waterford Waterford Ireland
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii Wroclaw Poland
AZ Sint-Lucas & Volkskliniek Gent Belgium
Unidade Local De Saude De Amadora Sintra E.P.E. Amadora Portugal
SCRI CCCIT Ges.m.b.H. Salzburg Austria
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD Sofia Bulgaria
Consorcio Hospitalario Provincial De Castellon Castello De La Plana Spain
Hospital Universitario De Fuenlabrada Fuenlabrada Spain
Instytut Msf Sp. z o.o. Lodz Poland
Kliniken Essen-Mitte,Evangelische Huyssens-Stiftung Essen Germany
Hospital Universitario Hermanos Trias y Pujol. Institut Catalá d’Oncología (ICO) Badalona Spain
Hospital Jerez de la Frontera Jerez De La Frontera Spain

Other Sites

Site Name City Country Status
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A. Athens Greece
Helios Universitaetsklinikum Wuppertal Wuppertal Germany
Klinikum Wels-Grieskirchen GmbH Wels Austria
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Zachodniopomorskie Centrum Onkologii Szczecin Poland
Opca Bolnica Zadar Zadar Croatia
NH Hospital a.s. Horovice Czechia
MVZ Onko Medical GmbH Hannover Hanover Germany
Klinički bolnički centar Zagreb (University Hospital Center Zagreb) Zagreb Croatia
Krajska nemocnice Liberec a.s. Liberec Czechia
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
L’Hopital Prive Du Confluent Nantes France
Mater Private Hospital Dublin Ireland
Albertinen-Krankenhaus/Albertinen-Haus gGmbH Hamburg Germany
Klinikum Worms gGmbH Worms Germany
DRK Kliniken Berlin Berlin Germany
Multidisciplinary Hospital For Active Treatment Haskovo AD Haskovo Bulgaria
Ortenau Klinikum Offenburg Germany
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie Koszalin Poland
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Mruk-Med I Sp. z o.o. Rzeszow Poland
Hospital General Universitario De Albacete Albacete Spain
European Interbalkan Medical Center Thessaloniki Greece
Azorg Aalst Belgium
Fzgptcqzou Hkauftzu Hwvoxfofab Georgsmarienhütte Germany
Ukmeymnern Ghzspih Hjgefdpj Om Igdpynpu Ioannina Greece
Cdboro Ozqddlmloi Dm Ghbxblb A Coruna Galicia Spain
Bomuresxeakyfzytuwxl Vbftkjrxh Kbetmfqpb Kmosly Eu Ezecqgqc Olpnpicvwvfm Miskolc Hungary
Sriqt Samd Jpfn Di Ruiw Reus Spain
Aceelarj Zvljdfjogk Kijnp Brasschaat Belgium
Cznscv Hidjoorboii Upimzfgmsvboh Dtwmzn Gkfkybo Sxmfrcemyjqkbanhbiskkefsxf Namur Belgium
Stwzllsm Pwjzmarjs Spv z oylm Gdynia Poland
Mth Mkaodgm Cwpaso Dqnehzbfhgc Gvxv Duesseldorf Germany
Mqjpfv Hooombsw Wbicyu Witten Germany
Hlpwboww Clx Plvrd Sivg Porto Portugal
Owfifkqayxhf Szfqyhoouqexngwmf Smkxlt Speyer Germany
Kwxjauqc dwy Snmlh Kenvb guhpv Cologne Germany
Ckzuxeuu Sazuorpl Iyrcohjm L'hospitalet De Llobregat Spain
Hphafm Dag Hbymv Sswkwii Kjyddjrc Wswgbhwyr Gmpq Wiesbaden Germany
Cijsxoi Tjnalkwornxadyhvzjk Sofaamstqobt moj (nsps Saarbrücken Germany
Dnfjcglom Kseotdyaojq gmddt Hanover Germany
Oczl Crhvpr Cloabne Sgao Craiova Romania
Mblzim Cgtuks Cmetkf Hgepkghk Oz Pjcgciu Piraeus Greece
Sbjjkgkuxm Erjqylz Budapest Hungary
Caljko Hyffxbapttc Aiuotc Ggmuhwgb Epagny Metz Tessy France
Icsk Gqycc Filothei Greece
Nhd Lfo Gdbhliazjy Thvtnovotguwa Gzxj Wiener Neustadt Austria
Gwvflae Hnzfmvpt Oe Taulgbwxawef Pviklrfdlqwd Thessaloniki Greece
Vjexz Cpplbqzipng Kkyghnkx Knjcxaaeh Karlsruhe Germany
Ktssludgnzwwcd Sujicaxojg Hltel Bjfdtaeemmqwkdzaarpaujk Vienna Austria
Mzdffwobs supvgv Pardubice Czechia
Mrqlruf Crrvbl Rtxekm Luae Cipvti Lbdy Sofia Bulgaria
Kwxoqova Sajrpccue Rqsrmlx Rostock Germany
Wktqtexxpaz Kcvpktfttbplwv Gkix Vienna Austria
Opcthah Szvivd Timisoara Romania
Mhcxemythisr Hexlmtev Feg Axahze Tsmqxwfjt Depmwng Au Dobrich Bulgaria
Hyvprbxw Vgyhrg Pezadp Sxh Ajityhk Malaga Spain
Hesadbp Pgkot Dtq Chskt Dvjlhqnqdyoed Plerin France
Sru Lbbfeogrmnbo Hbmderua Syss Thessaloniki Greece
Dgjtvmhlu Kkkvtrck Djdovpvsfwwuyqydvntvkttrdveo gmv Deggendorf Germany
Eowg Tnkwsyc Ctjwqrs Hrjdkgem Tallin Estonia
Gbby Mxtfkzq Sbzlza Bucharest Romania
Apfrylh Hoxanuqc Athens Greece
Rjqnhqorr Tegifjqcbkh Crizil Seqcag Otopeni Romania
Srtyrpho Dj Onumlozkz Mfybg Svoglm Bucharest Romania
Lozictbioiypgcyfbirtie dma Siqih Ssfuodbcwfk Gefn Schweinfurt Germany
Keynudgxoohtptel Twyldj Jcsnhu Kqdcjxxo gudkr Torgau Germany
Syhoevbtefuh Kmmlrkjv Dwtstj Dessau-Roßlau Germany
Unmgopn Logol Ds Sfipp Du Gplaeyccyjhi Ekwfmn Vila Nova De Gaia Portugal
Sboyb Scdhku Ooivohdj Hzqftjku Athens Greece
Kgplmslu Dsntglfyz Gijp Darmstadt Germany
Irybhvoo Fdcl Vtqkjaznnhrcflqdytii Ik Dst Odqobvfub Gif Koblenz Germany
Oycsbluh Cxlonjz Oseredfrq Iqy Phzji Tpdvpttx Kdurrazipowpqv W Oesbs Sreldtwgzqq Pdcfvlzkx Zufoxo Okecso Zjlcqpxqhe Opole Poland
Ortjclstonq Dlsdrlj Feubfkgk Msofhwc Dresden Germany
Ohgnpot Sshdiu Craiova Romania
Hjryopatq Ikynlhce Ctyyfmc Copnkuul Srvomq Misterbianco Italy
Hgtudlms Ckj Dxuwirdzpmj Snts Lisbon Portugal
Rylzpfsuwicg Cejghu Cfsu Sxevtu Floresti Romania
Nusfvm Vcazwzgny Sqoya Lnuab Klvgmm Salgotarjan Hungary
Cytpubw Mnobcenc Hup Sqe z ovxo Poznan Poland
Uttagmq Lcliu Du Sfyrn Dg Amdg Mnjwu Ekzegx Ponte De Lima Portugal
Mz Alhwdyzz Cwjptn Crjvqd Madrid Spain
Shsssxu Rlqojvaf Iax Dp Jzzhob Rklneq W Rgijpalmx Raciborz Poland
Bknwdbnmrzgm Cajzgbm Omspsaldx Ihj Muwxr Suywlwbimchbrnxyhv W Bagmkmkrcuh Bialystok Poland
Sxa Jcdclbcvdmjxxwf Woxnsnlcm Gthj Wiesbaden Germany
Ohksqyn Crsqhejo Hchdzfdr Smgjjh Ovidiu Romania
Wzlsjcduja Sogcjwk Sqlnlpilsdornlu Ieb Spklkkp Kffgjzwnq Wftwhhjkvwpi Stcowljbsnk Povyraokh Zuhyif Orhbbu Zzpneoactl W Lcgjywht Lublin Poland
Rcjjsqssio Szghese Ssqtagpkoipioor Izp Dms Wzkbmicvfn Bnghyiwyvhhp Grudziadz Poland
Aeenbup Xaefg Akjyxybybueb Uteaukukmvrvq Dk Muszihl Firtkqnu Psioreq Manresa Spain
Myjqsftkipar Hsihnot Mqm Gdl Hamburg Germany
Iyzxdbdd Di Clrtryzptyok Dz L Oadwm Saint-Herblain France
Oalwybilpu Vougvk Wlqpo St. Veit An Der Glan Austria
Gbttwkaqgzqcndadf Veyoepvbl Pjhp Aafiqb Eaxdshkl Owrwxtyubbwma Oabqvodyfoxdafs Olehdym Gyor Hungary

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
10.03.2024
Belgium Belgium
Not recruiting
10.03.2024
Bulgaria Bulgaria
Not recruiting
10.03.2024
Croatia Croatia
Not recruiting
10.03.2024
Czechia Czechia
Not recruiting
10.03.2024
Estonia Estonia
Not recruiting
10.03.2024
France France
Not recruiting
10.03.2024
Germany Germany
Not recruiting
10.03.2024
Greece Greece
Not recruiting
10.03.2024
Hungary Hungary
Not recruiting
10.03.2024
Ireland Ireland
Not recruiting
10.03.2024
Italy Italy
Not recruiting
10.03.2024
Poland Poland
Not recruiting
10.03.2024
Portugal Portugal
Not recruiting
10.03.2024
Romania Romania
Not recruiting
10.03.2024
Spain Spain
Not recruiting
10.03.2024

Trial locations

Camizestrant is an oral medication that works by breaking down estrogen receptors in the body. Estrogen receptors are proteins found on breast cancer cells that help the cancer grow when they attach to estrogen. By removing these receptors, this medication aims to prevent breast cancer from coming back after initial treatment.

Abemaciclib is an oral medication that blocks certain proteins called CDK4 and CDK6, which help cancer cells divide and grow. By blocking these proteins, this medication helps slow down or stop the growth of cancer cells. In this trial, it may be given in combination with other treatments.

Aromatase inhibitor is a type of hormone therapy medication that lowers the amount of estrogen in the body. Estrogen can fuel the growth of certain types of breast cancer, so reducing estrogen levels helps prevent the cancer from returning. This is one of the standard treatment options used in this trial.

Tamoxifen is a hormone therapy medication that blocks estrogen from attaching to estrogen receptors on breast cancer cells. By preventing estrogen from reaching cancer cells, this medication helps reduce the risk of breast cancer coming back. This is another standard treatment option used in this trial.

Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer – This is a type of breast cancer that is detected in its early stages and has specific characteristics based on laboratory testing of the cancer cells. The cancer cells have receptors for the hormone estrogen on their surface, which means estrogen can promote the growth of these cancer cells. At the same time, these cells do not have an excess of a protein called human epidermal growth factor receptor 2. This particular combination of features affects how the cancer behaves and grows in the body. Early breast cancer means the disease is confined to the breast or nearby lymph nodes and has not spread to distant parts of the body. The cancer may progress over time if not addressed, potentially spreading beyond its original location.

Trial ID:
2023-504031-41-00
Protocol code:
D8535C00001
NCT ID:
NCT05952557
Trial Phase:
Therapeutic confirmatory (Phase III)

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