Study on the Effectiveness and Safety of Saruparib and Camizestrant in Adults with Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

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What is this study about?

This clinical trial is focused on studying treatments for Advanced Breast Cancer, specifically in patients with certain genetic mutations known as BRCA1, BRCA2, or PALB2. The trial will explore the effectiveness and safety of a combination of two medications: Saruparib (also known by its code name AZD5305) and Camizestrant. These medications will be compared to the current standard treatment options, which include a type of medication called CDK4/6 inhibitors combined with Endocrine Therapy or Camizestrant alone. The study aims to determine if the new combination of Saruparib and Camizestrant is more effective in delaying the progression of the disease.

Participants in the study will receive either the new combination treatment or one of the standard treatments, which will be chosen by their doctor. The study will monitor how long the cancer remains stable without getting worse, as well as the overall survival of the participants. The trial will also assess the time it takes for participants to start chemotherapy after the study treatment, the response of the cancer to the treatment, and the duration of any positive response. Additionally, the study will gather information on the side effects experienced by participants, focusing on symptoms like diarrhea and abdominal pain, and how these affect their quality of life.

The trial will also measure the levels of Saruparib and Camizestrant in the blood to better understand how these drugs work in the body. The study is expected to start recruiting participants in late 2024 and will continue until 2030. This research is important for developing new treatment options for people with Advanced Breast Cancer who have specific genetic mutations, and it aims to improve the outcomes and quality of life for these patients.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of advanced breast cancer with certain genetic mutations.

Participants must have adequate organ and marrow function and meet other health requirements.

2 randomization

Participants are randomly assigned to receive either the combination of saruparib and camizestrant or a physician’s choice of CDK4/6 inhibitor plus endocrine therapy or camizestrant.

3 treatment administration

The treatment involves taking medications orally or via intramuscular injection, depending on the assigned group.

Medications include saruparib, camizestrant, and other options such as exemestane, palbociclib, abemaciclib, fulvestrant, anastrozole, letrozole, and ribociclib.

4 monitoring and assessments

Regular monitoring is conducted to assess the progression of the disease and the effectiveness of the treatment.

Assessments include measuring progression-free survival and overall survival, as well as monitoring for any side effects.

5 completion of treatment

The treatment continues until disease progression or unacceptable side effects occur.

The study aims to determine the time to chemotherapy and the duration of response to the treatment.

6 follow-up

After completing the treatment, follow-up visits are scheduled to monitor long-term outcomes and any late side effects.

The study is estimated to conclude by July 18, 2030.

Who Can Join the Study?

  • Participants must be adult females, either before, during, or after menopause, and adult males.
  • Participants must have a confirmed diagnosis of breast cancer that is positive for hormone receptors (HR-positive) and negative for a protein called HER2.
  • Participants must have advanced breast cancer, which means the cancer has spread locally and cannot be cured with treatment, or it has spread to other parts of the body (metastatic).
  • Participants must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not need to stay in bed for more than half of the day.
  • Participants must provide a sample of their tissue that shows a specific type of genetic change called a loss of function mutation in the BRCA1, BRCA2, or PALB2 genes.
  • Participants must have organs and bone marrow that are working well enough to participate in the study.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than Advanced Breast Cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Patients who are not female or male subjects as required by the study cannot participate.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Medizinische Hochschule Hannover Hanover Germany
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie Koszalin Poland
Hospital Universitario De Navarra Pamplona Spain
Hospital Lusiadas Porto Porto Portugal
IRCCS Humanitas Research Hospital Rozzano Italy
Medical University Of Vienna Vienna Austria
Universitaetsmedizin Goettingen Goettingen Germany
Hospital Clinico San Carlos Madrid Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Medical University Of Graz Graz Austria
Universitaet Leipzig Leipzig Germany

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Haematologie-Onkologie im Zentrum MVZ GmbH Augsburg Germany
Orszagos Onkologiai Intezet Budapest Hungary
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Universitaetsklinikum Aachen AöR Aachen Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital Universitario 12 De Octubre Madrid Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Hospital San Pedro De Alcantara Caceres Spain
Fakultni Nemocnice Bulovka Prague Czechia
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E. Coimbra Portugal
Hospital Cuf Descobertas S.A. Lisbon Portugal
Centrum Medyczne Hcp Sp. z o.o. Poznan Poland
Complex Oncological Center Plovdiv EOOD Plovdiv Bulgaria
RKH Klinken Ludwigsburg-Bietigheim gGmbH Ludwigsburg Germany
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E. Vila Real Portugal
Staedtisches Klinikum Dessau Dessau-Roßlau Germany
HELIOS Klinikum Berlin-Buch GmbH Berlin Germany
Mammazentrum Hamburg MVZ GbR Hamburg Germany
Centre Henri Becquerel Rouen France
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej Biala Podlaska Poland
University Of Debrecen Debrecen Hungary
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Erlangen AöR Erlangen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz Miskolc Hungary
Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
University Hospital Olomouc Olomouc Czechia
Kliniki Neuroradiochirurgii Sp. z o.o. Radom Poland
Institut de Cancérologie de l’Ouest Saint-Herblain France
Budapesti Uzsoki Utcai Korhaz Budapest Hungary
Hospital Universitario Virgen De La Victoria Malaga Spain
Smlqeewpar Etzbyjn Budapest Hungary
Cibvpc Lksr Bhmihc Lyon France
Opszqsstvrgygi Lvxp Gbex Linz Austria
Iobrjyul Cyvrgh Dalgjnooiubbetqgy L'hospitalet De Llobregat Spain
Mendgqept sggxxn Horovice Czechia
Coapzup Oysicary Cfwocy Slrgd Zpmmbl Lxfg Stara Zagora Bulgaria
Uhrrosjjnnhzcqlrbuuyf Drvhkrgubiz App Duesseldorf Germany
Bcekayjn Uxofyhafas Hymduzzi Crwwut Besançon France
Uhezsrbfhbyvczbxonoqx Mlhdlvoi Ahu Munster Germany
Npftvkcu Iqfeygjc Odsyuxxqu Imu Mqoxz Skxauqntiubuzjqtgjarrxltprji Ikmktbyf Bkenzlkc Cracow Poland
Aeethyx Urs Isyvd Dl Rizyql Egqxfj Reggio Emilia Italy
Atpueyc Uglli Scemscgbu Ldecbi Db Bvhuwzv Bologna Italy
Aafkbcd Omsbkpdziqs Pfqg Gkakxrsy Xqrcm Bergamo Italy
Hqftcomz Vafs dqhvuoqz Barcelona Spain
Iruedwuf Pukmtclbxqxavpl Cxdmky Cqbvml Marseille France
Cjkhpq Olacq Loodqio Lille France
Ibxrgszz Cgzjt Paris France

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
30.09.2024
Bulgaria Bulgaria
Recruiting
30.09.2024
Czechia Czechia
Recruiting
30.09.2024
France France
Recruiting
30.09.2024
Germany Germany
Recruiting
30.09.2024
Hungary Hungary
Recruiting
30.09.2024
Italy Italy
Recruiting
30.09.2024
Poland Poland
Recruiting
30.09.2024
Portugal Portugal
Recruiting
30.09.2024
Spain Spain
Recruiting
30.09.2024

Trial locations

Saruparib (AZD5305) is an experimental medication being studied for its potential to treat advanced breast cancer. It is being tested in combination with other therapies to see if it can help slow down or stop the progression of cancer in patients with specific genetic mutations.

Camizestrant is a medication used in the treatment of hormone receptor-positive breast cancer. It works by blocking the effects of estrogen, a hormone that can promote the growth of breast cancer cells. In this trial, it is being used in combination with other treatments to evaluate its effectiveness in managing advanced breast cancer.

CDK4/6 Inhibitors are a class of drugs used in cancer treatment that work by interfering with the cancer cell cycle, effectively slowing down or stopping the growth of cancer cells. In this study, they are being used as part of the physician’s choice treatment to compare their effectiveness with other therapies in treating advanced breast cancer.

Advanced Breast Cancer – This is a stage of breast cancer where the disease has spread beyond the initial site to other parts of the body. It often involves the lymph nodes, bones, liver, lungs, or brain. The progression of advanced breast cancer can vary, with some individuals experiencing rapid spread while others may have a slower progression. Symptoms may include persistent pain, fatigue, and changes in breast appearance or size. The disease can lead to complications depending on the organs affected. Management focuses on controlling the spread and alleviating symptoms.

Trial ID:
2023-504180-16-00
Protocol code:
D9722C00001
NCT ID:
NCT06380751
Trial Phase:
Therapeutic confirmatory (Phase III)

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