Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This trial will study a type of breast cancer defined by the expression of hormone receptor in the cancer cells (HR+). Patients will be treated with ribociclib, a cyclin-dependent kinase inhibitor, and camizestrant, a selective estrogen receptor degrader (SERD) and complete ER antagonist. The main purpose of the Study is to analyze the efficacy (to find out how effective a treatment is) of ribociclib in combination with camizestrant in patients with advanced HR+ breast cancer who have received endocrine therapy (ET) in early breast cancer setting for at least 5 years, of which at least 2 years with aromatase inhibitor (AI). Ribociclib plus camizestrant efficacy will be determined by assessing the period from treatment initiation until disease progression, defined as progression free survival (PFS). The anticipated favorable clinical benefits of the combination of ribociclib and camizestrant therapy are projected to outweigh the risks of this treatment. This Study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Musi rozumieć cel badania i podpisać zgodę na uczestnictwo przed rozpoczęciem badania.
- •Wiek co najmniej 18 lat w momencie podpisania zgody.
- •Kobiety przed lub w okresie menopauzy oraz mężczyźni leceni hormonalnie (LHRH) - leczenie powinno trwać co najmniej 28 dni przed badaniem.
- •Kobiety po menopauzie - potwierdzonych brakiem miesiączki przez 12 miesięcy lub chirurgicznym usunięciem jajników.
- •Potwierdzony histologicznie rak piersi wrażliwy na hormony (HR+) i nieposiadający receptora HER2.
- •Zaawansowana lub nawracająca choroba potwierdzena obrazowaniem (CT lub MRI), której nie można operacyjnie wyleczyć.
- •Co najmniej 5 lat leczenia hormonalnego, w tym minimum 2 lata inhibitorami aromatazy.
- •Potwierdzony postęp choroby podczas lub w ciągu 12 miesięcy po zakończeniu leczenia hormonalnego.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- May 29, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (16)
Städtisches Klinikum Dessau
Dessau, Germany
Hospital General Universitario Dr. Balmis
Alicante, Spain
Hospital Clínic Barcelona
Barcelona, Spain
Hospital Dexeus
Barcelona, Spain
Institut Català d'Oncologia Girona - ICO Girona
Girona, Spain
HU Virgen de las Nieves
Granada, Spain
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, Spain
Hospital Universitario de León
León, Spain
Beata Maria Ana
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital Regional Universitario de Málaga
Málaga, Spain
Sant Joan de Reus
Reus, Spain
H Quirónsalud Sagrado Corazón
Seville, Spain
Hospital Universitario y Politécnico de La Fe
Valencia, Spain
HUAV Valencia
Valencia, Spain
IVO - Instituto Valenciano de Oncología
Valencia, Spain
Trial contact
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.