drugset / Trial / NCT05664893

Study to Determine the Safety and Efficacy of Ribociclib in Combination With Hormone Therapy and Hypofractionated Radiotherapy in Breast Cancer, With Positive Hormone Receptors and Negative HER2 Status, in Newly Diagnosed, Not Immediately Operable Elderly Patient (CALHYS)

NCT05664893

Phase 1/2 Withdrawn Centre Antoine Lacassagne
NaSequentialOpen-labelTreatment

Summary

Women aged 70 years or older, newly diagnosed for locally advanced unilateral breast cancer, with a histological diagnosis of invasive mammary carcinoma, positive hormone receptors, HER2 status Negative, not immediately operable (stage of disease, comorbidities or refusal of surgery) with tumor in place, with indication of treatment with hormone therapy and hypofractionated radiotherapy, not eligible for neoadjuvant chemotherapy and without major comorbidity contraindicating the proposed treatment regimen.

Timeline

Start
2023-06-26
Primary completion
2026-03-26
Completion
2026-03-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Ribociclib Small molecule 200 mg Oral
Subject Ribociclib Small molecule 400 mg Oral
Subject Ribociclib Small molecule 600 mg Oral