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)

Phase I/II 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 (or Wishing to Avoid Surgery), Elderly Patient (CALHYS)

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Centre Antoine Lacassagne · Academic / Other
• Sex: Female
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HER2 Negative Breast Cancer Not Immediately Operated

Interventions

Type	Name	Description
DRUG	Ribociclib Oral Tablet	600mg per day during registration phase (3 cycles); de-escalation phase (600 to 200mg per day associated to radiotherapy) during 3 other cycles; maintenance phase until 24 months of treatment in total (600mg per day). All over th etimme, hormonotherapy is received in concomitance

Timeline

• Start date: 2023-06-26
• Primary completion: 2026-03-26
• Completion: 2026-03-26
• First posted: 2022-12-27
• Last updated: 2026-04-15

Locations

1 site across 1 country: France