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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NCT05664893 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2026-04-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Centre Antoine Lacassagne

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05664893 on ClinicalTrials.gov