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)
- Conditions
- HER2 Negative Breast Cancer Not Immediately Operated
- Interventions
- Registration Number
- NCT05664893
- Lead Sponsor
- Centre Antoine Lacassagne
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 85
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Principal arm Ribociclib Oral Tablet registration phase : 3 cycles of 600mg per day of ribociclib Treatment phase : 3 cycles of dose de-escalation of ribociclib (600 or 400 or 200mg per day) Maintenance phase : 600mg per day of ribociclib until 24months of total treatment
- Primary Outcome Measures
Name Time Method Phase I : determination of Maximal Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D) of Ribociclib Phase I : during the 8 weeks of radiotherapy concomitant with the Ribociclib and hormone therapy and during the 3 months of post-radiotherapy follow-up. Phase I : the frequencies of adverse events according to the CTCAE 4.03 requiring a dose discontinuation (DLT) will be determined during the 8 weeks of radiotherapy concomitant with the Ribociclib and hormone therapy and during the 3 months of post-radiotherapy follow-up.
Phase II : evaluation of the efficacy of Ribociclib in association with hormone therapy and hypofractionated radiotherapy Phase II : at 24-months Phase II :The primary endpoint will be the rate of non-progression at 24-months, defined as the percentage of patients who are alive and have not progressed 24 months after the completion of the Ribociclib and Radiotherapy concomitant phase.
- Secondary Outcome Measures
Name Time Method overall survival 60 months Evaluate overall survival (OS)
progression free survival 60 months Evaluate progression free survival (PFS)
quality of Life (European Organisation for Research and Treatment of Cancer quality of life questionnaire C30) 60 months Evaluate quality of Life (items values from 1 to 4 per question)
quality of Life (ELDERLY CANCER PATIENTS14) 60 months Evaluate quality of Life (items values from 1 to 4 per question)
compliance to Ribociclib 24 months The treatment compliance will be assessed with the 8-item Morisky Medication Adherence Scale (score from 0 to 8)
medical health status 60 months Evaluate the medical health status of the patients with the questionnaire G8, clinical score and visual analog scale for pain severity measurement (score from 0 to 17)
psychosocial health status 60 months Evaluate the psychosocial status of the patients with GDS 4 questionnaire (score from 0 to 4)
functional health status 60 months Evaluate the functional status of the patients with Handgrip strength evaluation
overall tolerance of ribociclib using V5.0 Common Terminology Criteria for Adverse Events scale 25 months The overall tolerance of Ribociclib during ribociclib monotherapy treatment and concomitant ribociclib radiotherapy treatment will be evaluated using clinical and biological assessment and graded according to the V5.0 scale.
Trial Locations
- Locations (1)
Centre Antoine Lacassagne
🇫🇷Nice, France