Trial · NCT05664893
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 | overall survival | 24 months | Evaluate overall survival (OS) |
| Secondary | overall survival | 60 months | Evaluate overall survival (OS) |
| Secondary | progression free survival | 24 months | Evaluate progression free survival (PFS) |
| Secondary | progression free survival | 60 months | Evaluate progression free survival (PFS) |
| Secondary | 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) |
| Secondary | quality of Life (ELDERLY CANCER PATIENTS14) | 60 months | Evaluate quality of Life (items values from 1 to 4 per question) |
| Secondary | compliance to Ribociclib | 24 months | The treatment compliance will be assessed with the 8-item Morisky Medication Adherence Scale (score from 0 to 8) |
| Secondary | 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) |
| Secondary | psychosocial health status | 60 months | Evaluate the psychosocial status of the patients with GDS 4 questionnaire (score from 0 to 4) |
| Secondary | functional health status | 60 months | Evaluate the functional status of the patients with the questionnaires MINI MENTAL STATE EXAMINATION (score from 0 to 30) |
| Secondary | functional health status | 60 months | Evaluate the functional status of the patients with the questionnaires Autonomy Daily Living (score from 0 to 6) |
| Secondary | functional health status | 60 months | Evaluate the functional status of the patients with the questionnaires (Instrumental Activities in Daily Living (score from 0 to 8) |
| Secondary | functional health status | 60 months | Evaluate the functional status of the patients with the questionnaires walking speed |
| Secondary | functional health status | 60 months | Evaluate the functional status of the patients with the questionnaires percentage of weight loss |
| Secondary | functional health status | 60 months | Evaluate the functional status of the patients with Handgrip strength evaluation |
| Secondary | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT05664893/registered