The RibOB study is a prospective, open lable, single arm trial which will evaluate the clinical efficacy, overall safety and tolerability of ribociclib in combination with letrozole in older women (≥70 years) with HR+/HER2- aBC and no prior hormonal treatment for advanced disease (as per approved indication).
The RibOB study is an observational prospective, open lable single arm phase IV trial which will evaluate the clinical efficacy, overall safety and tolerability of ribociclib in combination with letrozole in older women (≥70 years) with HR+, HER2- advanced breast cancer and no prior hormonal treatment for advanced disease as per the indication approved by the European Medicines Authority (EMA) and as made available by Belgian national authorities in the national health care system. A total of maximum 150 patients will be enrolled for treatment with Letrozole (2.5 mg once daily) + ribociclib 600 mg (day 1 to 21 in a 28 day cycle), which will continue until disease progression, intolerable toxicity or patient/physician decision to withdraw. During the study, patients will be continuously evaluated for disease progression as per national standard of care (approximately every 12 weeks radiologically); for safety; and for quality of life and geriatric assessment components including functional status with QoL assessment and CGA at 3 months (+/- 2 weeks) and at 1 year (+/-2 weeks).
Study Type
OBSERVATIONAL
Enrollment
78
combination of ribociclib and letrozole
UZ Gasthuisberg Leuven
Leuven, Belgium
Progression-free survival (PFS)
Clinical efficacy: Progression-free survival (PFS) (defined as the length of time from the start of treatment and death or progression of disease) as determined by the local investigator using RECIST 1.1 rules.
Time frame: 2018-2022
Time to treatment failure (TTF)
Efficacy: Time to treatment failure (TTF). It is defined as time from date of start of treatment to the date of event defined as the first documented progression, death due to any cause or withdrawal from treatment.
Time frame: 2018-2022
Overall response rate (ORR)
Efficacy: Overall response rate (ORR), for patients with measurable disease as determined locally by investigator according to RECIST 1.1. It is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1.
Time frame: 2018-2022
Overall Survival (OS)
Efficacy: Overall survival (OS). It is defined as the length of time from the start of treatment and death from any cause.
Time frame: 2018-2022
Breast cancer specific survival (BCSS)
Efficacy: Breast cancer specific survival (BCSS). It is defined as the length of time from the start of treatment and death from breast cancer.
Time frame: 2018-2022
Adverse events
Safety: Incidence of Adverse Events according to the NCI-CTCAE 4.03 during study treatment and according to the results of baseline CGA evaluation; Number of patients who stop ribociclib before progression ; number of patients needing dose interruption/reduction.
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Time frame: 2018-2022
Treatment discontinuation
Safety: Number of patients who stop ribociclib before progression
Time frame: 2018-2022
Treatment interruption
Safety: number of patients needing dose interruption
Time frame: 2018-2022
Treatment reduction
Safety: number of patients needing dose reduction
Time frame: 2018-2022
PFS / OS
Prediction Modeling I: PFS and OS prognostic model based on clinical/pathologic characteristics
Time frame: 2018-2022
CGA / QoL
Prediction Modeling II: Baseline CGA and QoL and relation with PFS/OS
Time frame: 2018-2022
Quality of Life (1)
Evolution of QoL during study treatment: EORTC QLQ-C30 (modified) and EORTC IL15 questionnaires
Time frame: 2018-2022
Quality of Life (2)
Correlation of baseline QoL with OS
Time frame: 2018-2022
Quality of Life (3)
Correlation of baseline QoL with toxicity grade III-IV
Time frame: 2018-2022
Comprehensive Geriatric Assessment
Evolution of CGA during study treatment
Time frame: 2018-2022
Plasma Biomarker Research (1)
Evolution of potential aging biomarkers during study treatment, and predictive value of baseline aging biomarkers on toxicity, PFS and OS (correcting for the prognostic metastatic index in PFS / OS)
Time frame: 2018-2022
Plasma Biomarker Research (2)
Predictive capacity of thymidine kinase on toxicity, PFS, OS and RR (correcting for the prognostic metastatic index in PFS, OS and RR). Thymidine kinase d1 versus d15 drop, and Thymidine kinase d15 level
Time frame: 2018-2022
Plasma Biomarker Research (3)
Develop a plasma microRNA signature for response to study treatment (pre-dose cycle 3)
Time frame: 2018-2022
Plasma Biomarker Research (4)
Evaluation of plasma antitumor immunity induction by study treatment at day 15 of cycle 1.
Time frame: 2018-2022