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出境医 / 临床实验 / A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib in Older Women With Breastcancer (RibOB)
A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib in Older Women With Breastcancer (RibOB)
Study Description
Brief Summary:
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).
| Condition or disease | Intervention/treatment |
|---|---|
| Breast Cancer | Drug: Ribociclib |
Detailed Description:
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 Design
| Study Type : | Observational |
| Estimated Enrollment : | 150 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib With Letrozole in Older Women (≥70 Years) With HR+ and HER2- Advanced Breast Cancer (aBC) With no Prior Systemic Therapy for Advanced Disease. |
| Actual Study Start Date : | December 11, 2018 |
| Estimated Primary Completion Date : | December 2022 |
| Estimated Study Completion Date : | December 2022 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Progression-free survival (PFS) [ Time Frame: 2018-2022 ]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.
Secondary Outcome Measures :
- Time to treatment failure (TTF) [ Time Frame: 2018-2022 ]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.
- Overall response rate (ORR) [ Time Frame: 2018-2022 ]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.
- Overall Survival (OS) [ Time Frame: 2018-2022 ]Efficacy: Overall survival (OS). It is defined as the length of time from the start of treatment and death from any cause.
- Breast cancer specific survival (BCSS) [ Time Frame: 2018-2022 ]Efficacy: Breast cancer specific survival (BCSS). It is defined as the length of time from the start of treatment and death from breast cancer.
- Adverse events [ Time Frame: 2018-2022 ]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.
- Treatment discontinuation [ Time Frame: 2018-2022 ]Safety: Number of patients who stop ribociclib before progression
- Treatment interruption [ Time Frame: 2018-2022 ]Safety: number of patients needing dose interruption
- Treatment reduction [ Time Frame: 2018-2022 ]Safety: number of patients needing dose reduction
- PFS / OS [ Time Frame: 2018-2022 ]Prediction Modeling I: PFS and OS prognostic model based on clinical/pathologic characteristics
- CGA / QoL [ Time Frame: 2018-2022 ]Prediction Modeling II: Baseline CGA and QoL and relation with PFS/OS
- Quality of Life (1) [ Time Frame: 2018-2022 ]Evolution of QoL during study treatment: EORTC QLQ-C30 (modified) and EORTC IL15 questionnaires
- Quality of Life (2) [ Time Frame: 2018-2022 ]Correlation of baseline QoL with OS
- Quality of Life (3) [ Time Frame: 2018-2022 ]Correlation of baseline QoL with toxicity grade III-IV
- Comprehensive Geriatric Assessment [ Time Frame: 2018-2022 ]Evolution of CGA during study treatment
- Plasma Biomarker Research (1) [ Time Frame: 2018-2022 ]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)
- Plasma Biomarker Research (2) [ Time Frame: 2018-2022 ]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
- Plasma Biomarker Research (3) [ Time Frame: 2018-2022 ]Develop a plasma microRNA signature for response to study treatment (pre-dose cycle 3)
- Plasma Biomarker Research (4) [ Time Frame: 2018-2022 ]Evaluation of plasma antitumor immunity induction by study treatment at day 15 of cycle 1.
Biospecimen Retention: Samples With DNA
Blood samples will be collected at T0 (i.e. at the time of inclusion of the patient), at T1 (i.e. at day 15 of the first treatment cycle) and at T2 (after 3 months) and in addition to routine laboratory exams, blood drawn will be processed and frozen for future translational research exploring biological aging markers (as predictive markers of functional decline and survival) and biomarkers of response prediction. The central biobanking laboratory in Leuven will provide complete blood sampling sets per patient, containing 3 subsets (one for each time point) with all blood tubes, pre-printed labels and serum/plasma aliquot vials required at that time point, as well as disposable Pasteur pipettes for serum/plasma transfer.
Eligibility Criteria
Contacts and Locations
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 12, 2019 | ||||
| First Posted Date | May 21, 2019 | ||||
| Last Update Posted Date | March 18, 2021 | ||||
| Actual Study Start Date | December 11, 2018 | ||||
| Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Progression-free survival (PFS) [ Time Frame: 2018-2022 ] 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.
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| Original Primary Outcome Measures |
Progression-free survival (PFS) [ Time Frame: 2018-2022 ] 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
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| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib in Older Women With Breastcancer | ||||
| Official Title | A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib With Letrozole in Older Women (≥70 Years) With HR+ and HER2- Advanced Breast Cancer (aBC) With no Prior Systemic Therapy for Advanced Disease. | ||||
| Brief Summary | 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). | ||||
| Detailed Description | 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 | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description:
Blood samples will be collected at T0 (i.e. at the time of inclusion of the patient), at T1 (i.e. at day 15 of the first treatment cycle) and at T2 (after 3 months) and in addition to routine laboratory exams, blood drawn will be processed and frozen for future translational research exploring biological aging markers (as predictive markers of functional decline and survival) and biomarkers of response prediction. The central biobanking laboratory in Leuven will provide complete blood sampling sets per patient, containing 3 subsets (one for each time point) with all blood tubes, pre-printed labels and serum/plasma aliquot vials required at that time point, as well as disposable Pasteur pipettes for serum/plasma transfer.
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| Sampling Method | Probability Sample | ||||
| Study Population | This study will include older women (defined as ≥70 years) with HR+, HER2- advanced breast cancer who had not received any prior hormonal agent for treatment of advanced disease. It is expected that at least 50% of patients will be older than 75 years. | ||||
| Condition | Breast Cancer | ||||
| Intervention | Drug: Ribociclib
combination of ribociclib and letrozole
Other Name: Kisqali
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
150 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 2022 | ||||
| Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 70 Years and older (Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | Belgium | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03956654 | ||||
| Other Study ID Numbers | s61033 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | prof. dr. Hans Wildiers, Universitaire Ziekenhuizen Leuven | ||||
| Study Sponsor | Universitaire Ziekenhuizen Leuven | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Universitaire Ziekenhuizen Leuven | ||||
| Verification Date | March 2021 | ||||
