CompletedNCT03956654RibOBUpdated Aug 9, 2024

A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib in Older Women With Breastcancer

An observational study in Breast Cancer, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to female participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2024-08-09.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 78
Ages: 70 Years and older
Sex: Female

Study 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).

Read the 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).

Conditions studied

Breast Cancer

Browse trials for

Breast Neoplasms 12,820

Keywords

breast cancer
elderly
geriatric assessment
geriatric oncology
translational research
biomarkers

In context

Breast Neoplasms

12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's enrollment of 78 is below the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 959 studies on the registry; 263 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Universitaire Ziekenhuizen KU Leuven studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 70 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patient is a female ≥ 70 years old at the time of informed consent.
Advanced breast cancer (defined as locoregionally recurrent or metastatic not amenable to curative therapy).
Histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory (defined as ER and/or PgR ≥1% or Allred >2).
HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test as determined by local laboratory testing according to ASCO-CAP guidelines is necessary.
Patient has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by local laboratory), preferably tested a maximum of 14 days before enrolment:
Patient has signed informed consent obtained before any trial-related activities and according to local guidelines.
Subjects must be able to communicate with the investigator and comply with the requirements of the study procedures.

Exclusion criteria

Exclusion Criteria:

Patient has a known hypersensitivity to any of the excipients of ribociclib or letrozole.
Patients who received any CDK4/6 inhibitor previously.
Patient who received any prior systemic antihormonal therapy or chemotherapy for advanced breast cancer.
Patient is concurrently using other systemic anti-cancer therapy (except bone modifying agents).
Patient with central nervous system (CNS) metastases and/or documented meningeal carcinomatosis unless they meet ALL the following criteria:
At least 4 weeks from prior therapy for CNS disease completion (including radiation and/or surgery) to starting the study treatment;
Clinically stable CNS lesions at the time of study treatment initiation and not receiving steroids and/or enzyme-inducing anti-epileptic medications for the management of brain metastases for at least 2 weeks (radiological confirmation of brain disease status is not necessary).
Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol: (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.).
Patients who already have or who are at significant risk of developing QTc prolongation are not eligible for the study. This includes patients:
with long QT syndrome;
with uncontrolled or significant cardiac disease, including recent myocardial infarction, congestive heart failure, unstable angina and bradyarrhythmias;
with electrolyte abnormalities (potassium, magnesium, sodium and calcium) that are NCI CTCAE 4.03 grade 2 or higher (for details, see table 10 ). Note: phosphate testing is not mandatory, but should the investigator consider measuring it before enrolment, the same rules may be applied

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 78 participants (actual)
Patient registry: No
Biospecimen retention: Samples with dna

Interventions

DrugRibociclib
combination of ribociclib and letrozole
Also known as: Kisqali

What researchers measure

Primary outcomes

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

Secondary outcomes

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.
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

Study locations

1 site

UZ Gasthuisberg Leuven
Leuven, B-3000, Belgium

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2018 to primary completion in May 2022, 41 months.

Of 1,012 non-industry observational studies under Breast Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 141. This study's 41 months is below that.

Counting every sponsor, half of 1,165 studies reached it within 58 months; a quarter within 26 and three quarters within 125.

How these figures are worked out, and which studies are left out of them.

Registered: Apr 12, 2019
First posted: May 21, 2019
StartActual: Dec 11, 2018
Primary completionActual: May 31, 2022
CompletionActual: Jun 30, 2024
Last update: Aug 9, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03956654
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Responsible party: prof. dr. Hans Wildiers (adjunct head of clinic, Universitaire Ziekenhuizen KU Leuven) — Principal investigator
First posted: May 21, 2019
Start date: Dec 11, 2018
Primary completion: May 31, 2022
Completion: Jun 30, 2024
Last update: Aug 9, 2024

Study contacts

Hans Wildiers, prof. dr.

study chair · UZ Gasthuisberg

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Breast Neoplasms →

Other studies from this sponsor

Universitaire Ziekenhuizen KU Leuven →

Start the discussion