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Breast CancerRibOBNCT03956654

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

An observational study of Breast Cancer, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 70 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Ribociclib
How many people
78 participants
Where
1 siteBelgium
Study dates
11 Dec 2018to 30 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • Women only
  • No healthy volunteers
  • Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • UZ Gasthuisberg Leuven

    Leuven, B-3000

Other trials in Belgium

About this study

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.

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
Breast Cancer
Being tested
Ribociclib
Keywords
breast cancer, elderly, geriatric assessment, geriatric oncology, translational research, biomarkers
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RibociclibDrug

    Also called Kisqali

    combination of ribociclib and letrozole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2018-2022

Secondary outcomes (18)

  1. 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.

    Measured: 2018-2022

  2. 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.

    Measured: 2018-2022

  3. 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.

    Measured: 2018-2022

  4. 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.

    Measured: 2018-2022

  5. 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.

    Measured: 2018-2022

  6. Treatment discontinuation

    Safety: Number of patients who stop ribociclib before progression

    Measured: 2018-2022

  7. Treatment interruption

    Safety: number of patients needing dose interruption

    Measured: 2018-2022

  8. Treatment reduction

    Safety: number of patients needing dose reduction

    Measured: 2018-2022

  9. PFS / OS

    Prediction Modeling I: PFS and OS prognostic model based on clinical/pathologic characteristics

    Measured: 2018-2022

  10. CGA / QoL

    Prediction Modeling II: Baseline CGA and QoL and relation with PFS/OS

    Measured: 2018-2022

  11. Quality of Life (1)

    Evolution of QoL during study treatment: EORTC QLQ-C30 (modified) and EORTC IL15 questionnaires

    Measured: 2018-2022

  12. Quality of Life (2)

    Correlation of baseline QoL with OS

    Measured: 2018-2022

  13. Quality of Life (3)

    Correlation of baseline QoL with toxicity grade III-IV

    Measured: 2018-2022

  14. Comprehensive Geriatric Assessment

    Evolution of CGA during study treatment

    Measured: 2018-2022

  15. 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)

    Measured: 2018-2022

  16. 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

    Measured: 2018-2022

  17. Plasma Biomarker Research (3)

    Develop a plasma microRNA signature for response to study treatment (pre-dose cycle 3)

    Measured: 2018-2022

  18. Plasma Biomarker Research (4)

    Evaluation of plasma antitumor immunity induction by study treatment at day 15 of cycle 1.

    Measured: 2018-2022

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2019
  2. Study start11 Dec 2018
  3. Primary completion31 May 2022
  4. Study completion30 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03956654
Sponsor's protocol ID
s61033
Acronym
RibOB
Status last verified
Aug 2024
First submitted
12 Apr 2019
Last updated
9 Aug 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: 2018-2022). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03956654.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.

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RibOB Clinical Trial NCT03956654 | AzTrials