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

NCT03956654 | Completed FDA Drug

• 1 other identifier: s61033
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Keywords

breast cancer; elderly; geriatric assessment; geriatric oncology; translational research; biomarkers

Outcome Measures

Primary Outcomes (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.

  2018-2022

Secondary Outcomes (18)

• Time to treatment failure (TTF)

  2018-2022

• Overall response rate (ORR)

  2018-2022

• Overall Survival (OS)

  2018-2022

• Breast cancer specific survival (BCSS)

  2018-2022

• Adverse events

  2018-2022

Interventions

Ribociclib DRUG

combination of ribociclib and letrozole

Also known as: Kisqali

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Gasthuisberg Leuven

Leuven, B-3000, Belgium

Location

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.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ribociclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hans Wildiers, prof. dr.

  UZ Gasthuisberg

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: adjunct head of clinic

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: May 21, 2019
• Study Start: December 11, 2018
• Primary Completion: May 31, 2022
• Study Completion: June 30, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

BE (1)