Last reviewed · How we verify
NCT03956654: RibOB
A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib in Older Women With Breastcancer
trial testing Ribociclib in Breast Cancer in 78 participants. Completed in 30 June 2024.
31 May 2022
Quick facts
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 78 |
| Start date | 11 December 2018 |
| Primary completion | 31 May 2022 |
| Estimated completion | 30 June 2024 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Ribociclib (ribociclib) — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Universitaire Ziekenhuizen KU Leuven — full company profile →
Who can join
70 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
The evolution of cyclin dependent kinase inhibitors in the treatment of cancer.
Jhaveri K, Burris Rd HA, Yap TA, Hamilton E, et al · · 2021 · cited 40× · PMID 34176404 · DOI 10.1080/14737140.2021.1944109 -
Key Considerations for the Treatment of Advanced Breast Cancer in Older Adults: An Expert Consensus of the Canadian Treatment Landscape.
Jackson EB, Curry L, Mariano C, Hsu T, et al · · 2023 · cited 1× · PMID 38248095 · DOI 10.3390/curroncol31010010 -
A phase IV prospective study of efficacy and safety of ribociclib and letrozole as first-line therapy in older women (≥70 years) with hormone receptor-positive HER2-negative advanced breast cancer: the RibOB study.
Van Houdt M, Kenis C, De Nys L, Hatse S, et al · · 2026 · PMID 41512682 · DOI 10.1016/j.esmoop.2025.105896
Verify or expand the search:
- PubMed search for NCT03956654
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ribociclib
Trials testing the same drug.
- NCT07492641 — BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer · Phase 3 · not yet recruiting
- NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
- NCT06905301 — Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and W · recruiting
- NCT06930859 — Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Recepto · recruiting
- NCT07054190 — A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer · Phase 2 · recruiting
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
- NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
- NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
- NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
- NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
- NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
Other Universitaire Ziekenhuizen KU Leuven trials
Trials by the same sponsor.
- NCT06831955 — LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Therapy in Patients With Triple Negative Breast Cancer · Phase 2 · recruiting
- NCT07356505 — Efficacy and Safety of Micra AV2 Transcatheter Pacing System · NA · recruiting
- NCT07286968 — Gastro-Intestinal Digestion and Physiology After Bariatric Surgery · recruiting
- NCT06962137 — Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer · Phase 2 · recruiting
- NCT07270536 — Accelerated Pacing and Cardiac Filling Pressures During Exercise in Patients With Heart Failure With Preserved Ejection · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03956654 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universitaire Ziekenhuizen KU Leuven
- Last refreshed: 9 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03956654.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing