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NCT06311383: RIBANNA
A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Ribociclib + AI/FUL, or With Endocrine Therapy or Chemotherapy as First Line Treatment
trial testing First-line Ribociclib + endocrine therapy in Breast Cancer in 2,610 participants. Completed in 10 March 2025.
10 March 2025
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 2,610 |
| Start date | 9 October 2017 |
| Primary completion | 10 March 2025 |
| Estimated completion | 10 March 2025 |
| Sites | 265 locations across Germany |
Drugs / interventions tested
- First-line Ribociclib + endocrine therapy — full drug profile →
- First-line endocrine therapy — full drug profile →
- First-line chemtherapy — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
Adults 18 to 100, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a non-interventional observational study conducted in Germany to evaluate the real-world effectiveness, tolerability, safety, and quality of life in patients with locally advanced/metastatic HR+/HER2- breast cancer treated with one of the following 1st line treatments: Ribociclib + AI/FUL, or endocrine monotherapy, or chemotherapy
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Conditional progression-free survival in patients with metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer treated with first-line ribociclib and endocrine therapy: real-world data from the RIBANNA study.
Decker T, Brucker C, Engel A, Fasching PA, et al · · 2025 · cited 1× · PMID 40381382 · DOI 10.1016/j.esmoop.2025.105105 -
Real-world progression-free survival and overall survival in patients with HR<sup>+</sup>/HER2<sup>-</sup> advanced breast cancer treated in first-line with ribociclib, endocrine monotherapy or chemotherapy: Results from the observational RIBANNA study.
Fasching PA, Brucker C, Decker T, Engel A, et al · · 2026 · PMID 41792052 · DOI 10.1002/ijc.70397
Verify or expand the search:
- PubMed search for NCT06311383
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
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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 NCT06311383 (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 Novartis Pharmaceuticals
- Last refreshed: 27 January 2026
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/NCT06311383.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing