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NCT03944434: FACILE
FACILE: FeAsibility of First-line RiboCIclib in OLdEr Patients with Advanced Breast Cancer
Phase 2 trial testing Ribociclib in Breast Cancer in 116 participants. Participants enrolled and being followed up; not accepting new ones.
27 December 2024
Quick facts
| Lead sponsor | Fondazione Sandro Pitigliani |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 116 |
| Start date | 27 December 2018 |
| Primary completion | 27 December 2024 |
| Estimated completion | 27 November 2025 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Ribociclib (ribociclib) — full drug profile →
- Aromatase Inhibitors, non steroideal — full drug profile →
- LHRH agonist (lhrh-agonist) — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Fondazione Sandro Pitigliani — full company profile →
Who can join
70 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Phase II, multicenter, single arm trial to assess the feasibility of first line ribociclib in combination with a non steroidal aromatase inhibitor in women or men aged 70 years-old or older, with hormone receptor positive/HER2 negative advanced breast cancer
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
CDK4 and CDK6 kinases: From basic science to cancer therapy.
Fassl A, Geng Y, Sicinski P. · · 2022 · cited 351× · PMID 35025636 · DOI 10.1126/science.abc1495 -
Combination Therapy and Nanoparticulate Systems: Smart Approaches for the Effective Treatment of Breast Cancer.
Gadag S, Sinha S, Nayak Y, Garg S, et al · · 2020 · cited 25× · PMID 32521684 · DOI 10.3390/pharmaceutics12060524 -
Targeting CDK4/6 in breast cancer.
Shanabag A, Armand J, Son E, Yang HW. · · 2025 · cited 21× · PMID 39930131 · DOI 10.1038/s12276-025-01395-3 -
Breast Cancer: Molecular Pathogenesis and Targeted Therapy.
Samad MA, Ahmad I, Khan MR, Suhail M, et al · · 2025 · cited 1× · PMID 41049266 · DOI 10.1002/mco2.70404 -
Efficacy and Predictability of Cyclin-Dependent Kinase 4/6 Inhibitors in HER2-Positive Breast Cancer.
Abbasi MS, Afzal MZ, Sarwar T, Gamlen-Steves HA. · · 2025 · cited 1× · PMID 40940886 · DOI 10.3390/cancers17172788 -
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
Verify or expand the search:
- PubMed search for NCT03944434
- 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 Fondazione Sandro Pitigliani trials
Trials by the same sponsor.
- NCT04660435 — To Identify Primary Resistance to CDK4/6 Inhibitors in Breast Cancer · recruiting
- NCT06363812 — Probability of OncotypeDx to Reallocate As Low or High Risk of Recurrence Breast Cancer Patients with Uncertain Biology · completed
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 NCT03944434 (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 Fondazione Sandro Pitigliani
- Last refreshed: 26 February 2025
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/NCT03944434.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing