Last reviewed · How we verify
NCT03463681: BREAKPOINT
A Study of CaBozantinib in Patients With Advanced or Unresectable Renal cEll cArcinoma
Phase 2 trial testing Cabometyx in Metastatic Renal Cell Carcinoma in 49 participants. Completed in 8 April 2021.
8 April 2021
Quick facts
| Lead sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 49 |
| Start date | 11 June 2018 |
| Primary completion | 8 April 2021 |
| Estimated completion | 8 April 2021 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Cabometyx (Cabometyx) — full drug profile →
Conditions studied
- Metastatic Renal Cell Carcinoma — all drugs for Metastatic Renal Cell Carcinoma →
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano — full company profile →
Who can join
Adults 18 to 85, any sex, with Metastatic Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open label single arm, multicenter, phase II study designet To assess the progression free survival (PFS) of cabozantinib in patients pretreated with one immunocheckpoint inhibitor (CPI) in monotherapy or in combination
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Endothelial cells in tumor microenvironment: insights and perspectives.
Leone P, Malerba E, Susca N, Favoino E, et al · · 2024 · cited 90× · PMID 38426109 · DOI 10.3389/fimmu.2024.1367875 -
A multicenter phase 2 single arm study of cabozantinib in patients with advanced or unresectable renal cell carcinoma pre-treated with one immune-checkpoint inhibitor: The BREAKPOINT trial (Meet-Uro trial 03).
Procopio G, Claps M, Pircher C, Porcu L, et al · · 2023 · cited 40× · PMID 36447337 · DOI 10.1177/03008916221138881 -
Targeting Tyrosine kinases in Renal Cell Carcinoma: "New Bullets against Old Guys".
Alonso-Gordoa T, García-Bermejo ML, Grande E, Garrido P, et al · · 2019 · cited 39× · PMID 30999623 · DOI 10.3390/ijms20081901 -
Efficacy and safety of FLT3 inhibitors in monotherapy of hematological and solid malignancies: a systemic analysis of clinical trials.
Zhao Y, Zhang X, Ding X, Wang Y, et al · · 2024 · cited 7× · PMID 38828446 · DOI 10.3389/fphar.2024.1294668 -
Cabozantinib combination therapy for the treatment of solid tumors: a systematic review.
Castellano D, Apolo AB, Porta C, Capdevila J, et al · · 2022 · cited 6× · PMID 35923927 · DOI 10.1177/17588359221108691 -
VEGF-TKI Outcomes in Metastatic Renal Cell Carcinoma According to Prior Immune Checkpoint Inhibitor or VEGF-TKI: A Scoping Review and Exploratory Analysis
· 2026
Verify or expand the search:
- PubMed search for NCT03463681
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cabometyx
Trials testing the same drug.
- NCT04714697 — Cabozantinib as Subsequent Therapy to an Immune Checkpoint Based Therapy in Renal Cell Carcinoma · Phase 2 · unknown
Other recruiting trials for Metastatic Renal Cell Carcinoma
Currently open trials in the same condition.
- NCT06863311 — Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear C · Phase 2 · recruiting
- NCT07227415 — Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Antica · Phase 1, PHASE2 · recruiting
- NCT07123090 — A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma · Phase 2 · recruiting
- NCT06391099 — Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic · NA · recruiting
- NCT06500455 — Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to · Phase 3 · recruiting
Other Fondazione IRCCS Istituto Nazionale dei Tumori, Milano trials
Trials by the same sponsor.
- NCT06799624 — Prognostic Role of molEcular classiFication in Fertility-sparing treAtment of Endometrial canCEr · not yet recruiting
- NCT07253402 — Microbiota-guided Radiotherapy for Head and Neck Cancer · recruiting
- NCT06938724 — Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer · Phase 2 · recruiting
- NCT06999824 — Revisiting the Concept of Nerve Sparing Radical Hysterectomy · not yet recruiting
- NCT06986486 — Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma · 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 NCT03463681 (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 IRCCS Istituto Nazionale dei Tumori, Milano
- Last refreshed: 26 April 2021
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/NCT03463681.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing