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NCT03719833
Sentinel Lymph Node Biopsy After Neoadjuvant Treatment in Breast Cancer Patents
trial in Breast Cancer in 230 participants. Completed in 28 July 2025.
28 July 2025
Quick facts
| Lead sponsor | Clinical Hospital Center Rijeka |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 230 |
| Start date | 21 September 2018 |
| Primary completion | 28 July 2025 |
| Estimated completion | 28 July 2025 |
| Sites | 1 location across Croatia |
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Sentinel Lymph Node Biopsy — all drugs for Sentinel Lymph Node Biopsy →
- Neoadjuvant Chemotherapy — all drugs for Neoadjuvant Chemotherapy →
Sponsor
Clinical Hospital Center Rijeka
Who can join
Adults 18 to 80, female only, with Breast Cancer or Sentinel Lymph Node Biopsy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This clinical trial is designed as an observational study of 8-9 years of overall duration, but the first results and conclusions could be achieved in 3-4 years. In the first phase, which would last 3-4 years, the investigators will form three predetermined groups of breast cancer patients that would be monitored in the second phase for 5 postoperative years. All patients involved in this trial would undergo a defined protocol. All patients participating in this trial and all members of the investigation team would be completely introduced to the plan and aims of this trial. Two main hypotheses of this trial are that SLNB does not have a negative impact on clinical outcomes (locoregional recurrence and overall survival) in initially node-positive patients who achieved complete clinically axillary remission after neoadjuvant systemic treatment and that lymph node status after neoadjuvant treatment is a significantly more relevant prognostic factor than nodal status at the time of diagnosis. Therefore, the aim is to establish that sentinel lymph node biopsy, in node-positive breast cancer patients that achieve clinical remission after neoadjuvant treatment, is a reliable approach for surgical axillary management. Data would be collected individually for each patient and recorded on appropriate forms. After data completion, the principal investigator would import encoded data into the register. Data collected in this trial would be used for publications.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03719833
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Clinical Hospital Center Rijeka 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 NCT03719833 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Clinical Hospital Center Rijeka
- Last refreshed: 30 July 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/NCT03719833.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing