SLNB After Neoadjuvant Treatment in Node Positive Patients
Impact of Sentinel Lymph Node Biopsy After Neoadjuvant Treatment on Locoregional Control of Disease in Initially Node Positive Breast Cancer Patients
Sponsor: Clinical Hospital Center Rijeka
Listed as NCT03833960, this observational or N/A phase trial focuses on Locoregional Neoplasm Recurrence and Progression, Disease and remains completed. Sponsored by Clinical Hospital Center Rijeka, it has been updated 7 times since 2016, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)From May 2017 SLNB after neoadjuvant treatment was introduced in clinical practice for breast cancer patients presenting initially with involved axilla but shifted to clinically negative followed neoadjuvant treatment. This retrospective analysis is designed for period of one year before and one year later to compare the clinical outcomes for this patients in the setting where ALND was performed to the setting where SLNB was performed.
The main hypothesis was to establish that SLNB after neoadjuvant treatment, in initially node positive breast cancer patients that achieve complete clinical remission following neoadjuvant treatment, is reliable alternative to ALND in maintenance of locoregional control of disease.
For the purpose of this trial four groups were created and the results would be compared among them. In first postoperative year patients were monitored for the appearance of locoregional and distant recurrence.
Data were collected individually for each patient and recorded in register. All data are available to all members of investigation team, members of Ethic Committee and statistician.
Data collected in this trial would be used for publication.
From May 2017 SLNB after neoadjuvant treatment was introduced in clinical practice for breast cancer patients presenting initially with involved axilla but shifted to clinically negative followed neoadjuvant treatment. This retrospective analysis is designed for period of one year before and one year later to compare the clinical outcomes for this patients in the setting where ALND was performed to the setting where SLNB was performed.
The main hypothesis was to establish that SLNB after neoadjuvant treatment, in initially node positive breast cancer patients that achieve complete clinical remission following neoadjuvant treatment, is reliable alternative to ALND in maintenance of locoregional control of disease.
For the purpose of this trial four groups were created and the results would be compared among them. In first postoperative year patients were monitored for the appearance of locoregional and distant recurrence.
Data were collected individually for each patient and recorded in register. All data are available to all members of investigation team, members of Ethic Committee and statistician.
Data collected in this trial would be used for publication.
Status Flow
Change History
7 versions recorded-
Jan 2026 — Present [monthly]
Completed
-
Sep 2024 — Present [monthly]
Completed
-
Jul 2024 — Sep 2024 [monthly]
Completed
-
Jan 2024 — Jul 2024 [monthly]
Completed
-
Jan 2021 — Jan 2024 [monthly]
Completed
▶ Show 2 earlier versions
-
Jul 2019 — Jan 2021 [monthly]
Completed
Status: Active Not Recruiting → Completed
-
Mar 2019 — Jul 2019 [monthly]
Active Not Recruiting
First recorded
May 2016
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Clinical Hospital Center Rijeka
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
No location information available.