deltatrials
Completed OBSERVATIONAL NCT03833960

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

Updated 7 times since 2019 Last updated: Dec 17, 2023 Started: May 31, 2016 Primary completion: May 31, 2019 Completion: Jun 30, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Mar 2019 – ~Jul 2019 · 4 months · monthly snapshotActive Not Recruiting~Jul 2019 – ~Jan 2021 · 18 months · monthly snapshotCompleted~Jan 2021 – ~Jan 2024 · 36 months · monthly snapshotCompleted~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed

  2. Sep 2024 — Present [monthly]

    Completed

  3. Jul 2024 — Sep 2024 [monthly]

    Completed

  4. Jan 2024 — Jul 2024 [monthly]

    Completed

  5. Jan 2021 — Jan 2024 [monthly]

    Completed

Show 2 earlier versions
  1. Jul 2019 — Jan 2021 [monthly]

    Completed

    Status: Active Not RecruitingCompleted

  2. 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

Sponsor contact:
  • Clinical Hospital Center Rijeka
Data source: Clinical Hospital Center Rijeka

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.