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SLNB After Neoadjuvant Treatment in Node Positive Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03833960
Recruitment Status : Completed
First Posted : February 7, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Ana Car Peterko, Clinical Hospital Center Rijeka

Study Description
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Brief Summary:

From May 2016 till May 2018 all breast cancer patients with operable disease submitted to surgery after neoadjuvant treatment would be divided in four groups considering initially clinical axillary stage, axillary procedure that was done, axillary response to preoperative systemic treatment and pathological axillary stage.

In first postoperative year all patients will be monitored for appearance of locoregional and distant recurrence.


Condition or disease
Sentinel Lymph Node Biopsy Locoregional Neoplasm Recurrence Progression, Disease

Detailed Description:

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.

Study Design
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Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Sentinel Lymph Node Biopsy After Neoadjuvant Treatment on Locoregional Control of Disease in Initially Node Positive Breast Cancer Patients
Actual Study Start Date : May 2016
Actual Primary Completion Date : May 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
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Group/Cohort
1-cN0/pN0
Patients with initially clinically negative axilla (cN0), submitted to neoadjuvant treatment, followed by surgical procedure within ALND or SLNB was done, and the final pathological report was ypN0.
2-cN+/pN0
Patients with initially clinically involved axilla (cN1-2), submitted to neoadjuvant treatment, followed by surgical procedure within ALND or SLNB was done, and the final pathological report was complete axillary remission (ypN0).
3-cN0/pN+
Patients with initially clinically negative axilla (cN0), submitted to neoadjuvant treatment, followed by surgical procedure within SLNB was done, followed by ALND because of positive pathological report of sentinel node(s).
4-cN+/pN+
Patients with initially clinically positive axilla (cN1-3) submitted to neoadjuvant treatment, followed by surgical procedure within ALND was done and the final pathological report was ypN1-3.


Outcome Measures
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Primary Outcome Measures :
  1. Regional recurrence [ Time Frame: 3 years ]
    All patients would be monitored in postoperative period of minimally one year for the appearance of locoregional recurrence. Results will be compared among all node negative patients (group 1 and 2) submitted to SLNB vs. ALND, and among group 2 patients only (ALND vs. SLNB).

  2. Distant recurrence (progression) [ Time Frame: 3 years ]
    All patients would be monitored in postoperative period of minimally one year for appearance of distant recurrence (disease progression). Results will be compared among patients from groups 2 and 4 and among group 2 patients only (ALND vs SLNB).


Other Outcome Measures:
  1. Postoperative complications [ Time Frame: 3 years ]
    To compare prolonged axillary serous secretion and arm lymphedema among patients submitted to ALND and SLNB.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Probability Sample
Study Population
Groups are formed from breast cancer patients with operable disease and involved axillary nodes, submitted to preoperative systemic treatment followed by surgical procedure in CHC Rijeka in period from May 2016 till May 2018
Criteria

Inclusion Criteria:

  • operable breast cancer submitted to neoadjuvant treatment in CHC Rijeka, followed by surgery in period from May 2016 till May 2018

Exclusion Criteria:

  • T4 stage
  • inflammatory breast cancer
  • M1 stage at the time of diagnose
  • bilateral disease
  • multicentric disease
  • unavailable complete required data
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Ana Car Peterko, general surgeon, Clinical Hospital Center Rijeka
ClinicalTrials.gov Identifier: NCT03833960    
Other Study ID Numbers: SLNBvsALND
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ana Car Peterko, Clinical Hospital Center Rijeka:
breast cancer
Sentinel Lymph Node Biopsy
Neoadjuvant Chemotherapy
locoregional recurrence
distant recurrence
Additional relevant MeSH terms:
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Neoplasm Recurrence, Local
Disease Progression
Recurrence
Disease Attributes
 Pathologic Processes
Neoplastic Processes
Neoplasms