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Sentinel Lymph Node Biopsy After Neoadjuvant Treatment in Breast Cancer Patents

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: NCT03719833
Recruitment Status : Enrolling by invitation
First Posted : October 25, 2018
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Ana Car Peterko, Clinical Hospital Center Rijeka

Brief Summary:

This clinical trial is designed as observational study of overall duration of 8-9 years, but the first results and conclusions could be achieved in 3-4 years. In the first phase, that 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 defined protocol. All patients participating in this trial and all members of investigation team would be completely introduced to plan and aims of this trial.

Two main hypothesis of this trial are that SLNB does not have 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 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 reliable approach for sugical axillary management.

Data would be collected individually for each patient and recorded on appropriated forms. After data completion, leading investigator would import encoded data in register. Data collected in this trial would be used for publications.


Condition or disease
Breast Cancer Sentinel Lymph Node Biopsy Neoadjuvant Chemotherapy

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Years
Official Title: Sentinel Lymph Node Biopsy After Neoadjuvant Oncological Treatment in Luminal B, HER-2 Positive and Triple Negative Breast Cancer Patients in Stage T1-3 N0-2 M0 at the Time of Diagnose
Actual Study Start Date : September 21, 2018
Estimated Primary Completion Date : May 2027
Estimated Study Completion Date : May 2027

Resource links provided by the National Library of Medicine


Group/Cohort
1-control group-T1-T2 N0 M0

Breast cancer patients in T1 N0 M0 stage at time of diagnose who initial undergo surgical treatment (quadrantectomy/mastectomy + sentinel lymph node biopsy).

All patients will be followed for 5 years after surgery

2-T2-T3 N0 M0

Breast cancer patients in T2-T3 N0 M0 stage at time of diagnose who undergo neoadjuvant oncological treatment followed by surgery (quadrantectomy/mastectomy + sentinel lymph node biopsy). For presence of any residual tumor in lymph node(s) at final pathology report, ALND would be made.

All patients will be followed for 5 years after surgery

3-T1-T3 N1-N2 M0

Breast cancer patients in T1-T3 N1-N2 M0 stage at time of diagnose who undergo neoadjuvant oncological treatment followed by ultrasound reevaluation of axillary lymph nodes that indicate complete clinical axillary remission. Surgical procedure that would be performed is quadrantectomy/mastectomy + sentinel lymph node biopsy.

Before initiating neoadjuvant treatment biopsy (FNA) proven positive node will be marked with titanium clip and at the time of surgery removed and pathological examined regardless presenting as a sentinel node or not.

For presence of any residual tumor in lymph node(s) at final pathology report, ALND would be made All patients will be followed for 5 years after surgery




Primary Outcome Measures :
  1. Impact of sentinel lymph node biopsy procedure on locoregional recurrence for group 3 sentinel node negative patients [ Time Frame: 5 postoperative years ]
    Locoregional recurrence for group 3 sentinel node negative patients compared to group 1 and 2, to our former data and literature data

  2. Correlation of sentinel node negative patients from group 3 patients and overall survival [ Time Frame: 5 postoperative years ]

    Overall survival from sentinel node negative patients from group 3 compared to overall survival from sentinel node positive patients from group 3 and overall survival from patients from group 3 that did not achieve complete clinical axillary remission.

    Overall survival for group 3 sentinel node negative patients compared to group 1 and 2 and to our former data (patients of same stage at diagnosis treated without neoadjuvant systemic therapy)


  3. Correlation of sentinel node negative patients from group 3 and disease progression free survival [ Time Frame: 5 postoperative years ]

    Disease progression free survival from sentinel node negative patients from group 3 compared to disease progression free survival from sentinel node positive patients from group 3 and disease progression free survival from patients from group 3 that did not achieve complete clinical axillary remission.

    Disease progression free survival for group 3 sentinel node negative patients compared to group 1 and 2 and to our former data (patients of same stage at diagnosis treated without neoadjuvant systemic therapy)



Secondary Outcome Measures :
  1. Evaluate if identification and biopsy of pre-neoadjuvant proven positive lymph node increase the reliability of sentinel lymph node biopsy after neoadjuvant treatment in patients that achieve complete clinical remission of axillary lymph nodes [ Time Frame: 3,5 years (recruiting period) ]
    All nodes marked with titanium clip will be evaluated due to presence or absence of signal regardless being positive or negative Correspondence rate between marked node and sentinel node would be calculated Correspondence rate between non-sentinel node and marked node that is positive on final pathology report would be calculated

  2. Evaluate the correlations of axillary response to neoadjuvant treatment and pathological characteristic of tumor [ Time Frame: 3,5 years (recruiting period) ]
    Statistical analysis of treated patients and outcomes of neoadjuvant treatment-analysis of complete pathological axillary remission related to characteristics of primary tumor (type, grade, size, proliferation index and presence of lymphovascular invasion) Evaluate when is nodal disease indication for neoadjuvant treatment regardless the tumor size

  3. Evaluate accuracy of axillary ultrasound after neoadjuvant treatment (overall and related to tumor subtypes) [ Time Frame: 3.5 years ]
    Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of axillary ultrasound after neoadjuvant treatment

  4. Evaluate accuracy of standard breast MR imaging in axillary lymph node evaluation after neoadjuvant treatment (overall and related to tumor subtypes) [ Time Frame: 3.5 years ]
    Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of breast MR imaging in evaluation of axillary lymph nodes after neoadjuvant treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Groups will be formed of the breast cancer patients who meet the eligible criteria treated in Clinical Hospital Centar Rijeka in defined period
Criteria

Inclusion Criteria:

  • Patients must be female
  • Patients must be older then 18 years of age and younger of 80 years of age
  • Patents must have biopsy proven breast cancer, histological type-ductal, immunophenotype-Luminal B, HER-2 positive and triple negative
  • Patients with nodal disease (N1-N2) must have fine needle aspiration proven positive node and marked node with titanium clip before onset of neoadjuvant treatment
  • Patients treated (oncological and surgical) in Clinical Hospital Centar Rijeka from September 2018 till May 2022
  • Patients must be in stage cT1-3 cN0-2 cM0 at the time of diagnosis and cN0 at the time of the surgery
  • Patients that are eligible for neoadjuvant oncological treatment, accepting to undergo it and complete it
  • Patients that understand, accept and have signed the approved consent form

Exclusion Criteria:

  • Patents in T4 stage and/or N3 stage and/or M1 stage at the time of diagnosis
  • Patients with inflamatory carcinoma
  • Patients with bilateral disease
  • Patients with ipsilateral reccurence
  • Patients with histological type-lobular and immunophenotype-Luminal A
  • Patients that are not eligible for oncological treatment according to protocol, either neoadjuvant or adjuvant, or oncological treatment was interrupted (aborted or completed in other institution)
  • Patients that have had previously SLNB or ALND or radiotherapy to the axillary nodes
  • Patients that have been or are treated from other malignant disease
  • Patients with hypersensitivity or allergy to radiocolloid
  • Patients without complete documentation required for this study
  • Pregnant patients
  • Psychiatric patients
  • Male patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719833


Locations
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Croatia
Ana Car Peterko
Rijeka, Croatia, 51000
Sponsors and Collaborators
Clinical Hospital Center Rijeka
Investigators
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Principal Investigator: Ana Car Peterko Clinical Hospital Centar Rijeka
Additional Information:

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Responsible Party: Ana Car Peterko, general surgeon, Clinical Hospital Center Rijeka
ClinicalTrials.gov Identifier: NCT03719833    
Other Study ID Numbers: SLNB-ACP
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Keywords provided by Ana Car Peterko, Clinical Hospital Center Rijeka:
Breast Cancer
Sentinel Lymph Node Biopsy
Neoadjuvant Chemotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases