Clinical Trials Logo

Clinical Trial Summary

The status of the axillary lymph nodes is one of the main prognostic factors in breast cancer (BC). SLNB is currently the standard staging method for patients with clinically node-negative (cN0) breast cancer. In patients with a positive SLN and in those with affected lymph nodes at the beginning (cN+), LND is the standard of treatment.


Clinical Trial Description

Breast cancer (BC) is the most common malignant tumor and the one that causes the highest number of deaths among women around the world. In Spain some 25,000 new cases are diagnosed per year, which represents almost 30% of all female tumors. In Catalonia, the incidence is 83.9 cases / 100,000 inhabitants, while the national average is 50.9 cases / 100,000 inhabitants. Thanks to screening programs and the awareness of patients and professionals, the majority of diagnosed cases are found in an early stage of the disease. In early stages, the prognosis is excellent with a 5-year survival greater than 80%. Lymph node staging: selective sentinel node biopsy (SLNB) vs axillary lymphadenectomy The status of the axillary lymph nodes is one of the main prognostic factors. Knowing the lymph node status allows the disease to be staged and modulates locoregional and systemic treatment. Lymph node staging and management of axillary disease have changed dramatically in recent decades. SLNB is currently the standard staging method for patients with clinically node-negative (cN0) breast cancer. When SLN is negative, axillary lymph node dissection (LND) can be omitted without prejudice to patient survival or locoregional control of the disease. In patients with a positive SLN and in those with affected lymph nodes at the beginning (cN+), LND is the standard of treatment. Morbidity associated with this technique affects up to 80% of patients and includes: chronic lymphedema of the upper limb (20-30%), seromas (50-60%) that in many cases require repeated punctures for drainage, infection of the wound (5-15%) that requires antibiotic treatment and sometimes drainage, decreased mobility of the arm or "frozen shoulder" (up to 10%) that requires rehabilitation treatment, neuropathic pain due to injury to the intercostobrachial nerve (5- 20%) and other less frequent ones such as hematoma or section of the long thoracic nerves (which produces a scapula alata) or the latissimus dorsi. It is obvious that all these complications affect the quality of life of patients and their emotional state. LND lengthens the days of hospitalization and this, together with the treatment of associated complications, substantially increases healthcare costs. Current focus on the initial treatment of breast cancer: primary systemic treatment Advances in biological knowledge of the disease and in systemic treatments have led to an increasing number of patients with BC starting with systemic therapy, relegating surgery to a second stage. This approach evaluates the tumor response in vivo to systemic treatment and provides critical prognostic information. In addition, the decrease and even disappearance of the tumor increases the chances of offering a conservative surgery in the breast. Response rates vary according to the biological type of tumor and the treatment used, being higher for Her2+ tumors treated with chemotherapy combined with anti-Her2 antibodies. In cN0 patients receiving neoadjuvant chemotherapy (NCT), SLNB can be performed before or after. Performing it later, together with breast surgery, has the advantage of saving the patient a surgical procedure. This strategy is supported by numerous studies that show detection and false negative (FN) rates comparable to those of patients who undergo SLNB before neoadjuvant treatment. In those patients who present clinically positive lymph nodes (cN +) before initiating neoadjuvancy, the standard strategy in relation to the axilla is to perform LND. However, in 40-50% of patients, lymph node disease disappears with treatment. Nodal response is greater in tumors with estrogen receptor negative, high histologic grade, and Her2 overexpression. It follows that up to 40-50% of unnecessary lymphadenectomies are currently being carried out. Application of the SLNB in cN + patients undergoing neoadjuvant chemotherapy Due to the benefits that SLNB represents in cN0 patients and the complete response rates in the axilla after neoadjuvant chemotherapy (NAC) in initial cN+ patients, the question arises as to whether SLNB can be valid in these patients. Previous studies in which SLNB was performed in clinically node-positive patients who received NAC have shown FN rates of up to 25%. The Spanish Society of Senology and Breast Pathology (SESPM) recommends for the validation of the SLN technique to obtain a detection rate equal to or greater than 95% and a FN rate equal to or less than 5%. International literature accepts FN rates equal to or less than 10%. The success of SLNB after NAC may be affected by altered lymphatic drainage of the breast during chemotherapy. On the other hand, it is possible that the regression of the axillary disease does not follow an orderly and uniform pattern, reducing the reliability of the technique. Finally, the impact that a FN of the technique may have on the prognosis of these patients is unknown, and it is probably not the same as in a cN0 patient. The American College of Surgeons Oncology Group (ACOSOG) conducted a phase II trial that included patients with BC T1-4, N1-2, M0. The patients received primary chemotherapy and subsequently SLNB plus LND. The detection rate was 92.9%. There was a complete pathological response in the axilla in 41% of the patients. The FN rate was 12.6% (higher than the accepted 10%). The conclusion was that SLN biopsy cannot be recommended for these patients at this time. The multicenter study SENTINA (SENTinel NeoAdjuvant), carried out in Germany and Austria, evaluated in one of its arms the performance of SLNB in cN + patients who converted to cN0 with NAC. The SLN detection rate and the FN rate were 80.1% and 14.2%, respectively. None of these studies evaluate the results of the technique based on the biological profile of the tumor or the response of the disease to treatment. It is imperative to correctly select patients and apply new strategies to optimize the results of SLNB in order to identify regression of axillary disease and to avoid radicality of LA. New strategies: placement of a marker in the metastatic lymph node. Assessment of the response according to the biological profile of the tumor and its impact on the rate of FN Axillary ultrasound prior to neoadjuvancy is performed to detect possible lymph node involvement and, together with biopsy of the suspicious node, offers a sensitivity and specificity of 25% -95% and 97% -100%, respectively. Its application could be useful to assess axillary lymph node response. Patients with normal-appearing axillary nodes on ultrasound are likely to be less likely to have residual disease. The placement of a marker in the biopsied pathological node that allows its identification during the surgical act and to check whether or not it correlates with the SLN can be useful strategies to reduce the rate of FN of the SLNB. The response of the disease in the breast and in the lymph nodes to NAC is different depending on the biological profile of the tumor. The axillary response to treatment may have an impact on the rate of FN of SLNB. Studying the results of the technique according to the biological profile of the tumor can help us to better select the candidate patients for the application of the technique. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04865549
Study type Interventional
Source Hospital Clinic of Barcelona
Contact
Status Completed
Phase N/A
Start date June 1, 2016
Completion date January 1, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Recruiting NCT04574609 - Evaluation of the Impact of the Use of Hypnotherapy Performed by a Virtual Reality Toolalong the Care Pathway of Patients Undergoing Breast Cancer Treatment. N/A
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Enrolling by invitation NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Active, not recruiting NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Active, not recruiting NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Recruiting NCT04190381 - A Study to Evaluate the Safety and Clinical Outcome of Using FR-Mask in Breast Cancer Patients With Radiation-irritated Skin After Radiotherapy N/A
Active, not recruiting NCT04088955 - A Digimed Oncology PharmacoTherapy Registry
Enrolling by invitation NCT04799535 - Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring N/A
Recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Suspended NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT02894398 - Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant Phase 2