Sentinel Lymph Node Clinical Trial
Official title:
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Initially Node Positive Breast Cancer Patients, Could it Omit Axillary Dissection ?
The aim of this study is to determine the accuracy and safety of SLNB after neoadjuvant chemotherapy.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | April 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. Female patients with operable breast cancer who had node-positive disease at presentation and pathological confirmation with either FNA or core biopsy 2. Female Patient aged from 18 to 60 years old 3. Patients who are fit for general anesthesia. 4. Patient who agree to provide short term outcome data and agree to provide contact information to provide contact information. Exclusion Criteria: 1. Stage 4 breast cancer 2. Patient has no clinical response to NACT 3. Patients who are contraindicated for radiotherapy 4. Pregnant patients in first trimester 5. Patient with inflammatory carcinoma |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assiut University |
Cleries R, Rooney RM, Vilardell M, Espinas JA, Dyba T, Borras JM. Assessing predicted age-specific breast cancer mortality rates in 27 European countries by 2020. Clin Transl Oncol. 2018 Mar;20(3):313-321. doi: 10.1007/s12094-017-1718-y. Epub 2017 Jul 19. — View Citation
Fisher B, Bryant J, Wolmark N, Mamounas E, Brown A, Fisher ER, Wickerham DL, Begovic M, DeCillis A, Robidoux A, Margolese RG, Cruz AB Jr, Hoehn JL, Lees AW, Dimitrov NV, Bear HD. Effect of preoperative chemotherapy on the outcome of women with operable breast cancer. J Clin Oncol. 1998 Aug;16(8):2672-85. doi: 10.1200/JCO.1998.16.8.2672. — View Citation
Hery C, Ferlay J, Boniol M, Autier P. Changes in breast cancer incidence and mortality in middle-aged and elderly women in 28 countries with Caucasian majority populations. Ann Oncol. 2008 May;19(5):1009-18. doi: 10.1093/annonc/mdm593. Epub 2008 Feb 21. — View Citation
Mieog JS, van der Hage JA, van de Velde CJ. Preoperative chemotherapy for women with operable breast cancer. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD005002. doi: 10.1002/14651858.CD005002.pub2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Initially Node Positive Breast Cancer Patients, Could it Omit Axillary Dissection? | To evaluate the accuracy and safety of SLNB after neoadjuvant chemotherapy by 2 years follow up patients for recurrence clinically and radiologically by ultrasonography on axilla after one and two years . | Two year |
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