Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Initially Node Positive Breast Cancer Patients, Could it Omit Axillary Dissection ?
Study Details
Study Description
Brief Summary
The aim of this study is to determine the accuracy and safety of SLNB after neoadjuvant chemotherapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Breast cancer is the most common cancer among women. The morbidity and mortality of breast cancer are much higher than those observed with other female cancers . The incidence of breast cancer increases with age.
Approximately 1.7 million new cases are estimated to occur worldwide, and mortality is increasing in developing countries, primarily because the disease is not diagnosed until it is in an advanced stage
Neoadjuvant chemotherapy (NACT) is considered the standard of care for the anagement of locally advanced breast cancer and although this treatment has historically been reserved for those with inoperable breast cancer now is increasingly being used for women with earlier stage disease.
. Encouraging results obtained with neoadjuvant chemotherapy in have resulted in clinicians using preoperative chemotherapy for patients with smaller tumors.
Neoadjuvant chemotherapy (NACT) could reduce surgical morbidity of the breast and axilla. By down staging of the tumor, NACT can convert patients who are candidates for mastectomy to breast-conserving surgery (BCS) candidates .
Furthermore, it has potential to reduce excision volumes in patients with large tumors who are already candidates for BCS. Another surgical advantage is down staging of the axilla so that axillary lymph node dissection can be avoided .
In the treatment of breast cancer, sentinel lymph node biopsy (SLNB) has replaced axillary lymph node dissection (ALND) as the staging procedure for patients with clinically node-negative disease. It provides accurate assessment of histological nodal status, guides additional therapies and is associated with less morbidity than ALND. Historically, patients who were clinically node-negative would undergo SLNB, whereas patients who were node-positive underwent ALND. SLNB in the neoadjuvant setting has become a topic of debate. Unfortunately, the reliability of SLNB after NAC remains questionable. Chemotherapy causes fibrosis, fat necrosis and granulation tissue formation, which alters lymphatic drainage patterns.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: female with breast cancer and positive axillary lymphnodes female patients with breast cancer with initially positive axillary lymphnodes who underwent neoadjuvant chemotherapy |
Procedure: sentinle lymphnode biopsy
intraoperative sentinle lymphnode biopsy
|
Outcome Measures
Primary Outcome Measures
- Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Initially Node Positive Breast Cancer Patients, Could it Omit Axillary Dissection? [Two year]
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 .
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female patients with operable breast cancer who had node-positive disease at presentation and pathological confirmation with either FNA or core biopsy
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Female Patient aged from 18 to 60 years old
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Patients who are fit for general anesthesia.
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Patient who agree to provide short term outcome data and agree to provide contact information to provide contact information.
Exclusion Criteria:
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Stage 4 breast cancer
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Patient has no clinical response to NACT
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Patients who are contraindicated for radiotherapy
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Pregnant patients in first trimester
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Patient with inflammatory carcinoma
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Assiut University
Investigators
- Study Director: Mahmoud thabet, Assistant lecture, Assiut University
- Study Director: negm eldein abulnaga, lecturer of general surgery, Assiut University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- sentinel L.N in breast cancer