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Surgery to Remove the Sentinel Lymph Node and Axillary Lymph Nodes After Chemotherapy in Treating Women With Stage II, Stage IIIA, or Stage IIIB Breast Cancer
Trial ID: NCT00881361
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying surgery to remove the sentinel lymph node and axillary lymph nodes after chemotherapy in treating women with stage II, stage IIIA, or stage IIIB breast cancer.
A Phase II Study Evaluating the Role of Sentinel Lymph Node Surgery and Axillary Lymph Node Dissection Following Preoperative Chemotherapy in Women With Node Positive Breast Cancer (T1-4, N1-2, M0) at Initial Diagnosis
1. ≥ 18 years old
2. ECOG/Zubrod Performance Status 0-1
3. Female. Note: Men are excluded from this study because the number of men with breast
cancer is insufficient to provide a statistical basis for assessment of effects in
this subpopulation of people with breast cancer.
4. Histologic diagnosis of invasive breast cancer, clinical stage T0-4 N1-2 M0 (excluding
inflammatory breast cancer).
5. FNA biopsy or core needle biopsy of an axillary node documenting nodal disease at time
of diagnosis and prior to preoperative chemotherapy.
6. Preoperative chemotherapy must be completed or planned for patient. NOTE: Patients
enrolling on studies involving preoperative chemotherapy (through cooperative groups
or institutional studies) may be eligible for this study, provided sentinel node
surgery prior to preoperative chemotherapy was not required in the other studies.
7. No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or
treatment of hidradenitis.
8. No prior SLN surgery/excisional lymph node biopsy for pathological confirmation of
drug: systemic chemotherapy
procedure: axillary lymph node dissection
procedure: neoadjuvant therapy
procedure: sentinel lymph node biopsy
procedure: therapeutic conventional surgery
procedure: ultrasound imaging
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Cancer Clinical Trials Office