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

Not Recruiting

Trial ID: NCT00881361

Purpose

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.

Official Title

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

Stanford Investigator(s)

Frederick M. Dirbas, MD
Frederick M. Dirbas, MD

Associate Professor of Surgery (General Surgery)

Eligibility


Eligibility Criteria:

   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
   axillary status.

Intervention(s):

drug: systemic chemotherapy

procedure: axillary lymph node dissection

procedure: neoadjuvant therapy

procedure: sentinel lymph node biopsy

procedure: therapeutic conventional surgery

procedure: ultrasound imaging

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061

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