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
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
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.
This is a multicenter study. Patients who plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes prior to registration to confirm eligibility and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection. The primary and secondary objectives of the study are described below.
Primary Objective:
1. To determine the false negative rate for sentinel lymph node (SLN) surgery. Among the patients who have at least one sentinel lymph node identified and removed, false negative rate is defined as the number of patients declared to have no evidence of cancer in the SLN and are found to have at least one positive lymph node in the ALND divided by the total number of patients with at least one positive axillary lymph node by ALND.
Secondary Objectives:
After completion of surgery, patients will visit the office for follow-up exams at 1-2 weeks then patients are followed every 6 months for 2 years, yearly for 2 years, then every other year for 6 years. The study closed to accrual and treatment on 5/29/12.
Eligibility Criteria:
Little Rock, Arkansas 72205, United States
Concord, California 94524-4110, United States
Long Beach, California 90806, United States
Los Angeles, California 90089-9181, United States
Monterey, California 93940, United States
Orange, California 92868, United States
Aurora, Colorado 80045, United States
Washington D.C., District of Columbia 20007, United States
Washington D.C., District of Columbia 20010, United States
Miami, Florida 33136, United States
Maywood, Illinois 60153, United States
Ottawa, Illinois 61350, United States
Peoria, Illinois 61615, United States
Beech Grove, Indiana 46107, United States
Indianapolis, Indiana 46202-5289, United States
La Porte, Indiana 46350, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
Kansas City, Kansas 66160-7357, United States
Wichita, Kansas 67214, United States
Boston, Massachusetts 02115, United States
St Louis, Missouri 63110, United States
Billings, Montana 59102, United States
Missoula, Montana 59807, United States
Marlton, New Jersey 08053, United States
Voorhees Township, New Jersey 08043, United States
Albuquerque, New Mexico 87110, United States
New York, New York 10032, United States
Poughkeepsie, New York 12601-3990, United States
Rochester, New York 14642, United States
The Bronx, New York 10461, United States
Chapel Hill, North Carolina 27599-7295, United States
Charlotte, North Carolina 28232-2861, United States
Charlotte, North Carolina 28233-3549, United States
Winston-Salem, North Carolina 27157-1096, United States
Portland, Oregon 97213-2967, United States
Allentown, Pennsylvania 18105, United States
Hershey, Pennsylvania 17033-0850, United States
Philadelphia, Pennsylvania 19107-5541, United States
Upland, Pennsylvania 19013, United States
Wilkes-Barre, Pennsylvania 18711, United States
Charleston, South Carolina 29425, United States
Spartanburg, South Carolina 29303, United States
Amarillo, Texas 79106, United States
Dallas, Texas 75390, United States
Morgantown, West Virginia 26506, United States
Parkersburg, West Virginia 26102, United States
Green Bay, Wisconsin 54301-3526, United States
Green Bay, Wisconsin 54311, United States
Madison, Wisconsin 53792-6164, United States
Milwaukee, Wisconsin 53215, United States