A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node
A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node
RATIONALE: Surgery to remove lymph nodes in the armpit may remove cancer cells that have spread from tumors in the breast.
PURPOSE: Randomized phase III trial to determine the effectiveness of removing lymph nodes in the armpit in treating women who have stage I or stage IIA breast cancer.
OBJECTIVES:
Primary objectives:
Long term: To assess whether overall survival for patients randomized to Arm 2 (no immediate ALND) is essentially equivalent to (or better than) than that for patients assigned to Arm 1 (completion ALND).
Short term: To quantify and compare the surgical morbidities associated with SLND plus ALND versus SLND alone.
OUTLINE: This is a randomized study. After segmental mastectomy and sentinel lymph node dissection, patients are stratified according to age (50 and under vs over 50), estrogen receptor status (positive vs negative), and tumor size (no greater than 1 cm vs greater than 1 cm but no greater than 2 cm vs greater than 2 cm). Patients are randomized to one of two treatment arms.
Inclusion Criteria:
PLEASE NOTE: Patients registered to this study may undergo intra-operative or post¬operative randomization.
Patient must be female.
Patient must be at least 18 years of age.
Patient's clinical stage must be documented as tumor size less than 5 cm, with no palpable nodes and no evidence of metastatic disease (T1 or T2 N0 M0; see appendices for staging criteria) and the tumor documented as amenable to lumpectomy.
Patient must have a tissue diagnosis of invasive breast carcinoma. Note: A patient can be registered to this study if they have a cytologic diagnosis suggestive of carcinoma from a fine needle aspiration (FNA) of a palpable or non-palpable breast lesion and the investigator believes the breast lesion is clinically suspicious for invasive breast carcinoma.
Date of the patient's first tissue diagnosis of invasive breast carcinoma or cytologic diagnosis of carcinoma must be no more than 60 days prior to the SLND.
The patient who had BCT (segmental mastectomy) performed previously, and is now referred to the local investigator for SLND, is eligible if the BCT was less than or equal to 60 days prior to the SLND. NOTE: Copies of the operative and pathology reports must be submitted as part of the registration process.
Patient must have ECOG/Zubrod status =2, as documented in patient's medical record.
Patient must be available for follow-up.
Patient of childbearing potential must have a negative serum or urine pregnancy test within 14 days of beginning study interventions.
Patient must have access to radiation therapy.
A sentinel lymph node must be identified that contains metastatic breast cancer as documented by frozen section, touch prep, or H&E staining on permanent section.
Patient randomized to ALND must undergo ALND within 42 days of their SLND.
A patient with a history of a previous malignancy is eligible for this study as long as the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided that the following criteria are met:
Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures.
Patient must provide written authorization to allow the use and disclosure of their protected health information. NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registration.
Exclusion Criteria:
Birmingham, Alabama 35294-3300, United States
Little Rock, Arkansas 72205, United States
Loma Linda, California 92354, United States
Santa Monica, California 90404, United States
Aurora, Colorado 80010, United States
Washington D.C., District of Columbia 20007, United States
Lakeland, Florida 33804-1057, United States
Chicago, Illinois 60611-3013, United States
Keesler Air Force Base, Mississippi 39534-2576, United States
Columbia, Missouri 65203, United States
Lebanon, New Hampshire 03756-0002, United States
Marlton, New Jersey 08053, United States
Cooperstown, New York 13326, United States
New York, New York 10021-4885, United States
Rochester, New York 14642, United States
The Bronx, New York 10466, United States
Charlotte, North Carolina 28232-2861, United States
Winston-Salem, North Carolina 27157-1082, United States
Cleveland, Ohio 44106-5065, United States
Allentown, Pennsylvania 18105-1556, United States
Philadelphia, Pennsylvania 19104-4283, United States
Memphis, Tennessee 38120, United States
Nashville, Tennessee 37232-6860, United States
Dallas, Texas 75390-9155, United States
Lubbock, Texas 79415-3364, United States
Seattle, Washington 98122-4307, United States
La Crosse, Wisconsin 54601, United States
Milwaukee, Wisconsin 53215-5166, United States