Lymph Node Removal in Treating Women Who Have Stage I or Stage IIA Breast Cancer

Completed · Phase 3

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00003855

Run by

Alliance for Clinical Trials in Oncology

People needed

605

Starts

1999-04-01

Expected to finish

2011-02-01

Last updated by the study team

2020-04-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• NOTE: Patients with metastatic breast cancer identified by immunohistochemistry (IHC) are not eligible.
• 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:
• The patient has undergone potentially curative therapy for all prior malignancies,
• There has been no evidence of any prior malignancies for at least five years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in -situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone), and
• The patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
• 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.

You may not qualify if…

• Patient is lactating (breastfeeding).
• Patient has been previously treated with chemotherapy, estrogen receptor antagonists (i.e., Tamoxifen) or selective estrogen receptor modulators (SERMs, i.e., Raloxifene) for this invasive breast cancer.
• Patient has a previously placed pre-pectoral breast implant. NOTE: A subpectoral implant is allowed.
• Patient has concurrent invasive bilateral breast malignancies.
• Patient has clinically and radiologically identified multi-centric disease that is not amenable to a single lumpectomy.
• Patient has had previous ipsilateral axillary surgery such as excisional biopsy of lymph node(s), treatment of hidradenitis.
• Patient has a medical contraindication to ALND or is considered a poor surgical risk due to a non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
• Patient who is noted to have matted nodes or gross extranodal disease at the time of SLND.
• Patient has three or more positive sentinel nodes by frozen section, touch prep, or H\&E staining on permanent section.

Where it is running

• Providence Cancer Center — Mobile, Alabama, United States
• Mobile Infirmary Medical Center — Mobile, Alabama, United States
• CCOP - Mayo Clinic Scottsdale Oncology Program — Scottsdale, Arizona, United States
• Washington Regional Medical Center — Fayetteville, Arkansas, United States
• St. Vincent Doctors Doctors Hospital — Little Rock, Arkansas, United States
• Baptist Health Medical Center — Little Rock, Arkansas, United States
• Arkansas Cancer Research Center at University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Mercy San Juan Hospital — Carmichael, California, United States
• Arrowhead Regional Medical Center — Colton, California, United States
• Mount Diablo Regional Cancer Center — Concord, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Loma Linda University Cancer Institute at Loma Linda University Medical Center — Loma Linda, California, United States
• Summit Medical Center — Oakland, California, United States
• St. Joseph Hospital Regional Cancer Center - Orange — Orange, California, United States
• Palo Alto Medical Foundation — Palo Alto, California, United States
• Huntington Cancer Center at Huntington Hospital — Pasadena, California, United States
• Shasta Regional Medical Center — Redding, California, United States
• University of California Davis Cancer Center — Sacramento, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• UCSF Comprehensive Cancer Center — San Francisco, California, United States
• John Wayne Cancer Institute at Saint John's Health Center — Santa Monica, California, United States
• Sonoma Valley Hospital — Sonoma, California, United States
• St. Joseph's Regional Cancer Center — Stockton, California, United States
• University of Colorado Cancer Center at University of Colorado Health Sciences Center — Aurora, Colorado, United States
• University of Alabama at Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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