Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer

Completed · Phase 3

Conditions studied: Breast Cancer

In brief

RATIONALE: Biopsy of sentinel lymph nodes and bone marrow may improve the ability to detect and determine the extent of cancer. PURPOSE: Phase III prognostic study of sentinel lymph node metastases and bone marrow metastases in women who have stage I or stage IIA breast cancer.

Key facts

Study ID: NCT00003854
Run by: Alliance for Clinical Trials in Oncology
People needed: 4590
Starts: 1999-04-01
Expected to finish: 2011-07-01
Last updated by the study team: 2016-07-13

Who can join

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

You may qualify if…

Patient must be female.
Patient's clinical stage must be I or II (T1 or T2 N0 M0) and the tumor must be amenable to segmental mastectomy (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.
The date of the patient's first tissue diagnosis of invasive breast carcinoma or cytologic diagnosis of breast carcinoma must be no more than 60 days prior to SLND.
The patient who had segmental mastectomy (lumpectomy) performed previously, and is now referred to the local investigator for SLND, is eligible if the lumpectomy was less than or equal to 60 days prior to the SLND. Copies of the operative and pathology reports must be submitted as a part of the registration process.
Patient must have ECOG/Zubrod status of ≤2, as documented in patient's medical record.
Patient must be available for follow-up.
The 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.
Signed and dated informed consent is obtained prior to patient registration.
Patients of childbearing potential must have a negative serum or urine pregnancy test within 14 days of beginning study interventions.
Patient must be able to physically undergo bilateral anterior iliac crest bone marrow aspiration.

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 is considered a poor surgical risk due to a non-malignant systemic disease (cardiovascular, renal, etc.), which would preclude the treatment options.
Patient has concurrent bilateral invasive breast malignancies.
Patient is not able to undergo and does not have access to radiation therapy as describedin Adjuvant Radiation Therapy in the Interventions section of the protocol.
Patients with active connective tissue disorders and those that live too far from a radiation treatment center, for example, would not be eligible.
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.

Where it is running

Mobile Infirmary Medical Center — Mobile, Alabama, United States
Providence Hospital - Mobile AL — Mobile, Alabama, United States
Mayo Clinic Scottsdale — 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
Kaiser Permanente Medical Center - Los Angeles — Los Angeles, California, United States
Summit Medical Center — Oakland, California, United States
St. Joseph Hospital - Orange — Orange, California, United States
Huntington Memorial Hospital — Pasadena, California, United States
University of California Davis Cancer Center — Sacramento, California, United States
Donald N. Sharp Memorial Community Hospital — San Diego, California, United States
UCSF Comprehensive Cancer Center — San Francisco, California, United States
John Wayne Cancer Institute — Santa Monica, California, United States
Memorial Hospital Cancer Center — Colorado Springs, Colorado, United States
University of Colorado Cancer Center — Denver, Colorado, United States
University of Connecticut Health Center — Farmington, Connecticut, United States
CCOP - Christiana Care Health Services — Wilmington, Delaware, United States
Lombardi Cancer Center — Washington D.C., District of Columbia, United States
Morton Plant Mease Health Care — Clearwater, Florida, United States
Lakeland Regional Medical Center — Lakeland, Florida, United States
Watson Clinic — Lakeland, Florida, United States
Bayfront Medical Center — St. Petersburg, Florida, United States
Martin Memorial Cancer Medical Center — Stuart, Florida, United States
University of Alabama at Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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