Protocol Number: 04-C-0114

Title:

Efficacy of Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling to Detect Axillary Lymph Node Metastases After Neoadjuvant Chemotherapy For Breast Cancer

Number:

04-C-0114

Summary:

This study will evaluate a new technique called sentinel lymph node biopsy in women with breast cancer who have been treated with chemotherapy before surgery. The sentinel lymph node is the first lymph node that filters fluid draining away from the area of the diseased breast. Thus, if the cancer spreads from the breast to lymph nodes under the arm, the sentinel lymph node is more likely than other nodes to contain cancer cells. If the sentinel node is found to be clean, women may be spared the more extensive surgery of removing many nodes for examination. Sentinel lymph node biopsy is routinely used in women with early stage (stages I and II) breast cancer who have not yet received chemotherapy. This study will examine the effectiveness of sentinel lymph node biopsy in predicting cancer spread in women who have already received chemotherapy.

Women 18 years of age and older with stage II, III, or IV breast cancer who will receive chemotherapy before surgery to treat their disease may be eligible for this study. Candidates will be screened with a medical history and physical examination, routine blood tests, and review of tumor pathology.

Patients will receive chemotherapy as part of the treatment of their breast cancer. At the time of their local surgery (breast lumpectomy/axillary lymph node dissection or modified radical mastectomy), on the morning of surgery, they will have a small amount of radioactive material injected under the areola of the breast. In the operating room, an incision will be made under the arm and the lymph node, or nodes, containing the radioactive material (the sentinel node) will be removed and sent to pathology for examination for tumor cells. The regular surgical procedure will then be performed, including removal of the axillary lymph nodes. These nodes will also be examined for tumor cells. The information will then be used to determine how accurately the sentinel lymph node predicted the presence or absence of tumor cells in the axillary nodes. Proteins in the tumor will also be analyzed to see if they can predict whether or not there are tumor cells in the sentinel lymph node and axillary lymph nodes.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Female

Referral Letter Required: Yes

Population Exclusion(s): Male

Children

Eligibility Criteria:

INCLUSION CRITERIA:

Women over age 18 with stage II, III, or IV infiltrating carcinoma of the breast. Breast cancer may be unilateral or bilateral, and unifocal or multifocal. The diagnosis of breast cancer can be made either cytologically or histologically.

Breast cancer will be staged according to the 2003 AJCC TNM classification. Breast cancer stage refers to the initial stage before neoadjuvant chemotherapy.

WBC greater than 2000, platelets greater than 50,000, Hgb greater than 7.0, PT/PTT less than 1.5 X normal.

Not pregnant.

No previous axillary surgery on the side of the SLN.

Patients who have received greater than or equal to 1 cycle of preoperative chemotherapy, which can be chemotherapy, hormonal therapy, and/or biological therapy, are eligible for SLN biopsy. All types of preoperative chemotherapy will be referred to as "preoperative" chemotherapy.

At the time of SLN biopsy following preoperative chemotherapy, women with a clinical complete response, partial response, no change, or progressive disease to preoperative therapy are eligible to undergo SLN biopsy.

EXCLUSION CRITERIA:

Previous definite breast radiotherapy to the involved breast.

Recent radionuclide scan in Nuclear Medicine (e.g. bone scan, PET scan, MUGA scan) within 3 days of the SLN biopsy.

Special Instructions: Currently Not Provided

Keywords:

Core Needle Biopsy

Lymphadenectomy

Sentinel Lymph Node Mapping

Staging

Oligo Microarray

Recruitment Keywords:

Breast Cancer

Conditions:

Breast Neoplasms

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Schwartz GF, Giuliano AE, Veronesi U; Consensus Conference Committee. Proceedings of the consensus conference on the role of sentinel lymph node biopsy in carcinoma of the breast, April 19-22, 2001, Philadelphia, Pennsylvania. Cancer. 2002 May 15;94(10):2542-51. Review. No abstract available. PMID: 12173319

Meric F, et al. Prognostic implications of pathological lymph node status after preoperative chemotherapy for operable T3N0M0 breast cancer. Ann Surg Oncol. 2000 Jul;7(6):435-40. PMID: 10894139

Kuerer HM, et al. Role of axillary lymph node dissection after tumor downstaging with induction chemotherapy for locally advanced breast cancer. Ann Surg Oncol. 1998 Dec;5(8):673-80. PMID: 9869512

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