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Phase III Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women With Stage I or IIA Breast Cancer
Alternate Title Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer
Objectives
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Patient Characteristics: Age:
Sex:
Menopausal status:
Performance status: Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
Expected Enrollment 5300A total of 5,300 patients will be accrued for this study within an additional 3 years. Outline Patients undergo bilateral anterior iliac crest bone marrow aspiration to test for presence of micrometastases. Patients then undergo breast-conserving therapy comprising segmental mastectomy and sentinel lymph node dissection (SLND) with planned postoperative whole-breast radiotherapy and systemic adjuvant therapy. The SLND comprises ipsilateral axillary sentinel node identification and histopathology. Patients with no sentinel node identified intraoperatively and patients with sentinel node metastasis identified by hematoxylin and eosin (H&E) who choose not to be registered to ACOSOG-Z0011 undergo axillary lymph node dissection involving removal of at least level I and II nodes. All patients undergo whole-breast radiotherapy (excluding a supraclavicular field) 5 days a week for a maximum of 8 weeks. Patients are followed at 30 days; at 6, 12, 18, 24, 30, and 36 months; and then annually thereafter. Published ResultsWilke LG, McCall LM, Posther KE, et al.: Surgical complications associated with sentinel lymph node biopsy: results from a prospective international cooperative group trial. Ann Surg Oncol 13 (4): 491-500, 2006.[PUBMED Abstract] Leitch AM, Beitsch PD, McCall LM, et al.: Patterns of participation and successful patient recruitment to American College of Surgeons Oncology Group Z0010, a phase II trial for patients with early-stage breast cancer. Am J Surg 190 (4): 539-42, 2005.[PUBMED Abstract] Posther KE, McCall LM, Blumencranz PW, et al.: Sentinel node skills verification and surgeon performance: data from a multicenter clinical trial for early-stage breast cancer. Ann Surg 242 (4): 593-9; discussion 599-602, 2005.[PUBMED Abstract] Related PublicationsOlson JA Jr, McCall LM, Beitsch P, et al.: Impact of immediate versus delayed axillary node dissection on surgical outcomes in breast cancer patients with positive sentinel nodes: results from American College of Surgeons Oncology Group Trials Z0010 and Z0011. J Clin Oncol 26 (21): 3530-5, 2008.[PUBMED Abstract] Trial Lead Organizations American College of Surgeons Oncology Group
Related Information PDQ® clinical trial ACOSOG-Z0011
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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