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

Sponsor:	American College of Surgeons
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003854

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Other: immunohistochemistry staining method Procedure: conventional surgery Procedure: lymphangiography Procedure: sentinel lymph node biopsy Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Diagnostic
Official Title:	A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women With Clinical T1-2 N0 Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	5300
Study Start Date:	April 1999

Detailed Description:

OBJECTIVES:

Estimate the prevalence and evaluate the prognostic significance of sentinel lymph node micrometastases detected by immunohistochemistry in women with stage I or IIA breast cancer.
Estimate the prevalence and evaluate the prognostic significance of bone marrow micrometastases detected by immunocytochemistry in these patients.
Evaluate the hazard rate for regional recurrence in women whose sentinel nodes are negative by hematoxylin and eosin (H&E) staining.
Provide a mechanism for identifying women whose sentinel nodes contain metastases detected by H&E so that these women can be considered as candidates for ACOSOG-Z0011.

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.

PROJECTED ACCRUAL: A total of 5,300 patients will be accrued for this study within an additional 3 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed stage I or IIA (T1 or T2 N0 M0) invasive breast carcinoma diagnosed within 60 days of sentinel lymph node dissection
- Cytologic diagnosis suggestive of carcinoma from a fine needle aspiration of a palpable or nonpalpable breast lesion allowed if clinically suspicious for invasive breast carcinoma
- Tumor must be amenable to segmental mastectomy (lumpectomy)
- No clinically and radiologically identified multicentric disease that is not amenable to a single lumpectomy
- No concurrent bilateral invasive breast malignancies
No tumors in the medial hemisphere of the breast that show complete absence of drainage to the axilla by lymphoscintigram
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age:

Over 18

Sex:

Female

Menopausal status:

Not specified

Performance status:

ECOG 0-2 OR
Zubrod 0-2

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

No renal disease that would increase surgical risk

Cardiovascular:

No cardiovascular disease that would increase surgical risk

Other:

No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, surgically treated carcinoma in situ of the cervix, or curatively treated lobular carcinoma in situ of the ipsilateral or contralateral breast with a low risk of recurrence
No other nonmalignant systemic disease that would increase surgical risk
No active connective tissue disorders
Able to undergo and have access to radiotherapy
Physically able to undergo bilateral anterior iliac crest bone marrow aspiration
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy for invasive breast cancer

Endocrine therapy:

No prior estrogen-receptor antagonists (e.g., tamoxifen) or selective estrogen-receptor modulators (e.g., raloxifene) for invasive breast cancer

Radiotherapy:

Not specified

Surgery:

See Disease Characteristics
No prior ipsilateral axillary surgery (e.g., excisional biopsy of lymph nodes or treatment of hidradenitis)
No pre-pectoral breast implant
Subpectoral implant allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003854

Show 116 Study Locations

Sponsors and Collaborators

American College of Surgeons

National Cancer Institute (NCI)

Investigators

Study Chair:

Armando E. Giuliano, MD

John Wayne Cancer Institute at Saint John's Health Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Wilke LG, McCall LM, Posther KE, Whitworth PW, Reintgen DS, Leitch AM, Gabram SG, Lucci A, Cox CE, Hunt KK, Herndon JE 2nd, Giuliano AE. Surgical complications associated with sentinel lymph node biopsy: results from a prospective international cooperative group trial. Ann Surg Oncol. 2006 Apr;13(4):491-500. Epub 2006 Mar 2.

Leitch AM, Beitsch PD, McCall LM, Posther K, Newman LA, Herndon JE 2nd, Hunt KK, Giuliano AE. 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. 2005 Oct;190(4):539-42.

Posther KE, McCall LM, Blumencranz PW, Burak WE Jr, Beitsch PD, Hansen NM, Morrow M, Wilke LG, Herndon JE 2nd, Hunt KK, Giuliano AE. Sentinel node skills verification and surgeon performance: data from a multicenter clinical trial for early-stage breast cancer. Ann Surg. 2005 Oct;242(4):593-9; discussion 599-602.

Olson JA Jr, McCall LM, Beitsch P, Whitworth PW, Reintgen DS, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Giuliano AE; American College of Surgeons Oncology Group Trials Z0010 and Z0011. 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. 2008 Jul 20;26(21):3530-5.

Study ID Numbers:	CDR0000067017, ACOSOG-Z0010, GUMC-00152
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003854 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 05, 2009