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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIDiagnostic, TreatmentClosedOver 18NCI, OtherCDR0000067017
ACOSOG-Z0010, GUMC-00152, NCT00003854

Trial Description

Summary

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.

Further Study Information

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 until 10 years after surgery.

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

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

American College of Surgeons

National Cancer Institute

Armando E. GiulianoStudy Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003854
ClinicalTrials.gov processed this data on November 12, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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