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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003854
First received: November 1, 1999
Last updated: August 18, 2012
Last verified: July 2001
  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: lymphangiography
Procedure: sentinel lymph node biopsy
Procedure: therapeutic conventional surgery
Radiation: whole breast irradiation
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: 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:


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 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 116 Study Locations
Sponsors and Collaborators
American College of Surgeons
Investigators
Study Chair: Armando E. Giuliano, MD John Wayne Cancer Institute at Saint John's Health Center
  More Information

Additional Information:
Publications:

ClinicalTrials.gov Identifier: NCT00003854     History of Changes
Other Study ID Numbers: CDR0000067017, ACOSOG-Z0010, GUMC-00152
Study First Received: November 1, 1999
Last Updated: August 18, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IA breast cancer
stage IB breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 27, 2014