Molecular Marker Profiling of Axillary Lymph Nodes in Predicting Response in Patients With Locally Advanced or Metastatic Breast Cancer Who Are Undergoing Chemotherapy Followed By Surgery

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00233974
First received: October 5, 2005
Last updated: March 5, 2012
Last verified: March 2012
  Purpose

RATIONALE: Comparing results of diagnostic procedures, such as molecular marker profiling, done before and after chemotherapy, may help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This phase II trial is studying how well molecular marker profiling of axillary lymph nodes works in predicting response in patients with locally advanced or metastatic breast cancer who are undergoing chemotherapy followed by surgery.


Condition Intervention Phase
Breast Cancer
Procedure: PET (positron emission tomography)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Axillary Lymph Nodes and PET (Positron Emission Tomography) Probe-Guided Surgical Resection in Locally Advanced Breast Cancer Patients: Molecular Marker Profile and Response to Neoadjuvant Chemotherapy

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Improved breast conservation rates in neoadjuvant patients [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Determine if an intraoperative positron emission tomography (PET) probe can improve breast conservation rates in patients treated initially with neoadjuvant chemotherapy by at least 2%.


Enrollment: 15
Study Start Date: May 2002
Study Completion Date: March 2006
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PET negative
Traditional breast Surgery and full axillary dissection
Procedure: PET (positron emission tomography)
Following conventional segmental mastectomy with or without needle localization, the patient will then undergo intraoperative PET-probe evaluation
Experimental: PET positive
PET-probe-guided breast resection and full axillary dissection
Procedure: PET (positron emission tomography)
Following conventional segmental mastectomy with or without needle localization, the patient will then undergo intraoperative PET-probe evaluation

Detailed Description:

OBJECTIVES:

Primary

  • Determine whether molecular markers in pretreatment axillary lymph node metastases can predict pathologic response to neoadjuvant chemotherapy in patients with locally advanced or early metastatic breast cancer.

Secondary

  • Compare molecular markers in axillary lymph node metastases with those in the primary breast tumor (obtained in protocol UNC-LCCC-9819) in patients treated with neoadjuvant chemotherapy.
  • Determine changes in molecular markers in lymph nodes before and after treatment with neoadjuvant chemotherapy in these patients.
  • Determine the proportion of clinical axillary lymph node-negative patients who have histopathologically node-positive disease identified by sentinel lymph node biopsy.
  • Determine the rate of breast preservation in patients with large breast cancers treated with neoadjuvant chemotherapy followed by fludeoxyglucose F 18 positron emission tomography probe-guided surgical resection.

OUTLINE: Patients undergo open surgical biopsy of axillary lymph nodes OR intraoperative lymphatic mapping and sentinel lymphadenectomy for clinically node-positive or clinically node-negative disease, respectively, before and after neoadjuvant chemotherapy. The axillary lymph node tissue is examined for molecular and protein markers by immunohistochemistry and fluorescence in situ hybridization. Patients also undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET) once before and then once after neoadjuvant chemotherapy. Beginning 1 hour before surgery, patients receive an injection of FDG and then undergo conventional segmental mastectomy (lumpectomy) with or without needle localization followed by FDG-PET probe-guided surgical resection of any remaining FDG-avid tumor tissue.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 5 years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive breast cancer by fine needle aspiration or biopsy

    • Locally advanced or early metastatic disease
  • Clinically or radiographically measurable disease
  • Planning to receive neoadjuvant chemotherapy for locally advanced or early metastatic disease
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • Not specified

Sex

  • Not specified

Menopausal status

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for this malignancy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  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: NCT00233974

Locations
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: David W. Ollila, MD UNC Lineberger Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00233974     History of Changes
Other Study ID Numbers: LCCC 9924, CDR0000439444
Study First Received: October 5, 2005
Last Updated: March 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

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

ClinicalTrials.gov processed this record on August 28, 2014