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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233974
• Other study ID #: LCCC 9924
• Secondary ID: CDR0000439444
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2005
• Last updated: March 5, 2012
• Start date: May 2002
• Est. completion date: March 2006

Study information

• Verified date: March 2012
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2006
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• PET (positron emission tomography)
Following conventional segmental mastectomy with or without needle localization, the patient will then undergo intraoperative PET-probe evaluation

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved breast conservation rates in neoadjuvant patients	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%.	12 weeks	No