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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: PET (positron emission tomography)

• Registration Number: NCT00233974
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief 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.

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.

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2005-02
• Study First Submitted: 2005-10-05
• Study First Submitted QC: 2005-10-05
• Study First Posted: 2005-10-06
• Study Completion: 2006-03
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-05
• Last Update Posted: 2012-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PET negative	PET (positron emission tomography)	Traditional breast Surgery and full axillary dissection
PET positive	PET (positron emission tomography)	PET-probe-guided breast resection and full axillary dissection

Primary Outcome Measures

Name	Time	Method
Improved breast conservation rates in neoadjuvant patients	12 weeks	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%.

Trial Locations

Locations (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States