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

NCT ID: NCT00233974

Last Updated: 2012-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2006-03-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PET negative

Traditional breast Surgery and full axillary dissection

Group Type: EXPERIMENTAL

PET (positron emission tomography)

Intervention Type: PROCEDURE

Following conventional segmental mastectomy with or without needle localization, the patient will then undergo intraoperative PET-probe evaluation

PET positive

PET-probe-guided breast resection and full axillary dissection

Group Type: EXPERIMENTAL

PET (positron emission tomography)

Intervention Type: PROCEDURE

Following conventional segmental mastectomy with or without needle localization, the patient will then undergo intraoperative PET-probe evaluation

Interventions

PET (positron emission tomography)

Following conventional segmental mastectomy with or without needle localization, the patient will then undergo intraoperative PET-probe evaluation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David W. Ollila, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

CDR0000439444

Identifier Type: OTHER

Identifier Source: secondary_id

LCCC 9924

Identifier Type: -

Identifier Source: org_study_id