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Surgery to Remove the Sentine...

Surgery to Remove the Sentinel Lymph Node and Axillary Lymph Nodes After Chemotherapy in Treating Women With Stage II, Stage IIIA, or Stage IIIB Breast Cancer

Last Updated: 2023-04-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

756 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2023-04-15

Brief Summary

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RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying surgery to remove the sentinel lymph node and axillary lymph nodes after chemotherapy in treating women with stage II, stage IIIA, or stage IIIB breast cancer.

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Detailed Description

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This is a multicenter study. Patients who plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes prior to registration to confirm eligibility and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection. The primary and secondary objectives of the study are described below.

Primary Objective:

1\. To determine the false negative rate for sentinel lymph node (SLN) surgery. Among the patients who have at least one sentinel lymph node identified and removed, false negative rate is defined as the number of patients declared to have no evidence of cancer in the SLN and are found to have at least one positive lymph node in the ALND divided by the total number of patients with at least one positive axillary lymph node by ALND.

Secondary Objectives:

1. To determine how the axillary ultrasound status of the patient upon completion of preoperative chemotherapy (evidence of residual lymphadenopathy on the ultrasound examination versus no evidence of lymphadenopathy in the ultrasound examination) affects the false negative rate of SLN and how sonographic findings correlate with residual disease on final pathology.
2. To determine the node status of patients after preoperative chemotherapy. Patients will be classified as node positive if they were determined to have at least one positive lymph node by SLN or ALND. Patients will be classified as node negative if all nodes examined by SLN and ALND were negative.
3. To determine whether the false-negative rate for SLN surgery after preoperative chemotherapy is related to the extent of residual cancer burden (RCB) overall, or separately in the breast or regional nodal basin.
4. To evaluate pathological complete response (pCR) rates (defined as no invasive disease in breast or lymph nodes) and disease-free survival (DFS) rates in node-positive patients receiving preoperative chemotherapy.

After completion of surgery, patients will visit the office for follow-up exams at 1-2 weeks then patients are followed every 6 months for 2 years, yearly for 2 years, then every other year for 6 years. The study closed to accrual and treatment on 5/29/12.

Conditions

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Breast Cancer

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study cohort

Patients who plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection.

Group Type OTHER

systemic chemotherapy

Intervention Type DRUG

axillary lymph node dissection

Intervention Type PROCEDURE

neoadjuvant therapy

Intervention Type PROCEDURE

sentinel lymph node biopsy

Intervention Type PROCEDURE

therapeutic conventional surgery

Intervention Type PROCEDURE

ultrasound imaging

Intervention Type PROCEDURE

Interventions

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systemic chemotherapy

Intervention Type DRUG

axillary lymph node dissection

Intervention Type PROCEDURE

neoadjuvant therapy

Intervention Type PROCEDURE

sentinel lymph node biopsy

Intervention Type PROCEDURE

therapeutic conventional surgery

Intervention Type PROCEDURE

ultrasound imaging

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

4. Histologic diagnosis of invasive breast cancer, clinical stage T0-4 N1-2 M0 (excluding inflammatory breast cancer).
5. FNA biopsy or core needle biopsy of an axillary node documenting nodal disease at time of diagnosis and prior to preoperative chemotherapy.
6. Preoperative chemotherapy must be completed or planned for patient. NOTE: Patients enrolling on studies involving preoperative chemotherapy (through cooperative groups or institutional studies) may be eligible for this study, provided sentinel node surgery prior to preoperative chemotherapy was not required in the other studies.
7. No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or treatment of hidradenitis.
8. No prior SLN surgery/excisional lymph node biopsy for pathological confirmation of axillary status.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Judy Boughey, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Site Status

Providence Cancer Center

Anchorage, Alaska, United States

Site Status

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

East Bay Radiation Oncology Center

Castro Valley, California, United States

Site Status

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, United States

Site Status

Cancer Care Center at John Muir Health - Concord Campus

Concord, California, United States

Site Status

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Valley Medical Oncology

Fremont, California, United States

Site Status

Todd Cancer Institute at Long Beach Memorial Medical Center

Long Beach, California, United States

Site Status

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Site Status

Contra Costa Regional Medical Center

Martinez, California, United States

Site Status

Community Hospital of the Monterey Peninsula Comprehensive Cancer Center

Monterey, California, United States

Site Status

Camino Medical Group - Treatment Center

Mountain View, California, United States

Site Status