Clinical Trials

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

Location:

Trial status:

Inactive

Why is this study being done?

OBJECTIVES:

Primary

- To determine the false negative rate for sentinel lymph node (SLN) surgery in women with node-positive breast cancer.

Secondary

- To determine how the axillary ultrasound status of the patient upon completion of neoadjuvant chemotherapy (evidence of residual lymphadenopathy on the ultrasound examination vs no evidence of lymphadenopathy in the ultrasound examination) affects the false negative rate of SLN.

- To determine how the axillary ultrasound status of the patient upon completion of neoadjuvant chemotherapy (sonographic findings) correlates with residual disease on final pathology.

- To determine the node status of patients after neoadjuvant chemotherapy.

- To determine whether the false-negative rate for SLN surgery after neoadjuvant chemotherapy is related to the extent of residual cancer burden overall, or separately in the breast or regional nodal basin.

- To evaluate pathological complete response rates (defined as no invasive disease in breast or lymph nodes) and disease-free survival rates in node-positive patients receiving neoadjuvant chemotherapy.

OUTLINE: This is a multicenter study.

Patients receive neoadjuvant chemotherapy at the discretion of the treating physician. 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 including sentinel lymph node and axillary lymph node dissection.

After completion of study treatment, patients are followed every 6 months for 2 years, yearly for 2 years, then every other year for 6 years.

Who is eligible to participate?

DISEASE CHARACTERISTICS:

- Histologically confirmed invasive breast cancer

- Clinical stage II-IIIB (T0-4, N1-2, M0) disease, excluding inflammatory breast cancer

- Node-positive disease by fine needle aspiration or core needle biopsy of an axillary node at time of diagnosis and prior to preoperative chemotherapy

- Must have completed or plan to undergo neoadjuvant chemotherapy

- 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 these studies

PATIENT CHARACTERISTICS:

- ECOG or Zubrod performance status 0-1

- Negative pregnancy test

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior ipsilateral axillary surgery (e.g., excisional biopsy of lymph node[s]) or treatment of hidradenitis

- No prior sentinel lymph node surgery or excisional lymph node biopsy for pathological confirmation of axillary status

Last updated: 07/11/2012

NCT ID:

NCT00881361