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
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.
Drug: systemic chemotherapy
Procedure: axillary lymph node dissection
Procedure: neoadjuvant therapy
Procedure: sentinel lymph node biopsy
Procedure: therapeutic conventional surgery
Procedure: ultrasound imaging
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Evaluating the Role of Sentinel Lymph Node Surgery and Axillary Lymph Node Dissection Following Preoperative Chemotherapy in Women With Node Positive Breast Cancer (T1-4, N1-2, M0) at Initial Diagnosis|
- False negative rate defined as number of patients with no positive lymph nodes after SLN surgery and ≥ 1 positive lymph node by axillary lymph node dissection (ALND) divided by number of patients with ≥ 1 positive lymph node by ALND [ Designated as safety issue: No ]
- Axillary ultrasound status after completion of preoperative chemotherapy (i.e., ultrasound evidence of residual lymphadenopathy versus no evidence of lymphadenopathy) [ Designated as safety issue: No ]
- Node status after preoperative chemotherapy (positive status defined as ≥ 1 positive lymph node by SLN or ALND) [ Designated as safety issue: No ]
- Extent of residual cancer burden [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
- To determine the false negative rate for sentinel lymph node (SLN) surgery in women with node-positive breast cancer.
- 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.