Axillary Lymph Node Status After Completion of Preoperative Neoadjuvant Systemic Chemotherapy in Patients
Axillary Lymph Node Status After Completion of Preoperative Neoadjuvant Systemic Chemotherapy in Patients
The purpose of the present proposed clinical trial will be to assess the utility of SLN
 mapping and biopsy for predicting the final axillary status after completion of preoperative
 neoadjuvant systemic chemotherapy in patients who had biopsy-proven positive axillary lymph
 nodes at initial presentation
Multiple retrospective reports have verified the overall utility of post-treatment sentinel
 lymph node (SLN) mapping and biopsy for assessing the final axillary lymph node status in
 breast cancer patients who have undergone preoperative neoadjuvant systemic chemotherapy.
 However, to date, only one report, in abstract form, currently exists within the literature
 which specifically assesses the utility of post-treatment SLN mapping and biopsy after
 completion of preoperative neoadjuvant systemic chemotherapy in patients with biopsy-proven
 positive axillary lymph nodes at initial presentation.

 The purpose of the present proposed clinical trial will be to assess the utility of SLN
 mapping and biopsy for predicting the final axillary status after completion of preoperative
 neoadjuvant systemic chemotherapy in patients who had biopsy-proven positive axillary lymph
 nodes at initial presentation.

 All eligible patients must have biopsy-proven invasive breast cancer and must also have
 biopsy-proven involvement of the axillary lymph nodes at initial presentation. Biopsy-proven
 involvement of the axillary lymph nodes at initial presentation will be based on fine needle
 aspiration (FNA) cytology, core/Tru-cut biopsy, or pre-treatment SLN biopsy. All eligible
 patients will have undergone preoperative neoadjuvant systemic chemotherapy.

 After completion of preoperative neoadjuvant systemic chemotherapy and on the day of
 definitive breast cancer surgery, patients will be injected intradermally with approximately
 400 microcuries of Tc-99m sulfur colloid. Patients will undergo preoperative
 lymphoscintigraphy in the nuclear medicine department to access axillary and extra-axillary
 sites of localization. Intraoperatively, patients will also be injected with approximately 4
 to 5 mL of 1% isosulfan blue dye (by intradermal, intraparenchymal, or subareolar route).
 Patients will undergo intraoperative identification and biopsy of all SLN candidates. A
 confirmatory axillary lymph node dissection will then be performed on all patients.

 The SLN mapping and biopsy procedure that we are proposing to perform on these breast cancer
 patients with known positive axillary lymph nodes at initial presentation will be done in an
 identical fashion to the SLN mapping and biopsy procedure that is currently performed as a
 routine and acceptable standard of care on every breast cancer patient with a clinically
 negative axilla at presentation.

 The primary endpoints of this study would be address the success of identification of the SLN
 and the accuracy of the SLN mapping and biopsy procedure in women having undergone
 preoperative neoadjuvant systemic chemotherapy who had biopsy-proven involvement of their
 axillary lymph nodes at initial presentation. We would like to show that the proportion of
 women with false negative SLN biopsy results is less than 10%.

 The study will require a minimum of 49 women with newly diagnosed breast cancer with
 biopsy-proven involvement of their axillary lymph nodes at initial presentation that have
 undergone preoperative neoadjuvant systemic chemotherapy. The study accrual time may take in
 the range of approximately 24 to 36 months to complete.
Inclusion Criteria:

 -  Patients must be female and 18 years of age or older.

 -  Patients must have a clinical T1, T2, or T3 tumor size.

 -  Patients must have a histopathologic tissue diagnosis of breast cancer by a core-type
 of breast biopsy

 -  Patients must have had biopsy-proven involvement of the axillary lymph nodes at
 initial presentation based on fine needle aspiration (FNA) cytology, core/Tru-cut
 biopsy, or pre-treatment SLN biopsy that will require an axillary lymph node
 dissection to be performed at the time of the definitive breast cancer surgery.

 -  Patients will have had to undergone preoperative neoadjuvant systemic chemotherapy.

 -  Patients may be candidates for either lumpectomy or mastectomy.

 -  Patients may have a history of a previously treated metachronous contralateral breast
 cancer in the past.

 -  Patients may have synchronous bilateral breast cancer.

 Exclusion Criteria:

 -  Patients must not be pregnant (The absence of pregnancy must be documented by any one
 of the following: negative serum pregnancy test, the history of surgical
 sterilization, or the absence of menstruation for at least six months prior to
 enrollment in the study)

 -  Patients may not have a history of previous treated ipsilateral breast cancer in the
 past.