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Sentinel Lymph Node Mapping and Biopsy For Predicting the Axillary Lymph Node Status After Completion of Preoperative Neoadjuvant Systemic Chemotherapy in Patients Who Had Biopsy-Proven Axillary Lymph Node Involvement at Initial Presentation


N/A
18 Years
N/A
Not Enrolling
Female
Invasive Breast Cancer

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Trial Information

Sentinel Lymph Node Mapping and Biopsy For Predicting the Axillary Lymph Node Status After Completion of Preoperative Neoadjuvant Systemic Chemotherapy in Patients Who Had Biopsy-Proven Axillary Lymph Node Involvement 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

the proportion of women with successful identification of the SLN with a 95% confidence interval of not greater than 10%.

Outcome Time Frame:

up to 36 months

Safety Issue:

No

Principal Investigator

Stephen P Povoski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-06077

NCT ID:

NCT00507611

Start Date:

October 2006

Completion Date:

May 2010

Related Keywords:

  • Invasive Breast Cancer
  • breast
  • sentinel lymph node
  • node mapping
  • Breast Neoplasms

Name

Location

Ohio State UniversityColumbus, Ohio  43210