Axillary Lymph Node Status After Completion of Preoperative Neoadjuvant Systemic Chemotherapy in Patients

NCT00507611 | Completed DMC

• 1 other identifier: OSU-06077
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Invasive Breast Cancer

Keywords

breast; sentinel lymph node; node mapping

Outcome Measures

Primary Outcomes (3)

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

  up to 36 months

• the accuracy with a 95% confidence interval of not greater than 10%.

  up to 36 months

• Insure the proportion of women with false negative SLN results do not exceed 10%

  up to 36 months

Study Arms (1)

Single-arm

OTHER

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.

Procedure: Sentinel node mapping

Interventions

Sentinel node mapping PROCEDURE

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.

Also known as: SLN mapping

Single-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stephen Povoski: lead

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

Study Officials

• Stephen P Povoski, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2007
• First Posted: July 26, 2007
• Study Start: October 1, 2006
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: September 25, 2012

Record last verified: 2012-09

Locations

US (1)