Trial Outcomes & Findings for Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer (NCT NCT00450723)

NCT ID: NCT00450723

Last Updated: 2017-02-07

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 39 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2017-02-07

Participant Flow

Between 2001 and 2007 a prospective database was obtained of all patients undergoing internal mammary sentinel lymph node biopsies using an open or thoracoscopic approach. Radiotracer injection was peritumoral.

Participant milestones

Measure	Sentinel Lymph Node Biopsy
Overall Study STARTED	39
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Sentinel Lymph Node Biopsy
Overall Study Physician Decision	5

Baseline Characteristics

Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer

Baseline characteristics by cohort

Measure	Single Arm n=34 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=93 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants
Age, Continuous	50 years n=93 Participants
Gender Female	33 Participants n=93 Participants
Gender Male	1 Participants n=93 Participants
Region of Enrollment United States	34 participants n=93 Participants

PRIMARY outcome

Timeframe: 5 years

Outcome measures

Measure	Sentinel Lymph Node Biopsy n=34 Participants
Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy	31 participants

PRIMARY outcome

Timeframe: 5 years

Outcome measures

Measure	Sentinel Lymph Node Biopsy n=34 Participants
Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes	7 participants

PRIMARY outcome

Timeframe: 5 years

Population: Of the 39 patients enrolled, 34 had identifiable internal mammary sentinel lymph nodes.

Outcome measures

Measure	Sentinel Lymph Node Biopsy n=39 Participants
Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes	34 participants

Adverse Events

Single Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eli Avisar MD

UM/Sylvester Comprehensive Cancer Center

Phone: 305-243-4902

Email: eavisar@med.miami.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place