Trial Outcomes & Findings for Upper Extremity Lymphatic Mapping for Breast Cancer Patients (NCT NCT00717886)

NCT ID: NCT00717886

Last Updated: 2015-11-20

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 13 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2015-11-20

Participant Flow

Participant milestones

Measure	Upper Extremity Lymphatic Mapping for Breast Cancer Patients Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
Overall Study STARTED	13
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Upper Extremity Lymphatic Mapping for Breast Cancer Patients Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
Overall Study Withdrawal by Subject	3
Overall Study Treatment Failure	1

Baseline Characteristics

Upper Extremity Lymphatic Mapping for Breast Cancer Patients

Baseline characteristics by cohort

Measure	Upper Extremity Lymphatic Mapping for Breast Cancer Patients n=13 Participants Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Measure	Upper Extremity Lymphatic Mapping for Breast Cancer Patients n=9 Participants Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast).	0 participants

Adverse Events

Upper Extremity Lymphatic Mapping for Breast Cancer Patients

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

Dr. Leslie Montgomery

Memorial Sloan Kettering Cancer Center

Phone: (212) 639-5386

Email: Montgoml@mskcc.org

Results disclosure agreements

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