Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With Breast Cancer

NCT00932035 | Terminated Phase 1 Results DMC

• 1 other identifier: 11130
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 3

Brief Summary

This pilot phase I and randomized phase II trial studies the best way to perform axillary lymph node preservation surgery and to see how well it works in preventing lymphedema in patients with breast cancer. Lymph node mapping may help in planning surgery to remove breast cancer and affected lymph nodes. It is not yet known whether reverse mapping guided axillary lymph node dissection is more effective than standard axillary lymph node dissection in preventing lymphedema.

Conditions

Breast Cancer

Keywords

breast cancer; axillary mapping; lymphedema

Outcome Measures

Primary Outcomes (3)

• Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein

  A Fisher's exact test with a one-sided alpha of 0.05 will be used to determine if the percentage of patients with arm lymphatics above, around, or below the axillary vein in the standard dissection group is superior to the experimental dissection group.

  Up to 4 years

• Percentage of Patients With Positive Axillary Reverse Mapping (ARM) Identified Nodes

  A Fisher's exact test with a one-sided alpha of 0.05 will be used to determine if the percentage of patients with positive ARM identified nodes excised in the standard dissection group is superior to the experimental dissection group.

  Up to 4 years

• Percentage of Patients With Lymphedema

  Difference between arms in patients developing lymphedema at any point during the study will be evaluated using chi-squared tests.

  Up to 4 years

Study Arms (2)

Arm I (reverse mapping guided axillary lymph node dissection)

EXPERIMENTAL

Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.

Procedure: axillary lymph node dissection; Drug: isosulfan blue based lymphatic mapping; Procedure: quality-of-life assessment; Other: Questionnaire administration

Arm II (control)

ACTIVE COMPARATOR

Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.

Drug: isosulfan blue based lymphatic mapping; Procedure: axillary lymph node dissection; Procedure: quality-of-life assessment; Other: Questionnaire administration

Interventions

axillary lymph node dissection PROCEDURE

Undergo reverse mapping-guided axillary lymph node dissection

Also known as: isosulfan blue dye, Lymphazurin blue dye

Arm I (reverse mapping guided axillary lymph node dissection)

isosulfan blue based lymphatic mapping DRUG

Also known as: isosulfan blue dye, Lymphazurin blue dye

Arm I (reverse mapping guided axillary lymph node dissection); Arm II (control)

quality-of-life assessment PROCEDURE

Ancillary studies

Arm I (reverse mapping guided axillary lymph node dissection); Arm II (control)

Questionnaire administration OTHER

Ancillary studies

Arm I (reverse mapping guided axillary lymph node dissection); Arm II (control)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients diagnosed with breast cancer with a planned axillary lymph node dissection planned for breast cancer

You may not qualify if:

• Prior lymphedema in either arm
• Prior history of axillary surgery (except for sentinel node biopsies)
• Prior history of chest/axillary radiation
• Need for bilateral axillary node dissection surgery
• Prior neurologic deficits (either motor or sensory) in ipsilateral arm
• Known allergy to vital blue dyes
• No prior diagnosis of inflammatory breast cancer
• Cannot be pregnant or planning to continue breast-feeding immediately after surgery

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599-1350, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Limitations and Caveats

Study was terminated early due to loss of principal investigator. As a result accrual of subjects and data collection are incomplete.

Results Point of Contact

• Title: Carolyn Behrendt, Ph.D.
• Organization: City of Hope

Cbehrendt@coh.org

(626)359-8111

Study Officials

• Steven Chen, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: July 2, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 7, 2017
• Results First Posted: June 7, 2017

Record last verified: 2017-05

Locations

US (3)