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NCT03927027 · ClinicalTrials.gov registry record · Phase 3
Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection
A Phase 3 study of Breast Cancer Stage II and Breast Cancer Stage III, sponsored by Alliance for Clinical Trials in Oncology.
- Active
- Registry status
- Phase 3
- Development phase
- 534
- Enrollment target
- 20
- Study locations
NCT03927027: Active Phase 3 study of Breast Cancer Stage II and Breast Cancer Stage III, sponsored by Alliance for Clinical Trials in Oncology.
NCT03927027 is a Phase 3 study of Breast Cancer Stage II and Breast Cancer Stage III that is active but no longer recruiting, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 534 participants, above the 158-participant average among 22 other Breast Cancer Stage II trials with a reported enrollment target (238% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03927027, a Phase 3 study of Breast Cancer Stage II and Breast Cancer Stage III, is active but no longer recruiting, sponsored by Alliance for Clinical Trials in Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 534 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial studies how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery.
Primary Outcome
Will be assessed by the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A). The LSIDS-A questionnaire contains two different scales for intensity and distress measured from 1 (slight) to 5 (severe). The LSIDS-A questionnaire scores for swelling in the arm, decreased physical activity, pain in the arm, and loss of confidence in one's body will be evaluated for the change of baseline to 36 months using a two-sample, two-sided t-test.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- DRUG Isosulfan Blue
- PROCEDURE Axillary Lymph Node Dissection
- PROCEDURE Mapping
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- Holy Cross Hospital - Fort Lauderdale
- University of Florida Health Science Center - Gainesville - Gainesville
- Baptist MD Anderson Cancer Center - Jacksonville
- Mayo Clinic in Florida - Jacksonville
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Kendall - Miami
- Orlando Health Cancer Institute - Orlando
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
California
- UC San Diego Moores Cancer Center - La Jolla
- Contra Costa Regional Medical Center - Martinez
- Alta Bates Summit Medical Center - Summit Campus - Oakland
- Saint John's Cancer Institute - Santa Monica
Delaware
- Beebe South Coastal Health Campus - Frankford
- Helen F Graham Cancer Center - Newark
- Christiana Care Health System-Christiana Hospital - Newark
- Beebe Health Campus - Rehoboth Beach
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Colorado
- Shaw Cancer Center - Edwards
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 534 participants |
| Start Date | 2019-07-29 |
| Est. Completion | 2027-01 |
| Phase | Phase 3 |
What the registry record for NCT03927027 still lists
NCT03927027 is an interventional study that assigns participants to a tested intervention. The registered 534 participants enrollment target is mid-sized for trials with a published cap, above the 158-participant average among 22 other Breast Cancer Stage II trials with a reported enrollment target (238% higher).
The record links to 3 conditions, with Breast Cancer Stage II appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT03927027 names 20 study sites across 5 states, led by Florida, California, Delaware.
Frequently Asked Questions
What is clinical trial NCT03927027 about?
NCT03927027 is a clinical study titled "Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection". This phase III trial studies how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after sur...
What is the current status of trial NCT03927027?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 534 participants. The study started on 2019-07-29. Estimated completion is 2027-01.
What conditions does trial NCT03927027 study?
This clinical trial studies the following conditions: Breast Cancer Stage II, Breast Cancer Stage III, Breast Cancer Stage I.
What interventions are being tested in trial NCT03927027?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Isosulfan Blue (DRUG), Axillary Lymph Node Dissection (PROCEDURE), Mapping (PROCEDURE).
Who is sponsoring clinical trial NCT03927027?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03927027 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer Stage II
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03927027's enrollment target sits among peer trials
534 4th of 22 higher than 19 of 22 other Breast Cancer Stage II trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer Stage II trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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