Breast CancerPhase 1/2NCT00932035
Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With Breast Cancer
A Phase 1/2 study testing axillary lymph node dissection, isosulfan blue based lymphatic mapping and quality-of-life assessment in people with Breast Cancer, run by City of Hope Medical Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- axillary lymph node dissection, isosulfan blue based lymphatic mapping and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2009to May 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with breast cancer with a planned axillary lymph node dissection planned for breast cancer
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of North Carolina
Chapel Hill, North Carolina, 27599-1350
City of Hope Medical Center
Duarte, California, 91010
University of California, Davis Medical Center
Sacramento, California, 95817
About this study
Official title: Reducing Extremity Lymphedema Through Axillary Lymphatic Preservation Surgery
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.
Read the detailed description
PRIMARY OBJECTIVES: I. To produce a map of the lymphatic drainage of the upper extremity as it relates to breast drainage, to determine the proportion of women undergoing axillary lymphadenectomy at risk for lymphedema. II. To determine if blue lymphatics contain lymph node metastases. III. To evaluate the incidence of lymphedema and associated other surgical related quality of life in those undergoing this procedure as compared to the current standard of care.
OUTLINE: This is a phase I study followed by a randomized phase II study.
PILOT PORTION: Patients receive isosulfan blue dye subcutaneously (SC) and then undergo reverse mapping-guided axillary lymph node dissection.
RANDOMIZED PORTION: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive isosulfan blue dye subcutaneously (SC) and then undergo reverse mapping-guided axillary lymph node dissection. ARM II: Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
After completion of study treatment, patients are followed up periodically.
- Conditions
- Breast Cancer
- Being tested
- axillary lymph node dissection, isosulfan blue based lymphatic mapping, quality-of-life assessment, Questionnaire administration
- Keywords
- breast cancer, axillary mapping, lymphedema
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axillary lymph node dissectionProcedure or surgery
Also called isosulfan blue dye, Lymphazurin blue dye
Undergo reverse mapping-guided axillary lymph node dissection
isosulfan blue based lymphatic mappingDrug
Also called isosulfan blue dye, Lymphazurin blue dye
axillary lymph node dissectionProcedure or surgery
Also called isosulfan blue dye, Lymphazurin blue dye
Undergo standard axillary lymph node dissection
quality-of-life assessmentProcedure or surgery
Ancillary studies
Questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: isosulfan blue based lymphatic mapping; Procedure: axillary lymph node dissection; Procedure: quality-of-life assessment; Other: Questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Loss of principal investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Steven Chen, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932035
- Sponsor's protocol ID
- 11130
- Status last verified
- May 2017
- First submitted
- 29 Jun 2009
- Last updated
- 7 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Extremity Lymphedema Through Axillary Lymphatic Preservation Surgery
- ClinicalTrials.gov ID
- NCT00932035
- Acronym / sponsor ID
- 11130
- Conditions
- Breast Cancer
- Keywords
- breast cancer, axillary mapping, lymphedema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of principal investigator
- Enrolment
- 39 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Posted 7 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES: I. To produce a map of the lymphatic drainage of the upper extremity as it relates to breast drainage, to determine the proportion of women undergoing axillary lymphadenectomy at risk for lymphedema. II. To determine if blue lymphatics contain lymph node metastases. III. To evaluate the incidence of lymphedema and associated other surgical related quality of life in those undergoing this procedure as compared to the current standard of care.
OUTLINE: This is a phase I study followed by a randomized phase II study.
PILOT PORTION: Patients receive isosulfan blue dye subcutaneously (SC) and then undergo reverse mapping-guided axillary lymph node dissection.
RANDOMIZED PORTION: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive isosulfan blue dye subcutaneously (SC) and then undergo reverse mapping-guided axillary lymph node dissection. ARM II: Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
After completion of study treatment, patients are followed up periodically.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (reverse mapping guided axillary lymph node dissection) | Experimental | Procedure: axillary lymph node dissection, Drug: isosulfan blue based lymphatic mapping, Procedure: quality-of-life assessment, Other: Questionnaire administrationPatients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection. |
| Arm II (control) | Active comparator | Drug: isosulfan blue based lymphatic mapping, Procedure: axillary lymph node dissection, Procedure: quality-of-life assessment, Other: Questionnaire administrationPatients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with breast cancer with a planned axillary lymph node dissection planned for breast cancer
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| axillary lymph node dissectionAlso: isosulfan blue dye, Lymphazurin blue dyeUndergo reverse mapping-guided axillary lymph node dissection | Procedure or surgery | Arm I (reverse mapping guided axillary lymph node dissection) |
| isosulfan blue based lymphatic mappingAlso: isosulfan blue dye, Lymphazurin blue dye | Drug | Arm I (reverse mapping guided axillary lymph node dissection), Arm II (control) |
| axillary lymph node dissectionAlso: isosulfan blue dye, Lymphazurin blue dyeUndergo standard axillary lymph node dissection | Procedure or surgery | Arm II (control) |
| quality-of-life assessmentAncillary studies | Procedure or surgery | Arm I (reverse mapping guided axillary lymph node dissection), Arm II (control) |
| Questionnaire administrationAncillary studies | Other | Arm I (reverse mapping guided axillary lymph node dissection), Arm II (control) |
Primary outcome
Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein
Time frame: Up to 4 years
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.
Percentage of Patients With Positive Axillary Reverse Mapping (ARM) Identified Nodes
Time frame: Up to 4 years
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.
Percentage of Patients With Lymphedema
Time frame: Up to 4 years
Difference between arms in patients developing lymphedema at any point during the study will be evaluated using chi-squared tests.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Chen, MD principal investigator
City of Hope Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing axillary lymph node dissection, isosulfan blue based lymphatic mapping and quality-of-life assessment in people with Breast Cancer, run by City of Hope Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein (time frame: Up to 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2017.