Breast Cancer
Conditions
Keywords
breast cancer, axillary mapping, lymphedema
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.
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.
Interventions
PROCEDUREaxillary lymph node dissection
Undergo reverse mapping-guided axillary lymph node dissection
DRUGisosulfan blue based lymphatic mapping
PROCEDUREquality-of-life assessment
Ancillary studies
OTHERQuestionnaire administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
\- Patients diagnosed with breast cancer with a planned axillary lymph node dissection planned for breast cancer
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein | 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 | 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 | Up to 4 years | Difference between arms in patients developing lymphedema at any point during the study will be evaluated using chi-squared tests. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection) Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.
axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection
isosulfan blue based lymphatic mapping
quality-of-life assessment: Ancillary studies | 18 |
| Arm II (Control) Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
isosulfan blue based lymphatic mapping
axillary lymph node dissection: Undergo standard axillary lymph node dissection
quality-of-life assessment: Ancillary studies
Questionnaire administration: Ancillary studies | 21 |
| Total | 39 |
Baseline characteristics
| Characteristic | Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection) | Arm II (Control) | Total |
|---|---|---|---|
| Age, Continuous | 52 years | 47 years | 50 years |
| Region of Enrollment United States | 18 participants | 21 participants | 39 participants |
| Sex: Female, Male Female | 18 Participants | 21 Participants | 39 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 18 | 15 / 21 |
| serious Total, serious adverse events | 1 / 18 | 1 / 21 |
Outcome results
Primary
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.
Time frame: Up to 4 years
Population: Because of early termination the study did not accrue the planned number of subjects.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection) | Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein | Blue Lymphatic Channels Seen | 9 Participants |
| Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection) | Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein | Blue Lymphatic Channels Not Seen | 2 Participants |
| Arm II (Control) | Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein | Blue Lymphatic Channels Seen | 10 Participants |
| Arm II (Control) | Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein | Blue Lymphatic Channels Not Seen | 4 Participants |
p-value: 0.45Fisher Exact
Primary
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.
Time frame: Up to 4 years
Population: Because of early termination the study did not accrue the planned number of subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection) | Percentage of Patients With Lymphedema | Lymphedema Present | 4 Participants |
| Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection) | Percentage of Patients With Lymphedema | Lymphedema Not Present | 14 Participants |
| Arm II (Control) | Percentage of Patients With Lymphedema | Lymphedema Present | 6 Participants |
| Arm II (Control) | Percentage of Patients With Lymphedema | Lymphedema Not Present | 14 Participants |
p-value: 0.59Chi-squared
Primary
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.
Time frame: Up to 4 years
Population: Because of early termination the study did not accrue the planned number of subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection) | Percentage of Patients With Positive Axillary Reverse Mapping (ARM) Identified Nodes | Blue Lymph Nodes Seen | 4 Participants |
| Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection) | Percentage of Patients With Positive Axillary Reverse Mapping (ARM) Identified Nodes | Blue Lymph Nodes Not Seen | 7 Participants |
| Arm II (Control) | Percentage of Patients With Positive Axillary Reverse Mapping (ARM) Identified Nodes | Blue Lymph Nodes Seen | 4 Participants |
| Arm II (Control) | Percentage of Patients With Positive Axillary Reverse Mapping (ARM) Identified Nodes | Blue Lymph Nodes Not Seen | 10 Participants |
p-value: 0.5Fisher Exact