Breast Cancer
Conditions
Brief summary
This is a pilot study at the National Cancer Institute (INT) of Milan evaluated the feasibility of selective axillary dissection (SAD) which preserved the lymphatic drainage of the arm. Lymph nodes draining the arm are identified following radiotracer injection and lymphoscintigraphy, a technique called axillary reverse mapping (ARM). SAD was found feasible in 75% of patients. Furthermore only 9% had BCRL after SAD compared to 33% after axillary lymph node dissection (ALND).
Detailed description
To evaluate the efficacy, safety and cost reduction of SAD compared to standard ALND, we propose a prospective 2-arm randomised trial. The control arm consists of patients randomized to ALND, the study arm consists of patients randomized to SAD.
Interventions
PROCEDURESELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)
PROCEDURECOMPLETE AXILLARY DISSECTION (ALND)
Sponsors
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The proposed study is a 2-arm (1:1 allocation) prospective randomised trial. The control arm consists of patients randomized to ALND, the study arm is patients randomized to SAD.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with operable breast cancer who are candidates for ALND, irrespective of the type of breast surgery performed or adjuvant treatments administered. * Patients who sign the informed consent form after explanation of trial aims by a senologist involved in the study. * Patients able to attend INT for regular follow-up as required by study protocol.
Exclusion criteria
* Massive axillary metastasis (N2 AJCC). * Previous surgery to controlateral axillary region. * Previous radiotherapy to ipsilateral or controlateral regional lymph nodes. * Non compliance with any inclusion criterion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare the occurrence of breast-cancer-related lymphoedema (BCRL) after selective axillary dissection (SAD) and after axillary lymph node dissection (ALND) | 36 months | For this purpose patients enrolled will receive a physical assessment one month after surgery, with evaluation at 6 and 12 months after surgery that includes oncological assessment, physical assessment, lymphoscintigraphy, and self-evaluation questionnaire to assess the presence BCRL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the selective axillary dissection (SAD) procedure by assessing the occurrence of axillary relapses during follow-up due to incomplete resection of axillary lymph nodes. | 36 months | to assess the potential for residual disease in the axilla after SAD by evaluating the status, in the ALND arm, of nodes that are spared and assess the occurrence of axillary relapses during follow-up due to incomplete resection of axillary lymph nodes. |
Other
| Measure | Time frame | Description |
|---|---|---|
| To compare costs in the axillary lymph node dissection (ALND) and selective axillary dissection (SAD) arms | 36 months | To compare costs in the ALND and SAD arms including: lymphoscintigraphy, time required for surgery, and treatments required for lymphedema during follow up. |
Countries
Italy
Outcome results
None listed