Invasive Breast Carcinoma, Neoadjuvant Chemotherapy, Sentinel Lymph Node Biopsy (SLNB)
Conditions
Brief summary
This study will prospectively determine the feasibility and oncological safety of sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NACT) in inflammatory breast cancer patients traditionally considered ineligible for SLNB due to locally advanced cancer with skin/chest wall involvement (cT4d) and heavy nodal burden at presentation (cN1/N2). This study will also assess the identification rate of sentinel lymph-node (SLN) (using single tracer mapping) after NACT in this patient population. Finally, the study will determine the long-term outcome of such cohort.
Interventions
PROCEDURESLN identification using technetium-99m
SLN Biopsy after pre-surgery positive SLN visualization.
PROCEDURESLN intra-operatory identification with radioguided surgery
SLN biopsy after no pre-surgery SLN visualization using technetium-99m and intra-surgery SLN identification.
PROCEDUREAxillary Limph Node Dissection (ALND)
Axillary Limph Node Dissection (ALND) after no pre-surgery SLN visualization using technetium-99m and no intra-surgery SLN identification.
Sponsors
European Institute of Oncology
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients over 18 years of age with clinically and biopsy-proven stage IIIB cT4d cN0-2 M0 breast cancer as assessed by clinical exam and imaging * Patients receiving NACT and having a nodal complete clinical response (ycN0) as assessed by physical exam and imaging (ultrasound and PET) * Ability to understand and willingness to sign informed consent document and comply with study procedures
Exclusion criteria
* Patients with cN3 stage at diagnosis * Participants with stage IV (metastatic) breast cancer * Participants with positive contralateral axillary nodes identified on standard imaging studies (mammograpy, MRI, ultrasound) and cito-histologically ascertained * Patients with a prior history of ipsilateral breast cancer * Pregnant patients * Patients after NACT with persistent palpable axillary nodes, as assessed by physical exam, or with persistent pathological axillary nodes, as assessed by imaging * Patients not consenting to ALND
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative SLN identification rate. | 3 Months | Evaluation of the feasibility of SLNB in a selected cohort of IBC patients operated who responded to systemic NACT in the axillary nodes, achieving complete clinical response (ycN0). The feasibility of SLNB, defined as the intraoperative SLN identification rate, will be calculated as the proportion of patients with successfully identified intraoperative SLNs among the enrolled patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 5 years | OS will be defined as the time from surgery to death from any cause. |
| Disease-free survival (DFS) | 5 years. | DFS will be defined as the time from surgery to loco-regional recurrence, metastasis, other primary non-breast carcinomas, or death, whichever occurs first. |
| Distant recurrence-free survival (DRFS) | 5 years | DRFS will be defined as the time from surgery to distant recurrence or death from any cause, whichever occurs first. |
| Breast cancer-specific survival (BCSS) | 5 years | BCSS will be defined as the time from surgery to death due to breast cancer. |
Countries
Italy
Contacts
Primary ContactFrancesca Magnoni, MD
Outcome results
None listed