Sentinel Node Biopsy Alone or With Axillary Dissection After Primary Chemotherapy
- Conditions
- Breast Neoplasm Female
- Interventions
- Procedure: Sentinel Node BiopsyProcedure: Axillary Dissection
- Registration Number
- NCT04436809
- Lead Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Brief Summary
Many doctors believe that breast cancer patients scheduled for pre-operative chemotherapy whose cancer has spread to the axilla (determined by palpation plus ultrasound) should not receive sentinel node biopsy after chemotherapy, but proceed directly to removal of all the axillary lymph nodes.
In this study, breast cancer patients with operable medium-size cancer (T2) scheduled for pre-operative chemotherapy, and a disease-free or a metastatic axilla, are prospectively assigned to receive sentinel node biopsy as part of their post-chemotherapy surgical treatment (whose main aim is to remove the cancer in the breast).
Irrespective of whether the axilla is disease-free or metastatic before chemotherapy, if the removed sentinel nodes are disease-free on histological examination (pN0) after chemotherapy, then no further axillary treatment is given. If however the sentinel nodes contain cancer, then the other axillary lymph nodes will be removed surgically.
The study hypothesis is that, irrespective of whether the axilla is disease-free or metastatic before chemotherapy, patients with negative axillary sentinel nodes on histological examination (pN0) after chemotherapy, and who are no given further axillary treatment, will do as well as pN1 patients whose axillary lymph nodes are completely removed (a more aggressive treatment).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 353
- cT2 cN0/1 breast cancer
- Scheduled for neoadjuvant chemotherapy,
- Informed consent,
- Previous malignancy at another site
- Synchronous breast cancer at diagnosis
- Distant metastasis at diagnosis
- Clinically involved axilla (cN1) after neoadjuvant chemotherapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SNB only Sentinel Node Biopsy cT2 patients scheduled for primary chemotherapy (with or without a clinically involved axilla - cN0/1) who have disease-free sentinel nodes (pN0) after primary chemotherapy, are directed to "SNB only": i.e. no further treatment to the axilla. SNB + AD Sentinel Node Biopsy cT2 patients scheduled for primary chemotherapy (with or without a clinically involved axilla - cN0/1) who have metastatic sentinel nodes (pN1) on sentinel node biopsy (SNB) will undergo axillary dissection (AD) i.e. surgical removal of most axillary lymph nodes. SNB + AD Axillary Dissection cT2 patients scheduled for primary chemotherapy (with or without a clinically involved axilla - cN0/1) who have metastatic sentinel nodes (pN1) on sentinel node biopsy (SNB) will undergo axillary dissection (AD) i.e. surgical removal of most axillary lymph nodes.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) and Disease-Free Survival (DFS) Ten years DFS and OS are reckoned from date of surgery. DFS is time to recurrence or death, whichever occurred first. OS is time to death for any cause. Time is censored for living patients who are event-free at most recent follow up. OS and DFS curves are estimated using the Kaplan-Meier method and compared using the log-rank test. To compare DFS and OS in the SNB only and SNB + AD groups, propensity scores are estimated to account for bias due to non-random assignment to SNB vs SNB + AD
- Secondary Outcome Measures
Name Time Method Rate of axillary failure in those receiving only sentinel node biopsy Ten years In patients given only sentinel node biopsy the proportion of patients who develop disease in the axilla will be calculated.