Health Condition 1: C506- Malignant neoplasm of axillary tail of breast
Conditions
Interventions
None listed
Sponsors
Prof Dr med Thorsten Khn
Eligibility
Inclusion criteria
Inclusion criteria: Signed informed consent form - Primary invasive breast cancer (confirmed by core biopsy) - cN+ (confirmed by core biopsy/fine needle aspiration or presence of highly suspicious axillary node[s] on imaging) - In case a minimally invasive biopsy of axillary lymph node(s) has been performed and yielded a negative or inconclusive result, patients may be included if the final classification after imaging-pathology-correlation is cN+ - cT1-cT4c - Scheduled for neoadjuvant systemic therapy - Female / male patients >= 18 years old
Exclusion criteria
Exclusion criteria: Distant metastasis - Recurrent breast cancer - Inflammatory breast cancer - Extramammary breast cancer - Bilateral breast cancer - History of invasive breast cancer, DCIS or any other invasive cancer - Confirmed or suspected supraclavicular lymph node metastasis - Confirmed or suspected parasternal lymph node metastasis - Axillary surgery before NACT (e.g. SLNB or nodal sampling) - Pregnancy - Less than 4 cycles of NACT administered - Patients not suitable for surgical treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the 5-year invasive disease-free survival (iDFS) in cN+ â?? ycN0 patients treated with different axillary staging techniques (ALND, TAD, SLNB, TLNB)Evaluation of the 3-year axillary recurrence rate in cN+ â?? ycN0 patients treated with different axillary staging techniques (ALND, TAD, SLNB, TLNB) - Evaluation of quality of life and arm morbidity in patients treated with different axillary staging techniquesTimepoint: Evaluation of the 5-year invasive disease-free survival (iDFS) in cN+ â?? ycN0 patients treated with different axillary staging techniques (ALND, TAD, SLNB, TLNB)Evaluation of the 3-year axillary recurrence rate in cN+ â?? ycN0 patients treated with different axillary staging techniques (ALND, TAD, SLNB, TLNB) - Evaluation of quality of life and arm morbidity in patients treated with different axillary staging techniques | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the success rate of nodal staging using different axillary staging techniques Evaluation of the number of removed lymph nodes using different axillary staging techniques and their correlation to complications, arm morbidity and quality of life - Evaluation of the operating time as a surrogate parameter for surgical resources - Evaluation of the rate of patients with positive nodes according to the technique used (as a surrogate parameter for the FNR) Timepoint: 5 Years | — |
Countries
Germany, India
Contacts
Public ContactDr Geeta Kadayaprath
Max Super Speciality Hospital,A Unit of Balaji Medical & Diagnostic Research Centre)
Outcome results
None listed