A prospective multicenter study to evaluate different surgical methods of axillary staging in clinically node-positive breast cancer patients treated with neoadjuvant chemotherapy
- Conditions
- Health Condition 1: C506- Malignant neoplasm of axillary tail of breast
- Registration Number
- CTRI/2021/09/036397
- Lead Sponsor
- Prof Dr med Thorsten Khn
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method