CTRI/2021/09/036397
Not Yet Recruiting
N/A
A prospective multicenter cohort study to evaluate different surgical methods of axillary staging (sentinel lymph node biopsy, targeted axillary dissection, axillary dissection) in clinically node-positive breast cancer patients treated with neoadjuvant chemotherapy
Prof Dr med Thorsten Khn0 sites0 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Health Condition 1: C506- Malignant neoplasm of axillary tail of breast
- Sponsor
- Prof Dr med Thorsten Khn
- Status
- Not Yet Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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