No. | Recommendations/Statements | EG | LoE | Sources |
---|---|---|---|---|
4.5. | a) The specimens for the histological workup must be obtained by punch biopsy, vacuum biopsy or, in exceptional cases, by open excision biopsy. | A | 3a | 73 , 78 |
b) Imaging procedures which clearly show the lesion must be used to guide the biopsy. The choice of biopsy method must take the diagnostic certainty and the risk of side effects into account. The investigator must use suitable measures to ensure that the biopsy site can be found again (e.g. clip placement). |
EC | |||
c) If a sonographic correlate has been identified for a lesion detected primarily using mammography or MRI, sampling must be carried out with ultrasound-guided punch biopsy. | EC | |||
d) Stereotactic vacuum biopsy must be used if micro-calcifications are present without accompanying focal findings. | A | 2b | 79 | |
e) Vacuum biopsy should be used for mammography-guided or MRI-guided tissue biopsy. | EC | |||
f) The correlation between the histological findings and the clinically suspicious findings must be reviewed and documented for all biopsies. | EC | |||
g) If the histopathological results of a category 4 or 5 lesion on imaging which was representatively sampled are benign, an appropriate control imaging procedure should be carried out after 6 months. | EC | |||
h) Punch biopsy should primarily be used for the fine-tissue clarification of lymph nodes classified as suspicious on imaging. | A | 2a | 80 , 81 , 82 , 83 | |
i) After the target tissue has been clearly identified, ≥ 3 samples should be taken during interventional, preferably ultrasound-guided punch biopsy, using a punch biopsy needle with a diameter of ≤ 14 G. | B | 3b | 84 , 85 , 86 | |
j) In vacuum biopsies, ≥ 12 samples should be taken using a 10-G needle. If other needle diameters (between 8 G and 11 G) are used, the biopsied specimens obtained should result in an equivalent sample volume. | EC | |||
4.6. | Primary open diagnostic excision biopsy must only be carried out in exceptional cases. | A | 3a | 79 , 87 |
Pre-operative or intraoperative marking must be carried out using a method which can clearly show the lesion, particularly when investigating non-palpable lesions. Evidence of adequate resection must be provided intraoperatively by specimen radiography or specimen ultrasound. If MRI-guided marking is carried out, then a control MR must be carried out within 6 months if the benign lesion was histologically unspecific. |
EC | |||
When carrying out preoperative wire marking of a non-palpable finding, the wire must be located in the focal area and extend less than 1 cm beyond this area. If the wire does not penetrate the focal area, the distance between the wire and the edge of the focal area must be ≤ 1 cm. In patients with extensive focal findings, it may be useful to place several markings around the surgically relevant target volume. | EC | |||
The surgically resected material must be clearly topographically marked and sent to the pathologist without incising the sampled tissue material. | EC | |||
4.7. | Staging (of the lungs, liver, and skeleton) should be carried out in high-risk patients newly diagnosed with UICC stage II (and higher) breast cancer and in patients newly diagnosed with stage III or IV breast cancer without symptoms of metastasis. | B | 2a | 88 |
Staging based on imaging must be carried out in patients newly diagnosed with breast cancer and a clinical suspicion of metastasis. | A | 2a | 88 | |
Full-body staging should only be carried out in women with a high risk of metastasis (N+, >T2) and/or aggressive tumor biology (e.g.: Her2+, triple-negative), clinical signs, symptoms, and if systemic chemotherapy/antibody therapy is planned. Full-body staging should be done using a thoracic-abdominal CT scan and skeletal scintigraphy. | EC |