Intelligente Vakuum-assistierte Brustbiopsie vor einer Tumoroperation zur Feststellung des Erfolgs der vorgängigen Chemotherapie

Procedure: Vacuum assisted biopsy (VAB)

Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:

- Written informed consent according to ICH/GCP regulations before registration and
prior to any trial specific procedures

- unifocal, histologically confirmed invasive breast cancer with IHC luminal B (with
or without overexpression or amplification of the HER2 receptor) and all ER negative
(ER < 10%) breast cancers

- Initial tumor size larger than 1 and less than 5 cm (cT1c to cT2), any N, M0

- Clipping of the primary tumor center prior to the start of neo-adjuvant chemotherapy

- Neo-adjuvant chemotherapy resulting in a radiological complete response or near
complete response on MR-Imaging (confirmed within 28 days before or on registration)
as described in the trial specific MR-Imaging instructions (available on the welcome
page of the study specific SecuTrial link). MRI is strongly recommended, alternative
ultrasound

- Former tumor bed must be accessible for biopsy

- Female or male aged = 18 years

- Adequate condition for breast cancer surgery

- Patients with a previously treated malignancy are eligible, when the risk of the
prior malignancy interfering with either safety or efficacy endpoints is very low

Exclusion criteria:

- Metastatic breast cancer

- Multifocal/Multicentric breast cancer

- Inflammatory breast cancer

- Luminal-A types of breast cancers (ER = 10% and PgR = 10 % and G1 or 2, and/or Ki-67
= 20%, HER2 negative) or low risk if assessed by a validated genomic prognostic test
(e.g. Mammaprint, Endopredict, Oncotype or Nanostring)

- Distinct radiological sign of residual disease in the breast after neo-adjuvant
chemotherapy by imaging

- Intra-/peritumoral microcalcifications larger than 2 cm at time of diagnosis

- Any local therapy (irradiation or surgery) to the currently treated breast prior to
the trial intervention

- Any other serious underlying medical, psychiatric, psychological, familial or
geographical condition, which in the judgment of the investigator may interfere with
the planned staging, trial intervention and follow-up, affect patient compliance or
place the patient at high risk from trial intervention-related complications