Intelligent Vacuum-assisted Breast Biopsy Before Tumor Surgery to Determine the Success of Prior Chemotherapy

Breast Cancer

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Procedure: Vacuum assisted biopsy (VAB)

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Allocation: N/A. Intervention model: Sequential Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).

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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

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Sensitivity

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Specificity;Positive predictive value (PPV);Negative predictive value (NPV);Accuracy (ACC);Surgical lymph node status;Adverse events

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