Intelligent Vacuum Assisted Biopsy Immediately Before Surgery As an Intra- or Pre-Operative Surrogate for Patient Response to Neoadjuvant Chemotherapy for Breast Cancer

Launched by KLINIK HIRSLANDEN, ZURICH · Feb 27, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help doctors better understand how well breast cancer patients respond to a treatment called neoadjuvant chemotherapy (NAC), which is given before surgery. In some cases, this treatment can completely eliminate the tumor, but doctors often can’t tell for sure if this has happened just by looking at imaging tests like MRIs. The trial aims to see if a special type of biopsy called vacuum-assisted biopsy (VAB), done before surgery, can more accurately detect any remaining cancer cells after NAC. By comparing the biopsy results to those obtained during surgery, researchers hope to improve the way we assess treatment effectiveness.

To participate in this trial, patients should be at least 18 years old and have a specific type of breast cancer that meets certain criteria, including having a tumor size between 1 and 5 cm. It's also important that the tumor is accessible for biopsy and that patients have had a good response to their chemotherapy, as shown in recent imaging tests. Participants can expect to undergo the VAB procedure and then have their results compared to the findings during surgery. It’s essential for potential participants to discuss their eligibility with their healthcare team, as there are specific conditions that might exclude them from joining the trial, such as having metastatic breast cancer or certain other types of breast cancer.

Gender

ALL

Eligibility criteria

• 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