Vacuum Assisted Biopsy for Breast Cancer Assessment
Intelligent Vacuum Assisted Biopsy Immediately Before Surgery As an Intra- or Pre-Operative Surrogate for Patient Response to Neoadjuvant Chemotherapy for Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
420 (estimated)
Sponsor
Klinik Hirslanden, Zurich · Other
Who this trial is looking for
This trial is looking for patients with certain types of breast cancer who have received chemotherapy. Participants will undergo a specific biopsy method before surgery to check for any remaining cancer.
Are You a Good Fit for This Trial?
You may be able to join if
I have a confirmed diagnosis of invasive breast cancer.
I am 18 years old or older.
I have received neoadjuvant chemotherapy.
I have a complete or nearly complete response on my recent MRI.
I have a single tumor that is between 1 and 5 cm.
I have given my written consent to participate.
I can undergo the required biopsy in the area of my former tumor.
I am in good condition for breast cancer surgery.
You may not be able to join if
I have metastatic breast cancer.
I have multifocal or multicentric breast cancer.
I have inflammatory breast cancer.
I have luminal-A type breast cancer.
I have signs of residual disease in my breast after chemotherapy.
I have had any local treatment to my breast before this trial.
I have other serious health or psychological conditions that could interfere with the trial.
I have microcalcifications larger than 2 cm in or around my tumor.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Neoadjuvant chemotherapy (NAC) is common practice in the primary treatment of breast cancer, leading to a complete pathologic remission (pCR) of the tumor in more than 50% in aggressive tumor types. As NAC induces different response patterns, radiologic imaging is not sufficiently accurate in predicting residual disease. Because of this uncertainty, surgery is so far the only valid option to eithe…
Neoadjuvant chemotherapy (NAC) is common practice in the primary treatment of breast cancer, leading to a complete pathologic remission (pCR) of the tumor in more than 50% in aggressive tumor types. As NAC induces different response patterns, radiologic imaging is not sufficiently accurate in predicting residual disease. Because of this uncertainty, surgery is so far the only valid option to either ascertain complete response or to remove the complete residual disease.
Vacuum-assisted biopsy (VAB) with the possibility of obtaining tissue of the former tumor center could contribute more reliably to detect any residual tumor or respectively, rule out residual disease. Ultrasound (US) or mammographically (MG) guided VAB will be used in this trial in order to detect residual tumor lesions in patients with radiological complete response (rCR) after NAC. The investigators will evaluate the diagnostic accuracy of the post-NAC VAB sample in comparison to the sample obtained in open surgery.
Trial Locations
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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 al…
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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