Intelligent Vacuum Assisted Biopsy Immediately Before Surgery As an Intra- or Pre-Operative Surrogate for Patient Response to Neoadjuvant Chemotherapy for Breast Cancer
This study is for people with breast cancer who have had chemotherapy before surgery. Sometimes, chemotherapy makes the cancer shrink a lot, but it's hard to be sure if all the cancer cells are gone without surgery. This trial uses a special type of biopsy, called a vacuum-assisted biopsy (VAB), guided by ultrasound or mammogram. The aim is to see if this biopsy, taken just before surgery, can accurately find any remaining cancer cells. If successful, this could help doctors understand how well chemotherapy worked and potentially guide future treatment decisions, possibly even avoiding some surgeries in the future if a patient has responded very well.
At a glance
What is this study about?
When someone has breast cancer, doctors sometimes give chemotherapy before surgery. This is called neoadjuvant chemotherapy. The goal is to shrink the tumour, making surgery easier or even allowing for less extensive surgery. For many people, this chemotherapy works very well, and the tumour may even disappear completely on scans. However, even if scans look clear, it's very difficult to be 100% sure that all cancer cells are gone without actually operating and looking at the tissue under a microscope.
This study is testing a special type of biopsy, called a vacuum-assisted biopsy (VAB). This procedure uses a small needle and gentle suction to take several tiny samples of tissue from the area where the tumour used to be. It's guided by imaging like ultrasound or mammograms, to make sure the samples are taken from the right spot. The main idea is to see if this VAB can accurately tell us if any cancer cells are still present after chemotherapy, even when scans look clear.
Researchers will compare the results from the VAB taken just before surgery with what they find when the actual surgery is done. By doing this comparison, they hope to learn if the VAB is a reliable way to check how well the chemotherapy worked. If it is, this could eventually help doctors make more informed decisions for patients, potentially leading to more personalised treatment plans in the future.
Key takeaways
- This study evaluates a special biopsy (VAB) to check chemotherapy's effectiveness.
- It's for breast cancer patients who had chemotherapy before surgery and show a good response.
- The VAB aims to find any remaining cancer cells before surgery.
- Results from the VAB will be compared with actual surgery findings.
- The goal is to improve how doctors predict chemotherapy response for future patients.
Who may be eligible?
This study is generally for adults (18 or older) who have been diagnosed with a specific type of invasive breast cancer. Your tumour would have been between 1 and 5 cm in size and had a tiny clip placed in it before you started your chemotherapy. You must have had chemotherapy for your breast cancer, and after the chemotherapy, scans (like an MRI or ultrasound) should show that your tumour has either completely disappeared or is very, very small.
Crucially, the area where your tumour used to be must be easy to reach for the biopsy procedure. You should also be well enough to have breast cancer surgery. It's okay if you've had other cancers treated in the past, as long as they aren't expected to cause problems with this study.
You won't be able to join if your breast cancer has spread to other parts of your body, or if you have certain types of breast cancer like inflammatory breast cancer or very large microcalcifications. You also can't have obvious signs of cancer remaining on your scans after chemotherapy, or if you've had any surgery or radiotherapy to the affected breast before starting this trial.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a specific type of invasive breast cancer that was between 1cm and 5cm?
- Have you had chemotherapy for your breast cancer?
- Do your scans show that your tumour has mostly or completely disappeared after chemotherapy?
- Is the area where your tumour was easy for a doctor to get to for a biopsy?
- Are you planning to have breast surgery after your chemotherapy?
What does participation involve?
If you decide to take part in this study, the main step involves a special biopsy called a vacuum-assisted biopsy (VAB). This biopsy will be performed shortly before you have your planned breast surgery. During the VAB, doctors will use ultrasound or mammography to guide a needle to the area where your breast tumour used to be, to collect small tissue samples. This procedure is usually done in an outpatient setting.
After the VAB, you will go on to have your planned breast surgery as normal. The tissue samples collected during your VAB will then be carefully compared with the tissue removed during your surgery to see how accurate the VAB was in identifying any remaining cancer cells. You won't need any extra hospital visits or medication specifically for this study beyond your standard care. The total duration of your participation in the study itself will be from the time you have your VAB until the results from your surgery are available for comparison.
Potential risks and benefits
Locations (26)
- Universitätsspital SalzburgVerified postcodeSalzburg, Austria· Not yet recruiting
- Brustzentrum SchwazVerified postcodeSchwaz, Austria· Recruiting
- St. Josef Krankenhaus WienVerified postcodeVienna, Austria· Recruiting
- Agaplesion Markus KrankenhausVerified postcodeFrankfurt, Germany· Recruiting
- Brustzentrum HeidelbergVerified postcodeHeidelberg, Germany· Recruiting
- UFK Klinikum Südstadt RostockVerified postcodeRostock, Germany· Recruiting
- Helios Universitätsklinikum WuppertalVerified postcodeWuppertal, Germany· Recruiting
- Tumor Zentrum AarauVerified postcodeAarau, Switzerland· Recruiting
- Kantonsspital BadenVerified postcodeBaden, Switzerland· Recruiting
- Universitätsspital BaselVerified postcodeBasel, Switzerland· Recruiting
- Bethesda SpitalVerified postcodeBasel, Switzerland· Recruiting
- St. ClaraspitalVerified postcodeBasel, Switzerland· Recruiting
Common questions
What is neoadjuvant chemotherapy?
It's chemotherapy given before surgery to shrink the breast tumour and make surgery easier or more effective.
What is a vacuum-assisted biopsy (VAB)?
It's a procedure using a special needle and gentle suction to collect multiple small tissue samples from a specific area, guided by imaging.
Will I still need surgery if I take part in this study?
Yes, you will still have your planned breast surgery as part of your standard care, as the VAB results are compared to the surgery results.
What kind of breast cancer is this study for?
It's for specific types of invasive breast cancer between 1cm and 5cm, where scans show a very good response to chemotherapy.
Will I get extra medication in this study?
No, you won't receive any extra medication specifically for this study. Your treatment will be your standard care plus the VAB procedure.
How to find out more
Daniel Tschopp
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.