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Anesthetics

First, the tumor will be removed under local anesthesia using the VAB system with US guidance, through a small skin incision (\<0.5 cm). A localization marker will be placed in the biopsy cavity, to help determine the cavity location. After 3 weeks, the breast conserving surgery is performed, excising the VAB excision cavity and a ≥1 cm of surrounding tissue, as deemed appropriate by the attending breast surgeon. A sentinel node biopsy will be performed in the same procedure.

First, the tumor will be removed under local anesthesia using the VAB system with US guidance, through a small skin incision (\<0.5 cm). A localization marker will be placed in the biopsy cavity, to help determine the cavity location.

Vacuum assisted biopsy

After 3 weeks, the breast conserving surgery is performed, excising the VAB excision cavity and a ≥1 cm of surrounding tissue, as deemed appropriate by the attending breast surgeon. A sentinel node biopsy will be performed in the same procedure.

conventional lumpectomy

Wendelien Sanderink, MSc

Ritse Mann, PhD

Ritse Mann, MD, PhD

This study will assess whether it is feasible to remove small breast cancers completely using the Vacuum Assisted Biopsy (VAB) system System under Ultrasound guidance.

Rationale: In the Netherlands, ≥7000 women undergo surgery for small breast cancers (T1) every year. In this study, the investigators will evaluate under which conditions it is possible to excise small breast cancers using the vacuum assisted biopsy (VAB) system under ultrasound (US) guidance. When successful, this can allow outpatient treatment of a selection of women with small breast cancers, improving the cosmetic outcome and quality of life.

Objective: Our study aim is to assess whether it is feasible to remove small breast cancers completely using the VAB system under US guidance.

Study design: This is a multi-centre, translational clinical phase II study in 170 women with cancers ≤15 mm based upon US and MRI measurements, and without mammographic or magnetic resonance imaging (MRI) evidence of more extensive disease (e.g. microcalcifications or non-mass enhancement).

Study population: Women with non-lobular invasive carcinomas, ≤15 mm based upon US and MRI measurements, no mammographic evidence of more extensive disease (e.g. microcalcifications or extensive architectural distortion), and sufficient space (roughly ≥6 mm, present or creatable by injection of saline) between the tumor and the dermis, nipple or pectoral muscle, are eligible for this study.

Intervention: In 170 women with cancers ≤15 mm based upon US and MRI measurements, and without mammographic evidence of more extensive disease (e.g. microcalcifications), after informed consent has been obtained, patients will be asked to fill out a questionnaire for assessment of breast cancer risk, using the Tyrer-Cuzick (or IBIS) model.

First, the tumor will be removed under local anesthesia using the VAB system with US guidance, through a small skin incision (\<0.5 cm). A localization marker will be placed in the biopsy cavity, to help determine the cavity location. After 3 weeks, the breast conserving surgery is performed, excising the VAB excision cavity and a ≥1 cm of surrounding tissue, as deemed appropriate by the attending breast surgeon. A sentinel node biopsy will be performed in the same procedure.

Main study parameters/endpoints: Main endpoint of the study is the incidence of successful complete tumor excision by the VAB system, where successful is defined as having no tumor foci beyond 1 cm from the edge of the VAB cavity in the surgical re-excision specimen.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Our approach allows testing the feasibility of an innovating approach to remove breast cancer, with minimal negative effects or possible complications.

The burden from this study to the participating patients is the fact that two procedures are mandatory. This will result in prolonged time from initial diagnosis to end of surgical treatment. Positive study outcomes can pave the way to minimal invasive treatment in a selection of women, presenting with small breast tumors.

Minimal Invasive Breast Cancer Excision Using Vacuum Assisted Biopsy Under Ultrasound Guidance

Successful is defined as 'having no residual (in situ) cancer in the surgical specimen'.

An analysis will be performed to identify predicting factors for underestimation and for complete excision of the lesion after VAB. Factors included in the analysis are imaging related features from mammography, ultrasound and MRI (a.o. breast density, lesion type, shape, (background) enhancement). The questionnaire will be filled in by a radiologist.

An analysis will be performed to identify predicting factors for underestimation and for complete excision of the lesion after VAB. Factors included in the analysis are patient related variables (a.o. age, body mass index, age at menarch, obstetric history, menopause status, history of a benign breast condition, history of ovarian cancer, use of hormone replacement therapy, family history). Patients will be asked to fill out a questionnaire for assessment of breast cancer risk, using the Tyrer-Cuzick (or IBIS) model.

An analysis will be performed to identify predicting factors for underestimation and for complete excision of the lesion after VAB. Factors included in the analysis are histopathological related features from the large core biopsy specimen (a.o. type of cancer, vascular invasion, receptor status, grade). The questionnaire will be filled in by a pathologist.

An analysis will be performed to identify predicting factors for underestimation and for complete excision of the lesion after VAB. Factors included in the analysis are histopathological related features from the VAB specimen (a.o. type of cancer, vascular invasion, receptor status, grade, tubular formation, mitotic count). The questionnaire will be filled in by a pathologist.

An analysis will be performed to identify predicting factors for underestimation and for complete excision of the lesion after VAB. Factors included in the analysis are histopathological related features from the surgical specimen (a.o. type of cancer, vascular invasion, receptor status, grade, tubular formation, mitotic count, tumor satellites). The questionnaire will be filled in by a pathologist.

In order to analyze the quality-of-life and differences in pain experience after VAE and surgery, patients will be asked to indicate a quality-of-life and pain experience score on the following time points:

* 1 week after the VAB procedure.
* 1 week following the surgical procedure.

The EORTC QLQ-C30 questionnaire will be used to measure quality-of-life. All of the scales range from 1 to 4 or 1 to 7. A high scale score represents a higher response level. Thus a high score for the quality-of-life represents a high quality-of-life.

Canisius-Wilhelmina Hospital

The Netherlands Cancer Institute

St. Antonius Hospital

Radboud University Medical Center

Image-guided biopsy of the tumor bed and coil area performed before surgery

Image guided VAB of tumor site. A needle is inserted into the affected tumor bed area using an US or stereotactic method to collect cells or tissue from a tumor mass.

Image guided vacuum assisted biopsy

sara jimenez arranz

BACKGROUND AND CURRENT STATUS:

Advancements in neoadjuvant systemic treatments (NST) for HER2 positive and triple-negative (TN) breast cancer (BC) subtypes have led to high rates of pathologic complete response (pCR), raising questions about the necessity of subsequent surgery, especially for those undergoing adjuvant radiotherapy. While Magnetic Resonance Imaging (MRI) remains the most effective imaging technique for assessing neoadjuvant treatment response, surgery is still required to confirm pCR in cases of almost complete or complete MRI response (iCR). To safely avoid surgery in these BC "exceptional responders," a technique with high negative predictive value is imperative.

OBJECTIVE:

This study aims to establish the diagnostic efficacy of image-guided vacuum-assisted biopsy (VAB) in assessing pathological complete response (pCR) after NST in HER2 positive or TN breast cancer subtypes, particularly those showing post NST-MRI complete or almost complete response.

METHODS:

A prospective study was conducted at "Hospital Universitario 12 de Octubre de Madrid" from June 25, 2018, to October 25, 2029. Twenty-five patients with HER2-positive or TN operable invasive ductal carcinoma (IDC) BC subtype, at stages cT1-3/N0-2 undergoing primary NST and showing complete or almost complete response on post NST-MRI, were enrolled. Ultrasound or stereotactic-guided vacuum-assisted biopsy (VAB) of the previous clip and tumor bed area was performed before surgery. VAB pathological results were compared with surgical pathological results to evaluate the diagnostic efficacy of predicting pCR with VAB after NST. Pathological representativeness of the VAB sample was ensured. pCR was defined as the absence of invasive ductal carcinoma and in situ ductal carcinoma.

BACKGROUND AND CURRENT STATUS:

Currently, advancements in neoadjuvant systemic treatments (NST) for HER2 and TN (triple-negative) breast cancer (BC) subtypes achieve high rates of pathologic complete response (pCR), prompting questions about the necessity of subsequent surgery, particularly for those undergoing adjuvant radiotherapy.

Although MRI (Magnetic Resonance Imaging) is the most effective imaging technique for assessing neoadjuvant treatment response we continue need to do surgery to confirm pcR in almost MRI imaging complete response (iCR) and iCR.

To safe avoiding surgery in this BC "exceptional responders" subtypes we need to find a high negative predictive value technique.

OBJECTIVE:

To establish the diagnostic efficacy of guided image vacuum-assisted biopsy (VAB) in assessing pathological complete response (pCR) after neoadjuvant systemic therapy (NST) in HER2 or Triple Negative (TN) breast cancer (BC) subtypes, showing post NST-MRI complete or almost complete response.

METHODS:

A prospective study was conducted at a tertiary university hospital from March 2019 to October 2023 25 patients with HER2-positive or TN operable invasive ductal carcinoma (IDC) BC subtypes, at stages cT1-3/N0-2 undergoing primary neoadjuvant systemic therapy (NST) and showing complete or almost complete response on post NST-MRI, were enrolled in the study.

A 7G ultrasound or stereotactic guided vacuum-assisted biopsy (VAB) was performed of the previous clip marked tumour bed area before the surgery.

Then a comparison of the VAB pathological results with the surgical pathological results to evaluate the diagnostic efficacy (validity and safety) of predicting residual carcinoma pathologic complete response (pCR) with VAB after NST was made.

Pathological representativeness of the VAB sample is mandatory including only the cases with post treatment changes and pathological correlation of the bed tumour area.

pCR was defined as the absence of invasive ductal carcinoma and in situ ductal carcinoma.

The study's hypothesis aims to achieve a VAB Negative Predictive Value (NPV) to detect residual carcinoma over 90%. Additionally, accuracy, sensitivity, positive predictive value, and specificity are calculated.

Vacuum Assisted Biopsy and Surgery Correlation in HER2 and TN Breast Cancer Subtypes MRI Responders After Neoadjuvant Therapy: BISUCO TRIAL

Ultrasound or stereotactic-guided vacuum-assisted biopsy (VAB) of the previous clip and tumor bed area was performed before surgery. VAB pathological results were compared with surgical pathological results to evaluate the NPV, PPV , specificity and sensibility of predicting pCR with VAB after NST

Hospital Universitario 12 de Octubre

* Unicentric histologically confirmed invasive luminal B, HER2- enriched, triple negative breast cancer + Clipping + Neoadjuvant chemotherapy
* rCR / near-rCR in MRI
* Registration
* US-guided VAB
* Breast conserving surgery / mastectomy
* Pathology examination 1. Preoperative VAB, 2. Surgical specimen

The trial intervention consists of a diagnostic interventional procedure, US-guided or mammographically guided VAB post-NAC, prior to the standard breast surgery.

Vacuum assisted biopsy (VAB)

Daniel Tschopp

Andreas Jakob, MD

Cornelia Leo, Prof

Christian Kurzeder, Prof

Dieter Müller, MD

Matthias Siebert, MD

Patrizia Sager, MD

Martina Gabriella Maranta, MD

Martina Maranta, MD

Mathias Fehr, Prof

Magdalena Kohlik, MD

Kathrin Schwedler, MD

Peter Dubsky, Prof

Maik Hauschild, MD

Christine Strub, MD

Michael Knauer, Prof

Daniela Hagen, MD

Christoph Tausch, MD

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.

Neoadjuvant chemotherapy (NAC), initially indicated to downstage tumors to achieve the option of breast conserving surgery, has lately become common practice in the primary treatment of breast cancer. The use of modern NAC regimens lead to a complete pathologic remission (pCR) of the tumor in more than 50% in aggressive tumor types.

In general, it is difficult to predict pCR in the absence of invasive surgical techniques, as it depends on several factors such as biological subtype, the used chemotherapy regimen and anatomic stage. The most common imaging methods beside clinical examination are breast ultrasound, mammography and breast magnetic resonance imaging (MRI). As NAC induces different response patterns, radiologic imaging is not sufficiently accurate in predicting residual disease. Because of this uncertainty, surgery (and the standardized assessment of resected tissue) 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.

The main objective of the trial is to determine the diagnostic accuracy of I-VAB using the full pathologic specimen evalutation obtained after open surgery to detect residual tissue.

multicenter, prospective, single arm, feasibility trial

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

Intelligent Vacuum Assisted Biopsy Immediately Before Surgery as an Intra- or Pre-Operative Surrogate for Patient Response to Neoadjuvant Chemotherapy for Breast Cancer (VISION I): A Multicenter Prospective Feasibility Trial

Sensitivity of I-VAB is defined as proportion of true positive patients (Both VAB and surgery showing non pCR) given patients with non pCR assessed using surgical specimen.

Specificity of I-VAB is defined as proportion of true negative patients (Both VAB and surgery showing pCR) given patients with pCR assessed using surgical specimen.

PPV of I-VAB is defined as proportion of true positive patients given patients with non pCR assessed using VAB

NPV of I-VAB is defined as proportion of true negative patients given patients with pCR assessed using VAB

ACC of I-VAB is defined as the proportion of true positive and true negative patients.

Surgical lymph node status (positive vs. negative) is categorized by the pathologist according to surgical specimen.

Proportion of patients with bleeding/hematoma causing immediate surgical intervention and breast infection, which are related to VAB.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Minimal Invasive Breast Cancer Excision Using Vacuum Assisted Biopsy Under Ultrasound Guidance	NCT04107636	Breast Cancer	Vacuum assisted... conventional lu...	18 Years -	Radboud University Medical Center
Vacuum Assisted Biopsy and Surgery Correlation in HER2 and TN Breast Cancer Subtypes MRI Responders After Neoadjuvant Therapy: BISUCO TRIAL	NCT06371989	Breast Cancer Breast Biopsy	Image guided va...	18 Years - 95 Years	Hospital Universitario 12 de Octubre
Vacuum Assisted Biopsy and Surgery Correlation in HER2 and TN Breast Cancer Subtypes MRI Responders After Neoadjuvant Therapy: BISUCO TRIAL	NCT06371989	Breast Cancer Breast Biopsy	Image guided va...	18 Years - 95 Years	Hospital Universitario 12 de Octubre
Minimal Invasive Breast Cancer Excision Using Vacuum Assisted Biopsy Under Ultrasound Guidance	NCT04107636	Breast Cancer	Vacuum assisted... conventional lu...	18 Years -	Radboud University Medical Center
Intelligent Vacuum Assisted Biopsy Immediately Before Surgery as an Intra- or Pre-Operative Surrogate for Patient Response to Neoadjuvant Chemotherapy for Breast Cancer	NCT04289935	Breast Cancer	Vacuum assisted...	18 Years -	Klinik Hirslanden, Zurich

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