Breast CancerMINIVABNCT04107636
Minimal Invasive Breast Cancer Excision Using Vacuum Assisted Biopsy Under Ultrasound Guidance
A study testing Vacuum assisted biopsy and conventional lumpectomy in people with Breast Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Vacuum assisted biopsy and conventional lumpectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Aug 2021to 3 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female sex.
- 18 years or older.
- US visible breast cancer.
- Histologically proven non-lobular invasive breast carcinoma with maximum diameter of 15 mm as assessed by US.
- Willing and able to undergo preoperative breast MRI
- Able to fill out the questionnaire
- Able to provide informed consent.
Who cannot join
- Male sex.
- 17 years or younger.
- No proven invasive breast cancer.
- Poor US visibility of the breast cancer.
- Neoadjuvant therapy.
- Contra-indications to breast MRI or intravenous contrast administration.
Show all 11Show fewer
- Unable to fill out the questionnaire
- Unable to provide informed consent.
- Patients with breast implants.
- Pregnancy.
- Presence of additional malignant lesions at ipsilateral site on MRI.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- Vacuum assisted biopsy, conventional lumpectomy
- Keywords
- Minimal invasive, Biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum assisted biopsyProcedure or surgery
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.
conventional lumpectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Assigned Interventions | Experimental | 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. Receives: Procedure: Vacuum assisted biopsy; Procedure: conventional lumpectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of successful complete tumor excision by the VAB system
Successful is defined as 'having no residual (in situ) cancer in the surgical specimen'.
Measured: Through study completion, an average of two months
Secondary outcomes (6)
Incidence of successful complete resection of the tumor based upon imaging related features using a questionnaire 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 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.
Measured: 2 years
Incidence of successful complete resection of the tumor based upon patient related features using a questionnaire filled in by the patient.
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.
Measured: 2 years
Incidence of successful complete resection of the tumor based upon histopathological features from the large core biopsy specimens using a questionnaire 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 large core biopsy specimen (a.o. type of cancer, vascular invasion, receptor status, grade). The questionnaire will be filled in by a pathologist.
Measured: 2 years
Incidence of successful complete resection of the tumor based upon histopathological features from the VAB specimens using a questionnaire 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.
Measured: 2 years
Incidence of successful complete resection of the tumor based upon histopathological features from the surgical specimens using a questionnaire 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.
Measured: 2 years
Analyze the difference in quality-of-life and pain experience between VAB excision and surgery.
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start2 Aug 2021
- Primary completion3 Nov 2025
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Canisius-Wilhelmina Hospital, The Netherlands Cancer Institute, St. Antonius Hospital
- Responsible party
- Sponsor
- Investigators
- Ritse Mann, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107636
- Sponsor's protocol ID
- NL68820.091.19
- Acronym
- MINIVAB
- Status last verified
- May 2026
- First submitted
- 13 Jun 2019
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Invasive Breast Cancer Excision Using Vacuum Assisted Biopsy Under Ultrasound Guidance
- ClinicalTrials.gov ID
- NCT04107636
- Acronym / sponsor ID
- MINIVAB / NL68820.091.19
- Conditions
- Breast Cancer
- Keywords
- Minimal invasive, Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Canisius-Wilhelmina Hospital, The Netherlands Cancer Institute, St. Antonius Hospital
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assigned Interventions | Experimental | Procedure: Vacuum assisted biopsy, Procedure: conventional lumpectomyFirst, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female sex.
- 18 years or older.
- US visible breast cancer.
- Histologically proven non-lobular invasive breast carcinoma with maximum diameter of 15 mm as assessed by US.
- Willing and able to undergo preoperative breast MRI
Key exclusion criteria (11 listed)
- Male sex.
- 17 years or younger.
- No proven invasive breast cancer.
- Poor US visibility of the breast cancer.
- Neoadjuvant therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vacuum assisted biopsyFirst, 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. | Procedure or surgery | Assigned Interventions |
| conventional lumpectomyAfter 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. | Procedure or surgery | Assigned Interventions |
Primary outcome
Frequency of successful complete tumor excision by the VAB system
Time frame: Through study completion, an average of two months
Successful is defined as 'having no residual (in situ) cancer in the surgical specimen'.
6 secondary outcomes
Incidence of successful complete resection of the tumor based upon imaging related features using a questionnaire filled in by a radiologist.
Time frame: 2 years
Incidence of successful complete resection of the tumor based upon patient related features using a questionnaire filled in by the patient.
Time frame: 2 years
Incidence of successful complete resection of the tumor based upon histopathological features from the large core biopsy specimens using a questionnaire filled in by a pathologist.
Time frame: 2 years
Incidence of successful complete resection of the tumor based upon histopathological features from the VAB specimens using a questionnaire filled in by a pathologist.
Time frame: 2 years
Incidence of successful complete resection of the tumor based upon histopathological features from the surgical specimens using a questionnaire filled in by a pathologist.
Time frame: 2 years
Analyze the difference in quality-of-life and pain experience between VAB excision and surgery.
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ritse Mann, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum assisted biopsy and conventional lumpectomy in people with Breast Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of successful complete tumor excision by the VAB system (time frame: Through study completion, an average of two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.