Breast CancerBISUCONCT06371989
Vacuum Assisted Biopsy and Surgery Correlation in HER2 and TN Breast Cancer Subtypes MRI Responders After Neoadjuvant Therapy: BISUCO TRIAL
A study testing Image guided vacuum assisted biopsy in people with Breast Cancer and Breast Biopsy, run by Hospital Universitario 12 de Octubre at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 95 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Breast Biopsy
- What is being tested?
- Image guided vacuum assisted biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 11 Mar 2019to 20 Dec 2022
- 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 to 95 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18 years
- Biopsy-proven operable breast IDC non-otherwise specified (no other subtypes) with or without DCIS
- HER2-positive (score 3+ in immunohistochemistry or HER2 amplification in FISH) or TN subtypes as per immunohistochemistry
- Stages cT1-2/N0-2/M0
- Administration of standard complete neoadjuvant systemic treatment
- Complete or almost complete response on breast post NST-MRI
Who cannot join
- Uncompleted NST or non-operable breast carcinoma
- Associated suspicious microcalcifications on diagnostic mammogram measuring more than 20mm
- Proven multicentric or multifocal disease
- High-risk patients
- Personal history of breast cancer (ipsilateral or contralateral)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Breast Cancer, Breast Biopsy
- Being tested
- Image guided vacuum assisted biopsy
- Keywords
- Neoadjuvant response, Vacuum assisted 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.
Image guided vacuum assisted biopsyProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Image-Guided Vacuum assisted biopsy of Tumor Site | Experimental | Image-guided biopsy of the tumor bed and coil area performed before surgery Receives: Procedure: Image guided vacuum assisted biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The negative Predictive Value (NPV), Positive predictive value, specificity and sensibility of the VAB compared to Standard Surgery with Pathologic Evaluation
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
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start11 Mar 2019
- Primary completion20 Mar 2021
- Study completion20 Dec 2022
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.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sara jimenez arranz, Principal investigator, Hospital Universitario 12 de Octubre Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371989
- Sponsor's protocol ID
- 19/160
- Acronym
- BISUCO
- Status last verified
- Mar 2024
- First submitted
- 26 Mar 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vacuum Assisted Biopsy and Surgery Correlation in HER2 and TN Breast Cancer Subtypes MRI Responders After Neoadjuvant Therapy: BISUCO TRIAL
- ClinicalTrials.gov ID
- NCT06371989
- Acronym / sponsor ID
- BISUCO / 19/160
- Conditions
- Breast Cancer, Breast Biopsy
- Keywords
- Neoadjuvant response, Vacuum assisted biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hospital Universitario 12 de OctubreUniversity, hospital or other
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 20 Mar 2021 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 17 Apr 2024 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Image-Guided Vacuum assisted biopsy of Tumor Site | Experimental | Procedure: Image guided vacuum assisted biopsyImage-guided biopsy of the tumor bed and coil area performed before surgery |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients over 18 years
- Biopsy-proven operable breast IDC non-otherwise specified (no other subtypes) with or without DCIS
- HER2-positive (score 3+ in immunohistochemistry or HER2 amplification in FISH) or TN subtypes as per immunohistochemistry
- Stages cT1-2/N0-2/M0
- Administration of standard complete neoadjuvant systemic treatment
Key exclusion criteria (5 listed)
- Uncompleted NST or non-operable breast carcinoma
- Associated suspicious microcalcifications on diagnostic mammogram measuring more than 20mm
- Proven multicentric or multifocal disease
- High-risk patients
- Personal history of breast cancer (ipsilateral or contralateral)
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 |
|---|---|---|
| Image guided vacuum assisted biopsyImage 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. | Procedure or surgery | Image-Guided Vacuum assisted biopsy of Tumor Site |
Primary outcome
The negative Predictive Value (NPV), Positive predictive value, specificity and sensibility of the VAB compared to Standard Surgery with Pathologic Evaluation
Time frame: 15 days
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
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 17 Apr 2024.
- Individual participant dataSharing planned: Yes
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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.
sara jimenez arranz principal investigator
Hospital Universitario 12 de Octubre Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image guided vacuum assisted biopsy in people with Breast Cancer and Breast Biopsy, run by Hospital Universitario 12 de Octubre at 1 site in Spain.
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 6 inclusion and 5 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 17 Apr 2024. 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 Spain. 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?
The negative Predictive Value (NPV), Positive predictive value, specificity and sensibility of the VAB compared to Standard Surgery with Pathologic Evaluation (time frame: 15 days). 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 17 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.