Vacuum-assisted BiopsyNeoVABNCT03876951
Evaluation of the Accuracy of Percutaneous Biopsy by Vacuum-assisted Biopsy (VAB) to Assess Pathological Complete Response in Patients With Clinical and Radiological Complete Response After Neoadjuvant Chemotherapy (NeoVAB)
A study testing Vacuum-assisted biopsy in people with Vacuum-assisted Biopsy, run by Centre Georges Francois Leclerc at 1 site in France.
Trial summary
Breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death in females in the world. Neoadjuvant chemotherapy (NAC) is increasingly used in patients with operable breast cancer to enhance the likelihood of breast conservation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vacuum-assisted Biopsy
- What is being tested?
- Vacuum-assisted biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 30 Aug 2019to 8 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient aged 18 years or older.
- Written informed consent provided.
- Triple negative or HER2-positive / ER-negative or HER2-positive / ER-positive breast tumours.
- Patients eligible for breast conservation after NAC.
- Patients with T2-T3 N0 invasive breast cancer initially treated by NAC to allow breast conservation, who have received a minimum of 6 cycles of adequate NAC +/- anti-HER2.
- Clinical complete response after NAC.
- Radiological (mammography, breast US, breast MRI) complete response after NAC.
- Patients predicted to be node-negative at treatment initiation.
Who cannot join
- Patient younger than 18 years old.
- Pregnant or breastfeeding women.
- Proven metastatic axillary or internal mammary chain lymph node involvement before NAC proven by biopsy or cytology.
- Bilateral breast cancer.
- Contraindication to MRI.
- Contraindication to breast conservation
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- Patients with a BRCA mutation or other autosomal dominant high-penetrance genetic predisposition to breast cancer.
- Patients with limitation of freedom or under guardianship
- Inability for psychological reasons
- Hypersensitivity to local anaesthesia
- Initial imaging showing ACR6 micro calcifications and/or ACR6 non-mass enhancement associated to the index lesion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Multicenter Pilot Study to Evaluate the Accuracy of Percutaneous Biopsy by Vacuum-assisted Biopsy (VAB) to Assess Pathological Complete Response in Patients With Clinical and Radiological Complete Response After Neoadjuvant Chemotherapy (NeoVAB)
Breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death in females in the world. Neoadjuvant chemotherapy (NAC) is increasingly used in patients with operable breast cancer to enhance the likelihood of breast conservation. New generation of treatments or combinations lead to a high rate of pathological complete responses (pCR) in patients with human epidermal growth factor receptor 2 positive (HER2) and triple negative tumours. Safe omission of surgery in patients who receive NAC and achieve radiologic complete response depends on the ability to accurately estimate pCR preoperatively.
If pathological complete response after NAC could be accurately assessed by VAB, surgery could be avoided. In the context of new treatments or combinations with an increased pCR rate, this new strategy could induce major changes in clinical practice, leading to breast surgery de-escalation.
Read the detailed description
A total of 66 patients will be submitted to percutaneous vacuum-assisted biopsy (VAB), followed by breast surgery. The primary endpoint of the study is the false negative rate of VAB procedure. This rate will be calculated by comparing the detection of invasive or in situ carcinoma on surgical specimen versus VAB samples. The secondary endpoints of the study are feasibility, VAB procedure technical complications and safety.
- Conditions
- Vacuum-assisted Biopsy
- Being tested
- Vacuum-assisted biopsy
- Keywords
- breast cancer, neoadjuvant chemotherapy, vacuum-assisted biopsy, pathological complete response
- 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 biopsyDiagnostic test
Patients will be submitted to percutaneous vacuum-assisted biopsy (VAB), followed by breast surgery.
| Study group | Role | What they receive |
|---|---|---|
| vacuum-assisted biopsy | Experimental | Patients will be submitted to percutaneous vacuum-assisted biopsy (VAB), followed by breast surgery Receives: Diagnostic Test: Vacuum-assisted biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
False negative rate of vacuum-assisted biopsy
Absence of invasive and in-situ carcinoma on vacuum-assisted biopsy but presence of invasive or in-situ carcinoma on the surgical specimen.
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start30 Aug 2019
- Primary completion28 Feb 2025 (estimated)
- Study completion8 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vacuum-assisted BiopsyStudies 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
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876951
- Sponsor's protocol ID
- NeoVAB
- Acronym
- NeoVAB
- Status last verified
- Feb 2025
- First submitted
- 14 Mar 2019
- Last updated
- 17 Feb 2025
- 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 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Pilot Study to Evaluate the Accuracy of Percutaneous Biopsy by Vacuum-assisted Biopsy (VAB) to Assess Pathological Complete Response in Patients With Clinical and Radiological Complete Response After Neoadjuvant Chemotherapy (NeoVAB)
- ClinicalTrials.gov ID
- NCT03876951
- Acronym / sponsor ID
- NeoVAB / NeoVAB
- Conditions
- Vacuum-assisted Biopsy
- Keywords
- breast cancer, neoadjuvant chemotherapy, vacuum-assisted biopsy, pathological complete response
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 8 Apr 2025 (estimated)
- First posted
- 15 Mar 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.
Breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death in females in the world. Neoadjuvant chemotherapy (NAC) is increasingly used in patients with operable breast cancer to enhance the likelihood of breast conservation. New generation of treatments or combinations lead to a high rate of pathological complete responses (pCR) in patients with human epidermal growth factor receptor 2 positive (HER2) and triple negative tumours. Safe omission of surgery in patients who receive NAC and achieve radiologic complete response depends on the ability to accurately estimate pCR preoperatively.
If pathological complete response after NAC could be accurately assessed by VAB, surgery could be avoided. In the context of new treatments or combinations with an increased pCR rate, this new strategy could induce major changes in clinical practice, leading to breast surgery de-escalation.
Detailed description
A total of 66 patients will be submitted to percutaneous vacuum-assisted biopsy (VAB), followed by breast surgery. The primary endpoint of the study is the false negative rate of VAB procedure. This rate will be calculated by comparing the detection of invasive or in situ carcinoma on surgical specimen versus VAB samples. The secondary endpoints of the study are feasibility, VAB procedure technical complications and safety.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vacuum-assisted biopsy | Experimental | Diagnostic Test: Vacuum-assisted biopsyPatients will be submitted to percutaneous vacuum-assisted biopsy (VAB), followed by breast surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient aged 18 years or older.
- Written informed consent provided.
- Triple negative or HER2-positive / ER-negative or HER2-positive / ER-positive breast tumours.
- Patients eligible for breast conservation after NAC.
- Patients with T2-T3 N0 invasive breast cancer initially treated by NAC to allow breast conservation, who have received a minimum of 6 cycles of adequate NAC +/- anti-HER2.
Key exclusion criteria (11 listed)
- Patient younger than 18 years old.
- Pregnant or breastfeeding women.
- Proven metastatic axillary or internal mammary chain lymph node involvement before NAC proven by biopsy or cytology.
- Bilateral breast cancer.
- Contraindication to MRI.
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 biopsyPatients will be submitted to percutaneous vacuum-assisted biopsy (VAB), followed by breast surgery. | Diagnostic test | vacuum-assisted biopsy |
Primary outcome
False negative rate of vacuum-assisted biopsy
Time frame: During the surgery
Absence of invasive and in-situ carcinoma on vacuum-assisted biopsy but presence of invasive or in-situ carcinoma on the surgical specimen.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
Related trials for Vacuum-assisted Biopsy
Not yet recruiting
Percutaneous Biopsy After Neoadjuvant Chemotherapy.
Breast Cancer
Not yet recruiting
A Prospective Randomized Controlled Study on Minimally Invasive Breast Effects Between the Modified Local Compression Bandaging Method and the Traditional Whole Breast Compression Bandaging Method
Minimally Invasive Mammary Gland Vacuum-Assisted Biopsy
Recruiting
Omission of Breast Surgery for Breast Cancer Patients With pCR on MRI and Vacuum-assisted Biopsy After NST (OPTIMIST)
Breast Cancer Invasive
Recruiting
Refusal of Breast Surgery in Patients With Breast Cancer With a Clinical Complete Response (cCR) After Neoadjuvant Systemic Therapy and a Confirmed Pathological Complete Response (pCR) Using Vacuum-assisted Biopsy (VAB) and Sentinel Lymph Node Biopsy (SLNB)
Refusal of Breast Surgery in Patients With Breast Cancer With a cCR After NST and a Confirmed Pathological Complete Response (pCR) Using VAB and SLNB
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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Vacuum-assisted Biopsy, run by Centre Georges Francois Leclerc at 1 site in France.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
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?
False negative rate of vacuum-assisted biopsy (time frame: During the surgery). 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 Feb 2025.