Breast CancerBETTYNCT04365803
Histology VABB-Histology Post Surgery Pilot Project (BETTY Trial)
An observational study of Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial summary
Pilot study on patients with invasive ductal breast cancer triple negative or receptor tyrosine-protein kinase erbB-2 (HER2) overexpressed, any axillary lymphnodes status (any cN), candidates to neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- vacuum-assisted breast biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2018to 31 Dec 2023
- Phase
- Observational
- 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 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with triple negative or HER2 over-expressed breast cancer with radiological complete response after neoadjuvant chemotherapy
Who may be able to join
- age ≥ 18 aa;
- histological diagnosis done at European Institute of Oncology (if not, to does revision of pathological material);
- invasive ductal breast cancer triple negative or HER2 overexpressed, any cN;
- neoadjuvant standard systemic treatment after surgery +/- trastuzumab;
- propose of conservative or demolitive surgery;
- M0
- cancer bed identified pre neoadjuvant chemotherapy by clip
Who cannot join
- multicentric or bilateral breast cancer
- mammography microcalcifications
- in situ breast carcinoma
- positive anamnesis for previous breast cancer
- positive anamnesis for medical or psychological conditions that prevent membership study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Histological VABB and Histological Post-surgery in Patient With Complete Pathological Response After Neoadjuvant Systemic Treatment: Pilot Study
Pilot study on patients with invasive ductal breast cancer triple negative or receptor tyrosine-protein kinase erbB-2 (HER2) overexpressed, any axillary lymphnodes status (any cN), candidates to neoadjuvant chemotherapy.
The principal endpoint of the study will be the accuracy of the result of the histological examination of the Vacuum- Assisted Breast Biopsy (VABB) performed pre-surgery in comparison to the result of the histological examination of the definitive surgical intervention in patients with radiological complete response at Magnetic resonance imaging (MRI) done after the end of neoadjuvant chemotherapy.
Read the detailed description
The study articulates in five phases:
Phase one: acquisition of the informed consent followed by positioning a clip into the cancer bed (by radiologist) if not already present; Phase two: after radiological confirmation of pathological Complete Response (pCR) done performing breast ultrasound, MRI and 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission tomography (18-FDG-PET) after neoadjuvant chemotherapy the patient becomes candidate to VABB pre surgery.
Phase three: the patient has VABB within 15 day from the term of neoadjuvant chemotherapy Phase four: definitive surgical intervention within 30 days from the end of the neoadjuvant chemotherapy Phase five: verification of correspondence between histology of VABB and definitive histology.
The study hypothesis is that VABB could be used in the patients with pCR to the imaging post-neoadjuvant chemotherapy to confirm sensibility and specificity of 18 FDG TC PET and breast MRI to show the absence of breast cancer.
The use of VABB with negative histology result could bring to a therapeutic gold standard without over surgical treatment
- Conditions
- Breast Cancer
- Being tested
- vacuum-assisted breast biopsy
- Keywords
- breast cancer, vacuum assisted breast 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 breast biopsyProcedure or surgery
patient with radiological complete response after neoadjuvant chemotherapy undergo to vacuum assisted breast biopsy and the to definitive surgery
| Study group | Role | What they receive |
|---|---|---|
| patient with radiological complete response | patient with radiological complete response after neoadjuvant chemotherapy Receives: Procedure: vacuum-assisted breast biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the accuracy of histological examination of the VABB performed pre-surgery
Identification of percentage of cases with correspondence between histology of VABB presurgery and histology of definitive surgery in patients with complete radiological response after neoadjuvant chemotherapy
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Jun 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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 European Institute of OncologyThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabetta Rossi, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365803
- Sponsor's protocol ID
- IEO 0758/
- Acronym
- BETTY
- Status last verified
- Jun 2023
- First submitted
- 24 Apr 2020
- Last updated
- 28 Jun 2023
- 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 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Histological VABB and Histological Post-surgery in Patient With Complete Pathological Response After Neoadjuvant Systemic Treatment: Pilot Study
- ClinicalTrials.gov ID
- NCT04365803
- Acronym / sponsor ID
- BETTY / IEO 0758/
- Conditions
- Breast Cancer
- Keywords
- breast cancer, vacuum assisted breast biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Apr 2020 (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.
Pilot study on patients with invasive ductal breast cancer triple negative or receptor tyrosine-protein kinase erbB-2 (HER2) overexpressed, any axillary lymphnodes status (any cN), candidates to neoadjuvant chemotherapy.
The principal endpoint of the study will be the accuracy of the result of the histological examination of the Vacuum- Assisted Breast Biopsy (VABB) performed pre-surgery in comparison to the result of the histological examination of the definitive surgical intervention in patients with radiological complete response at Magnetic resonance imaging (MRI) done after the end of neoadjuvant chemotherapy.
Detailed description
The study articulates in five phases:
Phase one: acquisition of the informed consent followed by positioning a clip into the cancer bed (by radiologist) if not already present; Phase two: after radiological confirmation of pathological Complete Response (pCR) done performing breast ultrasound, MRI and 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission tomography (18-FDG-PET) after neoadjuvant chemotherapy the patient becomes candidate to VABB pre surgery.
Phase three: the patient has VABB within 15 day from the term of neoadjuvant chemotherapy Phase four: definitive surgical intervention within 30 days from the end of the neoadjuvant chemotherapy Phase five: verification of correspondence between histology of VABB and definitive histology.
The study hypothesis is that VABB could be used in the patients with pCR to the imaging post-neoadjuvant chemotherapy to confirm sensibility and specificity of 18 FDG TC PET and breast MRI to show the absence of breast cancer.
The use of VABB with negative histology result could bring to a therapeutic gold standard without over surgical treatment
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with radiological complete response | – | Procedure: vacuum-assisted breast biopsypatient with radiological complete response after neoadjuvant chemotherapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with triple negative or HER2 over-expressed breast cancer with radiological complete response after neoadjuvant chemotherapy
Key inclusion criteria (7 listed)
- age ≥ 18 aa;
- histological diagnosis done at European Institute of Oncology (if not, to does revision of pathological material);
- invasive ductal breast cancer triple negative or HER2 overexpressed, any cN;
- neoadjuvant standard systemic treatment after surgery +/- trastuzumab;
- propose of conservative or demolitive surgery;
Key exclusion criteria (5 listed)
- multicentric or bilateral breast cancer
- mammography microcalcifications
- in situ breast carcinoma
- positive anamnesis for previous breast cancer
- positive anamnesis for medical or psychological conditions that prevent membership study
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 breast biopsypatient with radiological complete response after neoadjuvant chemotherapy undergo to vacuum assisted breast biopsy and the to definitive surgery | Procedure or surgery | patient with radiological complete response |
Primary outcome
Evaluation of the accuracy of histological examination of the VABB performed pre-surgery
Time frame: 45 days
Identification of percentage of cases with correspondence between histology of VABB presurgery and histology of definitive surgery in patients with complete radiological response after neoadjuvant chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
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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.
Elisabetta Rossi, MD principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
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 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: status not confirmed, as of the sponsor's last update on 28 Jun 2023. 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 Italy. 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?
Results are not available in the source record.
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?
Evaluation of the accuracy of histological examination of the VABB performed pre-surgery (time frame: 45 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 28 Jun 2023; AzTrials last refreshed its copy on 7 Nov 2026.