Breast CancerBETTY-CRASYNCT06281210
Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery
A study testing Omission of surgical treatment in people with Breast Cancer and Triple Negative Breast Cancer, run by European Institute of Oncology at 2 sites in Italy.
Trial summary
This single arm study aims to evaluate the efficacy and safety of a non-surgical approach, consisting of radiotherapy (RT) alone, for patients who have achieved a complete pathological response (pCR) following neoadjuvant chemotherapy (NACT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Triple Negative Breast Cancer, HER2-positive Breast Cancer
- What is being tested?
- Omission of surgical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 2 sitesItaly
- Study dates
- 11 Dec 2023to 31 Dec 2028
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age> 18 years
- infiltrating breast carcinoma, non-special histotype, triple negative or HER2 +, T1-T2 N0
- single lesion
- neo-adjuvant chemotherapy treatment for at least 12 weeks according to clinical practice
- conservative surgery proposal
- M0
- tumour bed identified by breast markers placed in pre NACT by radiologist
Who cannot join
- Bilateral or multicentric tumour
- Presence of microcalcifications visualised on mammography
- Presence of associated DCIS
- Positive history of previous breast cancer
- Positive history of medical or psychiatric conditions preventing adherence to the protocol
- High risk patient
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Not yet recruiting
Istituto di Candiolo IRCCS
Candiolo, Turin, 10060
Antonio Toesca, MD
- Recruiting
European Institute of Oncology
Milan, 20141
Elisabetta Rossi, MD, +390294372191, ElisabettaMariaCristina.Rossi@ieo.it
Mara Negri, mara.negri@ieo.it
About this study
Official title: Non-inferiority Study in Patients With Complete Pathological Response After Neoadjuvant Chemotherapy and Negative VABB Biopsy Undergoing RT Alone, Omitting Surgical Treatment
This single arm study aims to evaluate the efficacy and safety of a non-surgical approach, consisting of radiotherapy (RT) alone, for patients who have achieved a complete pathological response (pCR) following neoadjuvant chemotherapy (NACT). The study design involves the histological confirmation of pCR using vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) guided by ultrasound. The primary objective is to demonstrate that the non-surgical, RT-only treatment and follow-up approach is not inferior to the traditional surgical approach in patients with pCR after NACT.
Read the detailed description
Neoadjuvant chemotherapy (NACT) in breast cancer is considered the \"gold standard\" for the treatment of locally advanced and inoperable malignancies.
In recent years, in view of the evidence gathered, it has also become a conventional treatment alternative for patients with operable disease who are possible candidates for adjuvant chemotherapy. NACT thus aims to reduce mortality and increase surgical options, while at the same time allowing in vivo chemosensitivity testing. In view of this, NACT represents the ideal setting for clinical and translational research, which nowadays also has to address the question of future treatment options.
It is indeed a source of lively debate whether chemotherapy should be considered the only possible treatment option for the patient.
This study falls into this context, the innovative aim of which is to demonstrate histologically with the use of VABB, the complete pathological response (pCR) and to avoid surgery.
The main aim of this study is to show that a non-surgical, radiotherapy-only treatment and follow-up approach is not inferior to a surgical approach for patients who have shown complete pathological response (pCR) following neoadjuvant chemotherapy (NACT), as confirmed through histological analysis of imaging-guided sampling.
Histology will be performed by sampling 4 grams of tissue by vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) by ultrasound guidance (on breast marker).
The hypothesis of the study is that the VAE/VABB will be used in patients with pCR at post-NACT imaging to demonstrate the absence of disease in the previous tumour bed and, accordingly, that the use of VAE/VABB with negative histology would lead to a gold standard of treatment without surgical overtreatment.
- Conditions
- Breast Cancer, Triple Negative Breast Cancer, HER2-positive Breast Cancer, Neoadjuvant Chemotherapy
- Being tested
- Omission of surgical treatment
- Keywords
- Triple negative breast cancer, HER2-positive breast cancer, neoadjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omission of surgical treatmentProcedure or surgery
Omission of surgery in patients with pCR after neoadjuvant chemotherapy and negative VABB biopsy
| Study group | Role | What they receive |
|---|---|---|
| Omission of surgical treatment | Experimental | Omission of surgical treatment in patients with complete pathological response after neoadjuvant chemotherapy and negative VABB biopsy Receives: Procedure: Omission of surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Absence of disease recurrence or progression, second primary tumor, or death
Measured: 5 years
Secondary outcomes (2)
Positive predictive value of MRI
Evaluation of the accuracy of breast MRI in predicting pCR following NACT
Measured: 6 months
Contrast-Enhanced Mammography (CEM) positive predictive value
Evaluation of the accuracy of breast CEM in predicting pCR following NACT
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start11 Dec 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (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.
- 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
- 77 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
- NCT06281210
- Sponsor's protocol ID
- IEO 2034
- Acronym
- BETTY-CRASY
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 28 Feb 2024
- 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 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Study in Patients With Complete Pathological Response After Neoadjuvant Chemotherapy and Negative VABB Biopsy Undergoing RT Alone, Omitting Surgical Treatment
- ClinicalTrials.gov ID
- NCT06281210
- Acronym / sponsor ID
- BETTY-CRASY / IEO 2034
- Conditions
- Breast Cancer, Triple Negative Breast Cancer, HER2-positive Breast Cancer, Neoadjuvant Chemotherapy
- Keywords
- Triple negative breast cancer, HER2-positive breast cancer, neoadjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Feb 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.
This single arm study aims to evaluate the efficacy and safety of a non-surgical approach, consisting of radiotherapy (RT) alone, for patients who have achieved a complete pathological response (pCR) following neoadjuvant chemotherapy (NACT). The study design involves the histological confirmation of pCR using vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) guided by ultrasound. The primary objective is to demonstrate that the non-surgical, RT-only treatment and follow-up approach is not inferior to the traditional surgical approach in patients with pCR after NACT.
Detailed description
Neoadjuvant chemotherapy (NACT) in breast cancer is considered the \"gold standard\" for the treatment of locally advanced and inoperable malignancies.
In recent years, in view of the evidence gathered, it has also become a conventional treatment alternative for patients with operable disease who are possible candidates for adjuvant chemotherapy. NACT thus aims to reduce mortality and increase surgical options, while at the same time allowing in vivo chemosensitivity testing. In view of this, NACT represents the ideal setting for clinical and translational research, which nowadays also has to address the question of future treatment options.
It is indeed a source of lively debate whether chemotherapy should be considered the only possible treatment option for the patient.
This study falls into this context, the innovative aim of which is to demonstrate histologically with the use of VABB, the complete pathological response (pCR) and to avoid surgery.
The main aim of this study is to show that a non-surgical, radiotherapy-only treatment and follow-up approach is not inferior to a surgical approach for patients who have shown complete pathological response (pCR) following neoadjuvant chemotherapy (NACT), as confirmed through histological analysis of imaging-guided sampling.
Histology will be performed by sampling 4 grams of tissue by vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) by ultrasound guidance (on breast marker).
The hypothesis of the study is that the VAE/VABB will be used in patients with pCR at post-NACT imaging to demonstrate the absence of disease in the previous tumour bed and, accordingly, that the use of VAE/VABB with negative histology would lead to a gold standard of treatment without surgical overtreatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omission of surgical treatment | Experimental | Procedure: Omission of surgical treatmentOmission of surgical treatment in patients with complete pathological response after neoadjuvant chemotherapy and negative VABB biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age> 18 years
- infiltrating breast carcinoma, non-special histotype, triple negative or HER2 +, T1-T2 N0
- single lesion
- neo-adjuvant chemotherapy treatment for at least 12 weeks according to clinical practice
- conservative surgery proposal
Key exclusion criteria (6 listed)
- Bilateral or multicentric tumour
- Presence of microcalcifications visualised on mammography
- Presence of associated DCIS
- Positive history of previous breast cancer
- Positive history of medical or psychiatric conditions preventing adherence to the protocol
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 |
|---|---|---|
| Omission of surgical treatmentOmission of surgery in patients with pCR after neoadjuvant chemotherapy and negative VABB biopsy | Procedure or surgery | Omission of surgical treatment |
Primary outcome
Event-free survival
Time frame: 5 years
Absence of disease recurrence or progression, second primary tumor, or death
2 secondary outcomes
Positive predictive value of MRI
Time frame: 6 months
Contrast-Enhanced Mammography (CEM) positive predictive value
Time frame: 6 months
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 28 Feb 2024.
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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.
Elisabetta Rossi, MD principal investigator
European Institute of Oncology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omission of surgical treatment in people with Breast Cancer and Triple Negative Breast Cancer, run by European Institute of Oncology at 2 sites 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 6 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: looking for participants now, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Contact Elisabetta Rossi, MD (+39-0294372191, ElisabettaMariaCristina.Rossi@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (time frame: 5 years). 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 Feb 2024.