Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery (BETTY-CRASY)
Non-inferiority Study in Patients With Complete Pathological Response After Neoadjuvant Chemotherapy and Negative VABB Biopsy Undergoing RT Alone, Omitting Surgical Treatment
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elisabetta Rossi, MD
- Phone Number: +39-0294372191
- Email: ElisabettaMariaCristina.Rossi@ieo.it
Study Locations
-
-
-
Milan, Italy, 20141
- Recruiting
- European Institute of Oncology
-
Contact:
- Elisabetta Rossi, MD
- Phone Number: +390294372191
- Email: ElisabettaMariaCristina.Rossi@ieo.it
-
Contact:
- Mara Negri
- Email: mara.negri@ieo.it
-
Principal Investigator:
- Elisabetta Rossi, MD
-
-
Turin
-
Candiolo, Turin, Italy, 10060
- Not yet recruiting
- Istituto Di Candiolo Irccs
-
Contact:
- Antonio Toesca, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Omission of surgical treatment
Omission of surgical treatment in patients with complete pathological response after neoadjuvant chemotherapy and negative VABB biopsy
|
Omission of surgery in patients with pCR after neoadjuvant chemotherapy and negative VABB biopsy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Event-free survival
Time Frame: 5 years
|
Absence of disease recurrence or progression, second primary tumor, or death
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive predictive value of MRI
Time Frame: 6 months
|
Evaluation of the accuracy of breast MRI in predicting pCR following NACT
|
6 months
|
|
Contrast-Enhanced Mammography (CEM) positive predictive value
Time Frame: 6 months
|
Evaluation of the accuracy of breast CEM in predicting pCR following NACT
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elisabetta Rossi, MD, European Institute of Oncology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IEO 2034
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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