Histology VABB-Histology Post Surgery Pilot Project (BETTY Trial) (BETTY)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Milan, Italy
- European Instituto of Oncology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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patient with radiological complete response
patient with radiological complete response after neoadjuvant chemotherapy
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patient with radiological complete response after neoadjuvant chemotherapy undergo to vacuum assisted breast biopsy and the to definitive surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of the accuracy of histological examination of the VABB performed pre-surgery
Time Frame: 45 days
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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
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45 days
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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 (Actual)
Study Record Updates
Last Update Posted (Actual)
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 0758/
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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