Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371989
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2024-03-26
Brief Title:
Vacuum Assisted Biopsy and Surgery Correlation in HER2 and TN Breast Cancer Subtypes MRI Responders After Neoadjuvant Therapy BISUCO TRIAL
Sponsor:
Hospital Universitario 12 de Octubre
Organization:
Hospital Universitario 12 de Octubre
Study Overview
Official Title:
Vacuum Assisted Biopsy and Surgery Correlation in HER2 and TN Breast Cancer Subtypes MRI Responders After Neoadjuvant Therapy BISUCO TRIAL
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BISUCO
Brief Summary:
BACKGROUND AND CURRENT STATUS
Advancements in neoadjuvant systemic treatments NST for HER2 positive and triple-negative TN breast cancer BC subtypes have led to high rates of pathologic complete response pCR raising questions about the necessity of subsequent surgery especially for those undergoing adjuvant radiotherapy While Magnetic Resonance Imaging MRI remains the most effective imaging technique for assessing neoadjuvant treatment response surgery is still required to confirm pCR in cases of almost complete or complete MRI response iCR To safely avoid surgery in these BC exceptional responders a technique with high negative predictive value is imperative
OBJECTIVE
This study aims to establish the diagnostic efficacy of image-guided vacuum-assisted biopsy VAB in assessing pathological complete response pCR after NST in HER2 positive or TN breast cancer subtypes particularly those showing post NST-MRI complete or almost complete response
METHODS
A prospective study was conducted at Hospital Universitario 12 de Octubre de Madrid from June 25 2018 to October 25 2029 Twenty-five patients with HER2-positive or TN operable invasive ductal carcinoma IDC BC subtype at stages cT1-3N0-2 undergoing primary NST and showing complete or almost complete response on post NST-MRI were enrolled Ultrasound or stereotactic-guided vacuum-assisted biopsy VAB of the previous clip and tumor bed area was performed before surgery VAB pathological results were compared with surgical pathological results to evaluate the diagnostic efficacy of predicting pCR with VAB after NST Pathological representativeness of the VAB sample was ensured pCR was defined as the absence of invasive ductal carcinoma and in situ ductal carcinoma
Advancements in neoadjuvant systemic treatments NST for HER2 positive and triple-negative TN breast cancer BC subtypes have led to high rates of pathologic complete response pCR raising questions about the necessity of subsequent surgery especially for those undergoing adjuvant radiotherapy While Magnetic Resonance Imaging MRI remains the most effective imaging technique for assessing neoadjuvant treatment response surgery is still required to confirm pCR in cases of almost complete or complete MRI response iCR To safely avoid surgery in these BC exceptional responders a technique with high negative predictive value is imperative
OBJECTIVE
This study aims to establish the diagnostic efficacy of image-guided vacuum-assisted biopsy VAB in assessing pathological complete response pCR after NST in HER2 positive or TN breast cancer subtypes particularly those showing post NST-MRI complete or almost complete response
METHODS
A prospective study was conducted at Hospital Universitario 12 de Octubre de Madrid from June 25 2018 to October 25 2029 Twenty-five patients with HER2-positive or TN operable invasive ductal carcinoma IDC BC subtype at stages cT1-3N0-2 undergoing primary NST and showing complete or almost complete response on post NST-MRI were enrolled Ultrasound or stereotactic-guided vacuum-assisted biopsy VAB of the previous clip and tumor bed area was performed before surgery VAB pathological results were compared with surgical pathological results to evaluate the diagnostic efficacy of predicting pCR with VAB after NST Pathological representativeness of the VAB sample was ensured pCR was defined as the absence of invasive ductal carcinoma and in situ ductal carcinoma
Detailed Description:
BACKGROUND AND CURRENT STATUS
Currently advancements in neoadjuvant systemic treatments NST for HER2 and TN triple-negative breast cancer BC subtypes achieve high rates of pathologic complete response pCR prompting questions about the necessity of subsequent surgery particularly for those undergoing adjuvant radiotherapy
Although MRI Magnetic Resonance Imaging is the most effective imaging technique for assessing neoadjuvant treatment response we continue need to do surgery to confirm pcR in almost MRI imaging complete response iCR and iCR
To safe avoiding surgery in this BC exceptional responders subtypes we need to find a high negative predictive value technique
OBJECTIVE
To establish the diagnostic efficacy of guided image vacuum-assisted biopsy VAB in assessing pathological complete response pCR after neoadjuvant systemic therapy NST in HER2 or Triple Negative TN breast cancer BC subtypes showing post NST-MRI complete or almost complete response
METHODS
A prospective study was conducted at a tertiary university hospital from March 2019 to October 2023 25 patients with HER2-positive or TN operable invasive ductal carcinoma IDC BC subtypes at stages cT1-3N0-2 undergoing primary neoadjuvant systemic therapy NST and showing complete or almost complete response on post NST-MRI were enrolled in the study
A 7G ultrasound or stereotactic guided vacuum-assisted biopsy VAB was performed of the previous clip marked tumour bed area before the surgery
Then a comparison of the VAB pathological results with the surgical pathological results to evaluate the diagnostic efficacy validity and safety of predicting residual carcinoma pathologic complete response pCR with VAB after NST was made
Pathological representativeness of the VAB sample is mandatory including only the cases with post treatment changes and pathological correlation of the bed tumour area
pCR was defined as the absence of invasive ductal carcinoma and in situ ductal carcinoma
The studys hypothesis aims to achieve a VAB Negative Predictive Value NPV to detect residual carcinoma over 90 Additionally accuracy sensitivity positive predictive value and specificity are calculated
Currently advancements in neoadjuvant systemic treatments NST for HER2 and TN triple-negative breast cancer BC subtypes achieve high rates of pathologic complete response pCR prompting questions about the necessity of subsequent surgery particularly for those undergoing adjuvant radiotherapy
Although MRI Magnetic Resonance Imaging is the most effective imaging technique for assessing neoadjuvant treatment response we continue need to do surgery to confirm pcR in almost MRI imaging complete response iCR and iCR
To safe avoiding surgery in this BC exceptional responders subtypes we need to find a high negative predictive value technique
OBJECTIVE
To establish the diagnostic efficacy of guided image vacuum-assisted biopsy VAB in assessing pathological complete response pCR after neoadjuvant systemic therapy NST in HER2 or Triple Negative TN breast cancer BC subtypes showing post NST-MRI complete or almost complete response
METHODS
A prospective study was conducted at a tertiary university hospital from March 2019 to October 2023 25 patients with HER2-positive or TN operable invasive ductal carcinoma IDC BC subtypes at stages cT1-3N0-2 undergoing primary neoadjuvant systemic therapy NST and showing complete or almost complete response on post NST-MRI were enrolled in the study
A 7G ultrasound or stereotactic guided vacuum-assisted biopsy VAB was performed of the previous clip marked tumour bed area before the surgery
Then a comparison of the VAB pathological results with the surgical pathological results to evaluate the diagnostic efficacy validity and safety of predicting residual carcinoma pathologic complete response pCR with VAB after NST was made
Pathological representativeness of the VAB sample is mandatory including only the cases with post treatment changes and pathological correlation of the bed tumour area
pCR was defined as the absence of invasive ductal carcinoma and in situ ductal carcinoma
The studys hypothesis aims to achieve a VAB Negative Predictive Value NPV to detect residual carcinoma over 90 Additionally accuracy sensitivity positive predictive value and specificity are calculated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None