Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05846997
Status:
RECRUITING
Last Update Posted:
2023-05-06
First Post:
2023-03-24
Brief Title:
Use of INnovative and Micro-INvasive TEchniques for the Early Identification of Breast Cancer Patients Benefitting From Neo-adjuvant Therapy
Sponsor:
Centro di Riferimento Oncologico - Aviano
Organization:
Centro di Riferimento Oncologico - Aviano
Study Overview
Official Title:
Use of INnovative and Micro-INvasive TEchniques for the Early Identification of Breast Cancer Patients Benefitting From Neo-adjuvant Therapy
Status:
RECRUITING
Status Verified Date:
2023-04
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:
INTENT
Brief Summary:
The purpose of the study is the identification of novel micro-invasive predictors of pathological complete response pCR during neo-adjuvant therapy
Detailed Description:
This is a single arm prospective monocentric open experimental pilot study The response to NAC in breast cancer is extremely heterogeneous The study and the identification of factors that can predict the response to treatment is therefore a priority constituting a relevant clinical unmet needModern molecular biology techniques as well as imaging diagnostics could be valuable tools for characterizing the response to NAC toward the definition of more personalized therapiesThe prediction of therapy response after two cycle of chemotherapy rather than at the end of six cycles using non-invasive procedures will spare unwanted toxicity to the patients and resources to the Regional and National Health system This study will also provide the patients their familiar and all the stakeholders involved in the cure of Breast Cancer new important information regarding the management of breast cancer patientsThis is a non-interventional study therefore the treatment will be as per physician choice according to the most appropriate therapeutic opportunities available for each patients based on the type and stage of disease and the patients performance statusCurrently the NAC regimens commonly used at CRO-Aviano for NAC are Epirubicine 90 mgmq Ciclophosphamide 600 mgmq d1 q21 or q14 ECdose dense followed by weekly Paclitaxel 80 mgmq for a total of 12 administrations Occasionally due to patients and tumor features only weekly Paclitaxel is used and usually in this case up to 24 administrations may be given Only in the case of HER2 positive BC trastuzumab 2 mgkg is added to weekly Paclitaxel Given the low response rate of hormone-based neoadjuvant therapy only in rare cases eg patients not amenable of surgery due to comorbidities this approach is used
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