Ignite Creation Date:
2024-05-06 @ 6:26 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05666258
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2022-12-16
Brief Title:
Gene Expression Profiling to Help Define the Need for Neo-Adjuvant Chemotherapy in HR HER- Breast Cancer Patients
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Universitair Ziekenhuis Brussel
Study Overview
Official Title:
Gene Expression Profiling to Help Define the Need for Neo-Adjuvant Chemotherapy in HR HER- Breast Cancer Patients
Status:
RECRUITING
Status Verified Date:
2023-10
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:
NACAGEP
Brief Summary:
The goal of the experiment is surgical de-escalation Patients with newly diagnosed cT1-3 cN1 cM0 and HR HER2- breast cancer and low clinical risk usually first receive breast cancer surgery after which chemotherapy can be added based on the final anatomopathological results or additional Gene Expression Profiling GEP testing
Chemotherapy helps reduce the cancer recurrence or metastasis risk Adjuvant chemotherapy AC can be given for large tumours aggressive tumours with high grade tumour cells or if axillary lymph node invasion is discovered during surgery If the investigators were able to identify patients requiring chemotherapy prior to surgery they could treat them with Neo-Adjuvant Chemotherapy NAC instead By using MammaPrint GEP the investigators would be able to stratify patients into either a low- or high-risk category Since the high-risk group is known to benefit from chemotherapy to improve overall survival they would be treated with NAC which could also potentially lead to surgical de-escalation Breast conserving procedures such as a lumpectomy instead of a mastectomy could allow more aesthetically pleasing results and increase patient quality of life Using NAC for patients with axillary lymph node invasion could lead to nodal complete pathological response cN1 - ypN0 allowing patients that are willing to enter the TADANAC trial a lymph node sparing procedure instead of a full axillary lymph node dissection
Chemotherapy helps reduce the cancer recurrence or metastasis risk Adjuvant chemotherapy AC can be given for large tumours aggressive tumours with high grade tumour cells or if axillary lymph node invasion is discovered during surgery If the investigators were able to identify patients requiring chemotherapy prior to surgery they could treat them with Neo-Adjuvant Chemotherapy NAC instead By using MammaPrint GEP the investigators would be able to stratify patients into either a low- or high-risk category Since the high-risk group is known to benefit from chemotherapy to improve overall survival they would be treated with NAC which could also potentially lead to surgical de-escalation Breast conserving procedures such as a lumpectomy instead of a mastectomy could allow more aesthetically pleasing results and increase patient quality of life Using NAC for patients with axillary lymph node invasion could lead to nodal complete pathological response cN1 - ypN0 allowing patients that are willing to enter the TADANAC trial a lymph node sparing procedure instead of a full axillary lymph node dissection
Detailed Description:
None
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