Ignite Creation Date:
2024-05-06 @ 7:54 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02624973
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2021-08-27
First Post:
2015-11-30
Brief Title:
PErsonalized TREatment of High-risk MAmmary Cancer - the PETREMAC Trial
Sponsor:
Haukeland University Hospital
Organization:
Haukeland University Hospital
Study Overview
Official Title:
PErsonalized TREatment of High-risk MAmmary Cancer - the PETREMAC Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2021-08
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:
PETREMAC
Brief Summary:
Breast cancer is an optimal model disease for studying personalized medicine Breast cancer was the first malignancy for which a predictive factor forecasting response to therapy was identified nearly 50 years ago the expression of the estrogen receptor ER Furthermore breast cancer is by far the malignancy in which prognostic and predictive factors have been most extensively studied Primary medical treatment pre-surgical medical therapy offers a unique setting to explore predictive factors due to the fact that primary breast cancers are easily accessible to repeated tissue sampling and evaluation of therapy response both clinically and radiologically For many years the investigators have studied predictive factors in primary medical treatment of breast cancer In the present project the investigators will implement a new trial concept where the current knowledge from previous trials with respect to predictive markers hormone receptors HER2 TP53 CHEK2 and RB1 will be combined with massive parallel sequencing MPS Thereby the investigators aim to design the next-generation primary medical treatment where 1 therapy regimens are individualized based on a limited number of known predictive factors and 2 MPS is used to explore additional predictive factors and their co-regulators in order to fully identify the mechanisms of drug sensitivity resistance across individual tumours and pave the way for further personalized breast cancer therapy in the future As for the new era of genomic medicine the current trial concept will allow individual tumours to be characterized by their unique gene mutation epigenetic modification profile upfront to allocate patients to their optimal personalized medicine as compared to classical drug testing through phase IIIII trials
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None