Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363812
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-09
Brief Title:
Probability of OncotypeDx to Reallocate as Low or High Risk of Recurrence Breast Cancer Patients With Uncertain Biology
Sponsor:
Fondazione Sandro Pitigliani
Organization:
Fondazione Sandro Pitigliani
Study Overview
Official Title:
Prospective Study Evaluating the Probability of OncotypeDx to Allocate at Low or High Risk of Recurrence Early ER Positive HER2 Negative Breast Cancer Patients With Uncertain Biological Behavior Evaluated by Pathological Parameters
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
In some cases of hormone receptor positive human epidermal growth factor receptor 2 HER2 negative early breast cancer the benefit of adding adjuvant chemotherapy to hormonal treatment estimated on the basis of the classical clinico-pathological parameters is unclear In these cases the application of a genomic test could be useful in guiding the therapeutic choice
Detailed Description:
Oncotype Dx ODx is a 21-gene assay that classifies primary ER breast tumors into three categories of recurrence risk High HR Intermediate IR and Low LR
Available data show that
1 patients with ODx low score breast cancer perform well without chemotherapy
2 chemotherapy has an additive value to endocrine therapy in patients with ODx high score tumors and
3 the role of chemotherapy is unknown in patients with ODx intermediate score cancer
In this study the investigators aim to evaluate the capability of ODx to help in guiding the choice of systemic adjuvant treatment in a group of patients with ER and HER2- node negative pN0 or micrometastatic pNmi breast cancer with uncertain biological behavior for whom there is uncertainty about the indication of adjuvant chemotherapy
Available data show that
1 patients with ODx low score breast cancer perform well without chemotherapy
2 chemotherapy has an additive value to endocrine therapy in patients with ODx high score tumors and
3 the role of chemotherapy is unknown in patients with ODx intermediate score cancer
In this study the investigators aim to evaluate the capability of ODx to help in guiding the choice of systemic adjuvant treatment in a group of patients with ER and HER2- node negative pN0 or micrometastatic pNmi breast cancer with uncertain biological behavior for whom there is uncertainty about the indication of adjuvant chemotherapy
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