Ignite Creation Date:
2024-05-05 @ 11:55 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01446185
Status:
COMPLETED
Last Update Posted:
2013-04-18
First Post:
2010-09-01
Brief Title:
Treatment Decision Impact of OncotypeDX in HR N- Breast Cancer Patients
Sponsor:
Genomic Health Inc
Organization:
Genomic Health Inc
Study Overview
Official Title:
Treatment Decision Impact of OncotypeDX in HR N- Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2013-04
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:
SWITCH
Brief Summary:
Primary objective
Determine the impact of the Oncotype DX Recurrence Score RS on the treatment recommendation made administration of chemotherapy or not in addition to hormonotherapy in a HR N- or pN1mi Her2- breast cancer adjuvant population
The impact of Oncotype DX on treatment recommendations can be either a decrease in treatment intensity defined as a change in treatment recommendation from chemotherapy plus hormonal therapy to hormonal therapy alone or an increase in treatment intensity defined as a movement from hormonal therapy alone to the addition of chemotherapy to hormonal therapy
Patients with HR N- breast cancer currently represent around 70 of newly diagnosed breast cancers These are usually good prognosis tumors However on the basis of classical clinical and pathological prognostic parameters and markers the international consensus guidelines recommend treatment with hormone- and chemotherapy in 85-95 of the cases Considering the natural disease history such as documented by the EBCTCG meta-analysis more than 50 of these patients are overtreated which leads to unnecessary side effects and costs to the health system and to the society
Oncotype DX appears to be well adapted to therapeutic de-escalation as it targets HR N- patients and is performed on fixed paraffin embedded tissue FPET It is therefore best adapted to daily clinical practice as it does not necessitate any specific surgical procedure or tissue freezing
The prognostic and predictive value of Oncotype DX in ER N- patients has been validated on three large adjuvant randomized trials NASBP B-14 NSABP B-20 and the ATAC study The test has been commercially available in the USA since 2004 and is being used for more than 50 of the HR N- patients in this country
While Oncotype DX has been validated in the USA it needs to be independently evaluated in France in the context of the local treatment guidelines and habits to provide data that are meaningful to the French health system and to the French medical community
Determine the impact of the Oncotype DX Recurrence Score RS on the treatment recommendation made administration of chemotherapy or not in addition to hormonotherapy in a HR N- or pN1mi Her2- breast cancer adjuvant population
The impact of Oncotype DX on treatment recommendations can be either a decrease in treatment intensity defined as a change in treatment recommendation from chemotherapy plus hormonal therapy to hormonal therapy alone or an increase in treatment intensity defined as a movement from hormonal therapy alone to the addition of chemotherapy to hormonal therapy
Patients with HR N- breast cancer currently represent around 70 of newly diagnosed breast cancers These are usually good prognosis tumors However on the basis of classical clinical and pathological prognostic parameters and markers the international consensus guidelines recommend treatment with hormone- and chemotherapy in 85-95 of the cases Considering the natural disease history such as documented by the EBCTCG meta-analysis more than 50 of these patients are overtreated which leads to unnecessary side effects and costs to the health system and to the society
Oncotype DX appears to be well adapted to therapeutic de-escalation as it targets HR N- patients and is performed on fixed paraffin embedded tissue FPET It is therefore best adapted to daily clinical practice as it does not necessitate any specific surgical procedure or tissue freezing
The prognostic and predictive value of Oncotype DX in ER N- patients has been validated on three large adjuvant randomized trials NASBP B-14 NSABP B-20 and the ATAC study The test has been commercially available in the USA since 2004 and is being used for more than 50 of the HR N- patients in this country
While Oncotype DX has been validated in the USA it needs to be independently evaluated in France in the context of the local treatment guidelines and habits to provide data that are meaningful to the French health system and to the French medical community
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2010-A00577-32 | OTHER | AFSSAPS identification number | None |