Treatment Decision Impact of OncotypeDX™ in HR+, N- Breast Cancer Patients (SWITCH)
|ClinicalTrials.gov Identifier: NCT01446185|
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : April 18, 2013
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 pN1(mi), 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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: Oncotype DX breast cancer test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment Decision Impact of OncotypeDX™ in HR+, N- Breast Cancer Patients|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||May 2012|
|a HR+, N- or pN1(mi), Her2- breast cancer adjuvant population||
Device: Oncotype DX breast cancer test
The Oncotype DX breast cancer test measures the expression of 21 genes of an individual tumor to generate an Recurrence Score result that quantifies the magnitude of chemotherapy benefit and the likelihood of recurrence for early-stage breast cancer patients.
Other Name: Oncotype DX™
- impact of the Oncotype DX Recurrence Score on the treatment recommendation made [ Time Frame: Day 15 ]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.
- Level of confidence of the physicians relating to their treatment recommendation before and after Oncotype DX RS results [ Time Frame: Day 15 ]The change in physicians' level of confidence in the treatment recommendation will be measured by the change from baseline to follow-up responses.
- Physicians' perceptions regarding the utility of the Oncotype DX. [ Time Frame: Day 15 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446185
|Besançon, France, 25030|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Centre Azuréen de Cancérologie|
|Mougins, France, 6250|
|Centre d'Oncologie Médicale de Gentilly|
|Nancy, France, 54000|
|Paris, France, 75020|
|Principal Investigator:||Joseph GLIGOROV||Hôpital TENON|