Treatment Decision Impact of OncotypeDX™ in HR+, N- Breast Cancer Patients (SWITCH)

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 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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Oncotype DX breast cancer test

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • CHRU Besançon
  • Clermont-Ferrand, France, 63011
    • Centre Jean Perrin
  • Montpellier, France, 34298
    • Centre Val d'Aurelle
  • Mougins, France, 6250
    • Centre Azuréen de Cancérologie
  • Nancy, France, 54000
    • Centre d'Oncologie Médicale de Gentilly
  • Paris, France, 75020
    • Hôpital Tenon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Patients > 18 years old.
2. Pre- or post- menopausal women with breast adenocarcinoma, confirmed by a pathologist and who underwent surgery, with a maximum of 4 weeks between surgery and the 2nd therapeutic decision with Oncotype DX.
3. HR positive (at least ER+) breast cancer patients (defined by a threshold of 10% of the cells IHC + without N- or pN1(mi), Her2 - (IHC0, 1, 2+ or FISH -)
4. Patients must be eligible to receive adjuvant chemotherapy as defined by a good Karnofsky index, no hematological, cardiological or hepatic contraindications nor any impeding comorbidity.
5. Patients must have given a written informed consent.

Exclusion Criteria:

1. T3 or T4, HR-, N+ (except pN1 (mi) (sn), Her2+ (IHC 3+ or Fish+) patients.
2. Metastatic patients.
3. Patients who cannot give an informed consent.
4. Patients who cannot receive chemotherapy.
5. Patient who participated in another clinical trial and is still in the exclusion period of any other trial.
6. Mentally disabled patient who has no legal responsibility for herself.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Oncotype DX™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
impact of the Oncotype DX Recurrence Score on the treatment recommendation made	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.	Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of confidence of the physicians relating to their treatment recommendation before and after Oncotype DX RS results	The change in physicians' level of confidence in the treatment recommendation will be measured by the change from baseline to follow-up responses.	Day 15
Physicians' perceptions regarding the utility of the Oncotype DX.		Day 15

Collaborators and Investigators

• Sponsor: Genomic Health®, Inc.
• Collaborators: Registrat-Mapi
• Investigators: Principal Investigator: Joseph GLIGOROV, Hôpital Tenon

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: September 1, 2010
• First Submitted That Met QC Criteria: October 3, 2011
• First Posted (Estimate): October 5, 2011

Study Record Updates

• Last Update Posted (Estimate): April 18, 2013
• Last Update Submitted That Met QC Criteria: April 17, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Early Breast cancer; Gene Expression; Hormone receptor positive; treatment options; HR+, N- or pN1(mi), Her2- breast cancer adjuvant population; Node-Negative
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2010-A00577-32 (Other Identifier: AFSSAPS identification number)