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

NCT ID: NCT01446185

Last Updated: 2013-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-05-31

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 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

a HR+, N- or pN1(mi), Her2- breast cancer adjuvant population

Group Type: OTHER

Oncotype DX breast cancer test

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Oncotype DX™

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Registrat-Mapi

OTHER

Sponsor Role: collaborator

Genomic Health®, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph GLIGOROV

Role: PRINCIPAL_INVESTIGATOR

Hôpital TENON

Locations

CHRU Besançon

Besançon, , France

Centre Jean Perrin

Clermont-Ferrand, , France

Centre Val d'Aurelle

Montpellier, , France

Centre Azuréen de Cancérologie

Mougins, , France

Centre d'Oncologie Médicale de Gentilly

Nancy, , France

Hôpital TENON

Paris, , France

Countries

France

Other Identifiers

2010-A00577-32

Identifier Type: OTHER

Identifier Source: secondary_id

2010-A00577-32

Identifier Type: -

Identifier Source: org_study_id