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

NCT01446185 | Completed

• 1 other identifier: 2010-A00577-32
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

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

Keywords

HR+, N- or pN1(mi), Her2- breast cancer adjuvant population; Early Breast cancer; Gene Expression; Node-Negative; treatment options; Hormone receptor positive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Level of confidence of the physicians relating to their treatment recommendation before and after Oncotype DX RS results

  Day 15

• Physicians' perceptions regarding the utility of the Oncotype DX.

  Day 15

Study Arms (1)

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

OTHER

Device: Oncotype DX breast cancer test

Interventions

Oncotype DX breast cancer test 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.

Also known as: Oncotype DX™

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years old.
• 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.
• 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 -)
• 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.
• Patients must have given a written informed consent.

You may not qualify if:

• T3 or T4, HR-, N+ (except pN1 (mi) (sn), Her2+ (IHC 3+ or Fish+) patients.
• Metastatic patients.
• Patients who cannot give an informed consent.
• Patients who cannot receive chemotherapy.
• Mentally disabled patient who has no legal responsibility for herself.

Sponsors & Collaborators

• Genomic Health®, Inc.: lead
• Registrat-Mapi: collaborator

Study Sites (6)

CHRU Besançon

Besançon, 25030, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Azuréen de Cancérologie

Mougins, 6250, France

Location

Centre d'Oncologie Médicale de Gentilly

Nancy, 54000, France

Location

Hôpital TENON

Paris, 75020, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Joseph GLIGOROV

  Hôpital TENON

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2010
• First Posted: October 5, 2011
• Study Start: January 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: May 1, 2012
• Last Updated: April 18, 2013

Record last verified: 2013-04

Locations

FR (6)