Clinical trial NCT01446185: Treatment Decision Impact of OncotypeDX™ in HR+, N- Breast Cancer Patients
Official title: Treatment Decision Impact of OncotypeDX™ in HR+, N- Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Genomic Health®, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Registrat-Mapi
First posted: 2011-10-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


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.

Primary outcomes:
measure: impact of the Oncotype DX Recurrence Score on the treatment recommendation made
timeFrame: Day 15
Secondary outcomes:
measure: Level of confidence of the physicians relating to their treatment recommendation before and after Oncotype DX RS results
timeFrame: Day 15
measure: Physicians' perceptions regarding the utility of the Oncotype DX.
timeFrame: Day 15
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHRU Besançon
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Montpellier
country: France
facility: Centre Val d'Aurelle
city: Mougins
country: France
facility: Centre Azuréen de Cancérologie
city: Nancy
country: France
facility: Centre d'Oncologie Médicale de Gentilly
city: Paris
country: France
facility: Hôpital TENON
Study officials:
affiliation: Hôpital TENON
name: Joseph GLIGOROV
role: PRINCIPAL_INVESTIGATOR
References: