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

This study has been completed.
Sponsor:
Collaborator:
Registrat-Mapi
Information provided by (Responsible Party):
Genomic Health®, Inc.
ClinicalTrials.gov Identifier:
NCT01446185
First received: September 1, 2010
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Device: Oncotype DX breast cancer test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Treatment Decision Impact of OncotypeDX™ in HR+, N- Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Genomic Health®, Inc.:

Primary Outcome Measures:
  • impact of the Oncotype DX Recurrence Score on the treatment recommendation made [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Level of confidence of the physicians relating to their treatment recommendation before and after Oncotype DX RS results [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: January 2011
Study Completion Date: May 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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™

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01446185

Locations
France
CHRU Besançon
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
Hôpital TENON
Paris, France, 75020
Sponsors and Collaborators
Genomic Health®, Inc.
Registrat-Mapi
Investigators
Principal Investigator: Joseph GLIGOROV Hôpital TENON
  More Information

No publications provided

Responsible Party: Genomic Health®, Inc.
ClinicalTrials.gov Identifier: NCT01446185     History of Changes
Other Study ID Numbers: 2010-A00577-32, 2010-A00577-32
Study First Received: September 1, 2010
Last Updated: April 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Genomic Health®, Inc.:
HR+, N- or pN1(mi), Her2- breast cancer adjuvant population
Early Breast cancer
Gene Expression
Node-Negative
treatment options
Hormone receptor positive

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014