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

18 Years
Not Enrolling
Breast Cancer

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Trial Information

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

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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

impact of the Oncotype DX Recurrence Score on the treatment recommendation made

Outcome Description:

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.

Outcome Time Frame:

Day 15

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpital TENON


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

January 2011

Completion Date:

May 2012

Related Keywords:

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