ER-positive Her2-negative Early Breast Cancer Clinical Trial
Official title:
Prospective Multicenter Randomized Study Assessing Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in Patients With ER-positive, Her2-negative Early Breast Cancer With Uncertainty on the Indication of Chemotherapy Using Standard Assessments.
The need/benefit of adjuvant chemotherapy could be negligible for a certain category of
patient with newly diagnosed unilateral non metastatic breast cancer. Physicians are
sometimes divided between the administration of adjuvant treatment and no administration when
the risk of distant relapse at 10 years is around 10% with uncertainty and a theoretical
benefit of chemotherapy is less than 5% at 10 years according to guidelines in use in the
center.
Several genomic tests have been developed this last decade. These tests use a sample of
breast cancer tissue to analyze the activity of a group of genes. Knowing whether certain
genes are present or absent, overly active or not active enough, can help physicians predict
the risk of recurrence.
In addition to standard pathological characteristics, a genomic test could be helpful in
making treatment decisions, such as whether or not chemotherapy should be part of the
treatment plan. First generation prognostic tests are currently widely used worldwide to
guide decision making regarding adjuvant chemotherapy (OncotypeDX™ Mammaprint®). Prognostic
tests have reached a level of evidence 1A, with the results of the prospective randomized
trial "Mindact". In the "Mindact" trial, among women with early-stage breast cancer who were
at high clinical risk and low genomic risk for recurrence, the receipt of no chemotherapy on
the basis of the 70-gene signature led to a 5-year rate of survival without distant
metastasis that was 1.5 percentage points lower than the rate with chemotherapy. Given these
findings, approximately 46% of women with breast cancer who are at high clinical risk might
not require chemotherapy. The health-economic value of such signatures in the general
population of patients with localized breast cancer appears very low at current costs.
Meanwhile, next generation prognostic signatures have been developed that have integrated
clinical parameters and suggest high added value beyond all standard and traditional
characteristics including tumor burden, grade, Estrogen Receptor (ER) and Progesterone
Receptor (PR), Her2, age and also standard assessment of proliferation.
In this study, the clinical utility of genomic tests (Endopredict®, Prosigna®, OncotypeDX®,
Mammaprint® assay) defined as impact on chemotherapy decision in the adjuvant setting in
patients with ER-positive, Her2-negative early breast cancer with uncertainty on the
indication of chemotherapy using standard assessments will be compared.
n/a