Central Pathology Review

Central Pathology Review of FFPE tumor blocks within the POSITIVE study

The primary goal of the POSITIVE trial is to determine if a two-year interruption of endocrine therapy results in a significantly higher breast cancer event rate in comparison to a historically estimated control rate if no interruption occurred. Samples have been collected from 90 % of the patients enrolled in the POSITIVE clinical trial and funding is required for processing and analysis.

Lay Abstract

Pregnancy is a major concern for premenopausal breast cancer survivors. Conception after breast cancer in women with hormone receptor positive (HR+) disease is affected by the standard 5-10 years of anti-hormonal therapy during which pregnancy is contraindicated. 
The POSITIVE study evaluates whether it is safe, in terms of risk of breast cancer recurrence, to temporarily interrupt adjuvant endocrine therapy to attempt pregnancy. It is also an exceptional opportunity to investigate the biology of breast cancer in young patients, a subset that is well-known to be biologically distinct, yet poorly studied particularly at the molecular and genomic level.  
The Central Pathology Review is a crucial component of multicenter tumor trials. Therefore, within the POSITIVE Study, it is integral to centrally collect patient tumor tissue and review tumor biological characteristics (such as ER, PR, Ki67 and HER2) alone and in combination with clinical-pathological parameters (grade of tumor, size of tumor, nodal status and patient age). The aim is to evaluate whether treatment interruption for some women with high-risk tumors may be detrimental and whether pregnancy might modify the risk of cancer relapse. 
The data obtained will therefore permit individualized assessment of patient outcomes according to the biologic characteristics of the tumor as well as a better understanding of the overall results of the POSITIVE study. In addition, the results of the Central Pathology Review will enable future molecular subtyping in order to better tailor treatment in this population and help future patients fulfill their motherhood wish, without risking breast cancer relapse.