NCT02244580

Re-Evaluation of Tumor Samples From Women With Breast Cancer With the in Vitro Diagnostic Kit "MammaTyperTM"

Evaluation of the MammaTyperTM Kit, Ref 90020/90021 Performed on Clinical Material Obtained From Patients With Breast Cancer: Re-Examination of Tumor Material and Re-Evaluation of Patient Data of the FinHer-Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,010 (actual)
• Sponsor: BioNTech Diagnostics GmbH · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective examination of tumor material of breast cancer patients randomized into the FinHer-trial (= (= Comparison of vinorelbine and docetaxel and trastuzumab as adjuvant treatments of breast cancer patients wirh a high risk of cancer recurrence). The formalin-fixed, paraffin-embedded tissue samples will be analysed for Estrogen receptor 1 (ESR1), progesterone receptor (PgR), Human epidermal growth factor receptor 2 (HER2) and Antigen Ki-67 (Ki-67) with the molecular in vitro diagnostic kit MammaTyper™. According to the new subtyping the 5 year Distant disease free survival (DDFS) and Overall survival (OS) will be re-evaluated.

Detailed description

Despite the fact that reliable measures for the markers ESR1, PgR, HER2, Ki-67 are necessary with the currently used methods up to 20% of determinations are inaccurate and especially Ki67- measures are not very reproducible. Therefore new evaluation systems or new methods are necessary to improve diagnostic. At least 4 subtypes can be distinguished to date depending on the expression of ESR, PgR, Her2 and Ki-67: * Luminal A-type * Luminal B-type * Her2-type * Triple-negative-type MammaTyper™ uses a new approach. Instead of detection of the marker proteins, the messenger ribonucleic adic (mRNA) of marker proteins is quantitated. This prospectively planned diagnostic study will investigate the potential of subgrouping of patients at baseline according to results of MammaTyper™ methodology for predicting survival. Patients will be subgrouped according to the new marker determination and the DDFS and OS will be evaluated and compared to the DDFS and OS of subgrouping with former marker determination.

Conditions

• Invasive Breast Cancer

Interventions

Type	Name	Description
DEVICE	MammaTyper™	MammaTyper™ kit is a molecular in vitro diagnostic test for the quantitative detection of the ribonuclease acid (RNA) expression status of the genes for estrogen receptor (ESR1), progesterone receptor (PGR), human epidermal growth factor receptor 2 (HER2) and proliferation antigen KI 67.

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2014-09-19
• Last updated: 2016-11-07
• Results posted: 2016-11-07