Invasive Breast Cancer Clinical Trial
Official title:
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
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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