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Re-Examination of Tumor Material and Re-Evaluation of Patient Data From Patients Treated With Neo-adjuvant Therapy

NCT02449993 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 101

Last updated 2017-01-18

No results posted yet for this study

Summary

This is a prospective examination of ribonucleic acid (RNA) extracted from tumor material of breast cancer patients treated with a neo-adjuvant therapy. The RNA will be analysed for expression of estrogen receptor (ER 1), progesterone receptor (PgR), HER2 and Ki-67 with MammaTyper™.

According to the determined values for the individual parameters at least 4 subtypes can be distinguished to date

* Luminal A-type
* Luminal B-type
* HER2-type
* Triple-negative-type As non-clinical endpoint, the agreement of new subtyping with Immunohistochemical methods will be evaluated.

As clinical objective, the 5 year Distant metastasis free survival (DMFS) and Overall survival (OS) will be reevaluated according to the new subtyping.

Conditions

Interventions

DEVICE

MammaTyper™

MammaTyper™ is an in vitro molecular diagnostic test for the quantitative detection of the biomarkers estrogen receptor (ESR1), progesterone receptor ( PgR), Human epidermal growth factor receptor 2 (HER2) and proliferation antigen Ki-67 on the basis of the values of the messenger ribonucleic acid (mRNA).

Sponsors & Collaborators

  • BioNTech Diagnostics GmbH

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-09-30
Completion
2014-10-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02449993 on ClinicalTrials.gov