Re-Evaluation of Tumor Samples From Women With Breast Cancer With the in Vitro Diagnostic Kit "MammaTyperTM"
Trial status:Study Complete
Trial ID:
MammaTyper-FinHer
NCT ID:
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech Diagnostics GmbH
Study Complete
Trial Details
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.
Medical Condition
Trial Drug
N/A
Phase
N/A
Type
Interventional
Estimated Enrolment
1010
Estimated Trial Date
Aug 2014 - Aug 2014
Trial Participant Requirements
Age
18 - 65 Years
Sex
Female
Healthy Volunteers
No
Trial Locations
No locations found.