Re-Examination of Tumor Material and Re-Evaluation of Patient Data From Patients Treated With Neo-adjuvant Therapy
Trial status:Study Complete
Trial ID:
MammaTyper_1.neo-adjuvant st.
NCT ID:
EudraCT ID:
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 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 MammaTyperâ„¢. 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.
Medical Condition
Trial Drug
Phase
N/A
Type
Observational
Estimated Enrolment
101
Estimated Trial Date
Jun 2014 - Sep 2014
Trial Participant Requirements
Age
18 - 70 Years
Sex
Female
Healthy Volunteers
No
Trial Locations
No locations found.