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
Collaborator:
N/A
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
Study 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
Inclusion and Exclusion Criteria
Inclusion criteria
- Invasive breast cancer verified in a histological biopsy
- Age 65 or younger
- Estrogen receptor (ER), PgR and HER2 expression have been determined
- No distant metastases present (M0)
- The patient provides a written informed consent for study participation
- The estimated risk of breast cancer recurrence is high (25% or higher within the first 5 years from the date of the diagnosis, over \>35% within the first 10 years from the diagnosis)
Exclusion criteria
- Patients with breast cancer with "a special histological type" (mucinous, papillary, medullary, or tubular type of breast cancer) when no metastases are present in the ipsilateral axillary lymph nodes
- The WHO performance status is moderate/poor, Z \>1
- The peripheral blood leukocyte count is less than 3.0 x 109/L, the blood granulocyte count is less than 1.5 x 109/L, or the blood thrombocyte count is less than 120 x 109/L
- Any physical or mental disorder that is considered to prohibit administration of chemotherapy
- Cardiac failure; severe cardiac arrythmia requiring regular medication
Trial Locations
No locations found.