Status:
COMPLETED
Re-Evaluation of Tumor Samples From Women With Breast Cancer With the in Vitro Diagnostic Kit "MammaTyperTM"
Lead Sponsor:
BioNTech Diagnostics GmbH
Conditions:
Invasive Breast Cancer
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
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 b...
Detailed Description
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 ar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
1010 Patients enrolled
Trial Details
Trial ID
NCT02244580
Start Date
August 1 2014
End Date
August 1 2014
Last Update
November 7 2016
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