N/A
N=1,010
Re-Evaluation of Tumor Samples From Women With Breast Cancer With the in Vitro Diagnostic Kit "MammaTyperTM"
Invasive Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02244580 ↗Enrolled (actual)
1,010
Serious AEs
—
Results posted
Nov 2016
Primary outcome: Primary: 5 Year Distant Disease Free Survival (DDFS) Assessed as Rate of Patients Without Distant Metastases in Subgroup Luminal A vs. Combined Subgroup (Luminal B, HER2 Positive, Triple Negative), Based on Subtyping With MammaTyper™ — 92; 82 percentage of analyzed participants — p=0.0018
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MammaTyper™ (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- BioNTech Diagnostics GmbH
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 5 Year Distant Disease Free Survival (DDFS) Assessed as Rate of Patients Without Distant Metastases in Subgroup Luminal A vs. Combined Subgroup (Luminal B, HER2 Positive, Triple Negative), Based on Subtyping With MammaTyper™ |
92; 82 | 0.0018 sig |
| SECONDARY Number of Patients With High Ki-67 and Prognosis on Outcome for DDFS and OS (Measured by Hazard Ratio) |
0.42 | 0.001 sig |
| SECONDARY Number of Patients With Ki-67 Determined by MammaTyper™ Compared to Local Ki-67 Eyeballed Assessment for Luminal Tumors and Correlation to Rate of Patients With Regard to OS and DDFS |
0.42; 0.45; 0.56; 0.43 | — |
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 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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02244580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.