Re-Evaluation of Tumor Samples From Women With Breast Cancer With the in Vitro Diagnostic Kit "MammaTyperTM"

Invasive Breast Cancer Clinical Trial

Official title:

Evaluation of the MammaTyperTM Kit, Ref 90020/90021 Performed on Clinical Material Obtained From Patients With Breast Cancer: Re-Examination of Tumor Material and Re-Evaluation of Patient Data of the FinHer-Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02244580
• Other study ID #: MammaTyper-FinHer
• Status: Completed
• Phase: N/A
• First received: September 4, 2014
• Last updated: September 17, 2014
• Start date: August 2014
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Biontech Diagnostics GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 are not very reproducible. Therefore new evaluation systems or new methods are necessary to improve diagnostic.

At least 4 subtypes can be distinguished to date depending on the expression of ESR, PgR, Her2 and Ki-67:

• Luminal A-type

• Luminal B-type

• Her2-type

• Triple-negative-type

MammaTyper™ uses a new approach. Instead of detection of the marker proteins, the messenger ribonucleic adic (mRNA) of marker proteins is quantitated. This prospectively planned diagnostic study will investigate the potential of subgrouping of patients at baseline according to results of MammaTyper™ methodology for predicting survival.

Patients will be subgrouped according to the new marker determination and the DDFS and OS will be evaluated and compared to the DDFS and OS of subgrouping with former marker determination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1010
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Neoplasms
• Invasive Breast Cancer

Intervention

Device:
• MammaTyper™
MammaTyper™ kit is a molecular in vitro diagnostic test for the quantitative detection of the ribonuclease acid (RNA) expression status of the genes for estrogen receptor (ESR1), progesterone receptor (PGR), human epidermal growth factor receptor 2 (HER2) and proliferation antigen KI 67.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biontech Diagnostics GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
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™	Tumor material of breast cancer patients will be newly assessed by MammaTyper™ and 5 year DDFS will be calculated new according to new subgrouping (Luminal A vs. combined subgroup (Luminal B, HER2 positive, triple negative))	5 year from the date of patient registration	No
Secondary	Number of patients with high Ki-67 and prognosis on outcome for DDFS and OS (measured by hazard ratio)	High Ki-67 is prognostic for worse outcome for DDFS and OS (measured by hazard ratio)	5 years	No
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	Superiority of outcome prediction for MammaTyper™ Ki-67 over local Ki-67 eyeballed assessment for Luminal tumors with regard to OS and DDFS	5 years	No