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

NCT02244580 | Completed Results

• 1 other identifier: MammaTyper-FinHer
• Study Type: interventional
• Target: 1,010
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Invasive Breast Cancer

Keywords

Subtyping of Invasive breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 randomisation

Secondary Outcomes (2)

• Number of Patients With High Ki-67 and Prognosis on Outcome for DDFS and OS (Measured by Hazard Ratio)

  5 years

• 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

  5 years

Study Arms (1)

MammaTyper™

EXPERIMENTAL

MammaTyper™ kit will be used tio assess tumor material of patients enrolled into the FinHer trial.

Device: MammaTyper™

Interventions

MammaTyper™ DEVICE

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.

MammaTyper™

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• BioNTech Diagnostics GmbH: lead

Results Point of Contact

• Title: Dr. Michael Oed
• Organization: Biontech Diagnostics GmbH

michael.oed@theracode.de

+49 6131/ 6358030

Study Officials

• Michael Oed, Dr.

  BioNTech Diagnostics GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 19, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 7, 2016
• Results First Posted: November 7, 2016

Record last verified: 2016-09