Trial Outcomes & Findings for Re-Evaluation of Tumor Samples From Women With Breast Cancer With the in Vitro Diagnostic Kit "MammaTyperTM" (NCT NCT02244580)

Results Overview

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))

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1010 participants

Primary outcome timeframe

5 year from the date of patient randomisation

Results posted on

2016-11-07

Participant Flow

The clinical data and breast tumour tissue samples were collected within the FinHer trial (identifier ISRCTN76560285), where 1010 women with axillary node-positive or high-risk axillary node-negative breast cancer were randomly assigned between October 2000 and September 2003.

Participant milestones

Participant milestones
Measure	MammaTyper™ MammaTyper™ kit will be used to assess tumor material of patients enrolled into the FinHer trial. 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.
Overall Study STARTED	1010
Overall Study COMPLETED	769
Overall Study NOT COMPLETED	241

Reasons for withdrawal

Reasons for withdrawal
Measure	MammaTyper™ MammaTyper™ kit will be used to assess tumor material of patients enrolled into the FinHer trial. 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.
Overall Study No cancer tissues available	241

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FinHer Patients n=1010 Participants Of all patients, FFPE tumour block was processed with the RNXtract RNA extraction kit (BioNTech Diagnostics GmbH, Mainz) using a magnetic particle-based assay (Supplemental file 1A). RT-qPCR was done with the MammaTyper kit (BioNTech Diagnostics GmbH, Mainz) for ESR1, PGR, ERBB2 and MKI67.
Age, Continuous	50.9 years n=5 Participants
Sex: Female, Male Female	1010 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Finland	1010 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 year from the date of patient randomisation

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))

Outcome measures

Outcome measures
Measure	Luminal A n=769 Participants Patients subtyped as Luminal A with DDFS determined 5 years after randomisation	Combined Subtype n=769 Participants Patients subtyped as Luminal B, HER2 positive, triple negative with DDFS determined 5 years after randomisation
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 percentage of analyzed participants	82 percentage of analyzed participants

SECONDARY outcome

Timeframe: 5 years

High Ki-67 is prognostic for worse outcome for DDFS and OS (measured by hazard ratio)

Outcome measures

Outcome measures
Measure	Luminal A n=769 Participants Patients subtyped as Luminal A with DDFS determined 5 years after randomisation	Combined Subtype Patients subtyped as Luminal B, HER2 positive, triple negative with DDFS determined 5 years after randomisation
Number of Patients With High Ki-67 and Prognosis on Outcome for DDFS and OS (Measured by Hazard Ratio)	0.42 Hazard ratio Interval 0.25 to 0.71	—

SECONDARY outcome

Timeframe: 5 years

Superiority of outcome prediction for MammaTyper™ Ki-67 over local Ki-67 eyeballed assessment for Luminal tumors with regard to OS and DDFS

Outcome measures

Outcome measures
Measure	Luminal A n=769 Participants Patients subtyped as Luminal A with DDFS determined 5 years after randomisation	Combined Subtype n=769 Participants Patients subtyped as Luminal B, HER2 positive, triple negative with DDFS determined 5 years after randomisation
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 DDFS (MKI67 mRNA positive - negative)	0.42 Hazard ratio Interval 0.25 to 0.71	0.45 Hazard ratio Interval 0.23 to 0.88
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 DDFS (Ki-67 protein positive - negative)	0.56 Hazard ratio Interval 0.37 to 0.84	0.43 Hazard ratio Interval 0.24 to 0.77

Adverse Events

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Oed

Biontech Diagnostics GmbH

Phone: +49 6131/ 6358030

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place