Pharmacogenetic study of Fc?RIIIa and HER2 genes in relation to treatment of breast cancer - HER2 PG study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002532-24-GB

Enrollment

750

Registered

2007-04-17

Start date

2007-05-10

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer. MedDRA version: 8.1 Level: LLT Classification code 10006203 Term: Breast cancer stage unspecified

Interventions

Trade Name: Herceptin Product Name: Trastuzumab Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Trastuzumab CAS Number: 180288-69-1 Other descriptive name: TRASTUZUMAB Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) Aged 18 years or over. b) Histological confirmation of primary breast cancer with HER2 testing. c) Written voluntary informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: a) Under the age of 18 years. b) Unable to give informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objectives: i) To determine the influence and frequency of polymorphisms in the Fc?RIIIa, HER2 and other related genes on response to trastuzumab with respect to time-to-progression (TTP) and outcome (in patients with advanced/ metastatic breast cancer). ii) To determine the frequency of polymorphisms in the HER2 gene and their association with HER2 expression in tumour samples in both the adjuvant and metastatic setting.;Secondary Objective: i) To determine the frequency and influence of polymorphisms in the Fc?RIIIa, HER2 and other associated genes in breast cancer specimens. ii) To evaluate pharmacokinetic and pharmacodynamic parameters potentially influencing patients' outcome (investigating levels of trastuzumab and associated biomarkers).;Primary end point(s): The primary endpoint of this study is the frequency of specific genetic variations between individuals: in the HER2 gene with respect to HER2 receptor expression and the Fc?RIIIa and related genes with respect to response to trastuzumab in the treatment of HER2-overexpressing breast cancer.	—

Measure

Time frame

Main Objective: Primary objectives: i) To determine the influence and frequency of polymorphisms in the Fc?RIIIa, HER2 and other related genes on response to trastuzumab with respect to time-to-progression (TTP) and outcome (in patients with advanced/ metastatic breast cancer). ii) To determine the frequency of polymorphisms in the HER2 gene and their association with HER2 expression in tumour samples in both the adjuvant and metastatic setting.;Secondary Objective: i) To determine the frequency and influence of polymorphisms in the Fc?RIIIa, HER2 and other associated genes in breast cancer specimens. ii) To evaluate pharmacokinetic and pharmacodynamic parameters potentially influencing patients' outcome (investigating levels of trastuzumab and associated biomarkers).;Primary end point(s): The primary endpoint of this study is the frequency of specific genetic variations between individuals: in the HER2 gene with respect to HER2 receptor expression and the Fc?RIIIa and related genes with respect to response to trastuzumab in the treatment of HER2-overexpressing breast cancer.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026