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CharactHer. ICORG 12-09, V3

NCT01722890 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2025-07-08

No results posted yet for this study

Summary

Primary Objective:

The primary aim of the study is:

1.To identify and validate a panel of molecular and cytogenetic biomarkers able to predict Durable Complete Response (DCR) after chemotherapy and trastuzumab in patients with HER2-positive locally advanced or metastatic breast cancer.

Secondary Objective:

The secondary aims of the study are:

1. To perform a comprehensive exploration of the molecular and cytogenetic characteristics of DCR patients to identify any possible correlation between the tumour's biological and cytogenetic characteristics and the degree of clinical response to trastuzumab;
2. To produce data in preparation for further translational studies on HER2-positive breast cancer.

Conditions

Sponsors & Collaborators

  • Cancer Trials Ireland

    lead NETWORK

Principal Investigators

  • Giuseppe Gullo, Medicine and Surgery · St Vincent's University Hospital

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2021-01-27
Completion
2021-01-27

Countries

  • Ireland
  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01722890 on ClinicalTrials.gov