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Liquid Biopsy: Intercepting Mutational Trajectories of HER2 (Human Epidermal Growth Factor Receptor 2) Breast Cancer (GIM21 Trial)

NCT05735392 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-02-21

No results posted yet for this study

Summary

This is an open, interventional, non-pharmacological, prospective study. Patients will receive trastuzumab emtansine (T-DM1) at 3.6 mg/kg intravenously every 21 days, as per Summary of Product Characteristics (SmPC). This is a no-profit study.

Conditions

Interventions

OTHER

Both blood and tissues collection for patients with metastatic breast cancer HER2+ pretreated with no more than one line of anti-HER2 therapy for advanced breast cancer.

Both blood and tissues will be obtained duringT-DM1 treatment of enrolled patients at the participating Sites at the study specific timelines.

Sponsors & Collaborators

  • Consorzio Oncotech

    lead OTHER

Principal Investigators

  • Alessandra Fabi, MD · Clinical issues - Fondazione Policlinico Gemelli

  • Patrizio Giacomini · Central laboratory assesment and liquid biopsy - Oncogenomics and Epigenetics - Istituto Nazionale Tumori "Regina Elena"

  • Francesco Cognetti · Chairman - Istituto Nazionale Tumori "Regina Elena"

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-07
Primary Completion
2022-01-12
Completion
2022-01-12

Countries

  • Italy

Study Locations

More Related Trials

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 NCT05735392 on ClinicalTrials.gov