A Trial Using ctDNA Blood Tests to Detect Cancer Cells After Standard Treatment to Trigger Additional Treatment in Early Stage Triple Negative Breast Cancer Patients

NCT03145961 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2022-02-24

No results posted yet for this study

Summary

c-TRAK TN is a multi-centre phase II study, consisting of a circulating tumour DNA (ctDNA) surveillance component and a therapeutic component. c-TRAK TN aims to assess whether ctDNA surveillance can be used to detect residual disease following patients standard primary treatment for triple negative breast cancer, and will assess the safety and activity of the investigational medicinal product pembrolizumab.

Conditions

Interventions

DRUG

Pembrolizumab

200mg intravenous infusion

Sponsors & Collaborators

  • National Institute for Health Research Biomedical Research Centre at the Royal Marsden / Institute of Cancer Research UK

    collaborator UNKNOWN
  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY
  • Institute of Cancer Research, United Kingdom

    lead OTHER

Principal Investigators

  • Nick Turner · Royal Marsden NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-21
Primary Completion
2021-09-30
Completion
2024-03-31

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT03145961 on ClinicalTrials.gov