MedTrace Logo

A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)

NCT04317599 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 274

Last updated 2026-01-02

Study results available
· View outcomes & findings →

Summary

The presence of a BRAFV600E mutation is considered a marker of poor prognosis in patients with mCRC, and findings from clinical trials have largely remained inconclusive regarding the efficacy of first line treatments for BRAF-mutant mCRC patients. In the absence of targeted/specific treatment for BRAF-mutant mCRC, treatment practices can vary based on local practices and guidelines. There is, therefore, an unmet need to document the current practices for first-line treatment of BRAF-mutant mCRC, and their effectiveness and safety in a real-world setting.

This real-world, multicenter non-interventional study (NIS) will describe the treatment patterns, effectiveness and safety of current treatment regimens in BRAFV600E mutant mCRC patients in Europe, with the aim to put the clinical study findings of the ongoing Phase 2, single-arm, open label trial (ANCHOR) into context of the current treatment landscape excluding investigational therapies. Additionally, the NIS output may be used to support future health technology assessment submissions and publications.

Conditions

Interventions

OTHER

Non interventional

All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between 01 January, 2016 and 31 December, 2018 (both days inclusive) with drugs registered for mCRC in respective country

Sponsors & Collaborators

  • Clinact

    collaborator OTHER

  • Pierre Fabre Medicament

    lead INDUSTRY

Principal Investigators

  • Bernard Asselain, MD, PhD

  • Dirk Arnold, MD, PhD

  • Erika Martinelli, MD, PhD

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-12
Primary Completion
2021-03-04
Completion
2021-05-12
FDA Drug
Yes

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

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 NCT04317599 on ClinicalTrials.gov