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Active, Not Recruiting

NCT Number: NCT03077776

Tracking Triple-negative Breast Cancer Evolution Through Therapy

A prospective multicentre study which aims to examine the relationship between intratumour heterogeneity (ITH) and pathological response to neoadjuvant chemotherapy in patients with histological confirmation of triple-negative breast cancer (TNBC) who are eligible for neoadjuvant chemotherapy.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Triple-Negative Breast Neoplasm Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Jean Perrin, Clermont-Ferrand, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-years or older
  • Patients with histological confirmation of invasive breast cancer with known receptor status suitable for neoadjuvant chemotherapy as assessed by the local investigator
  • Estrogen receptor (ER)- and progesterone receptor (PR)-negative as defined by ≤1% of positive staining on immunohistochemistry
  • Human epidermal growth factor receptor 2 (HER2)-negative as defined by American Society of Clinical Oncology / College of American Pathologists guidelines
  • T1c-4 tumours (including inflammatory cancers), with any nodal status non candidate for conservative surgery upfront. Bilateral or multifocal cancer is permitted provided that all sites are HER2-negative and at least one site is ER- and PR-negative.
  • Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
  • Patient with social insurance coverage

Exclusion criteria

  • Confirmed metastatic disease at initial presentation
  • Any contraindication to the biopsy procedure
  • Previous or current malignancies of other origin within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin
  • Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol
  • Individuals deprived of liberty or placed under the authority of a tutor

Treatment and study plan

Biopsy

Procedure

Biopsy of primary tumour to be performed prior to initiation of neoadjuvant chemotherapy

Biopsy (optional)

Procedure

[Optional] biopsy of primary tumour to be performed after 4 weeks of neoadjuvant chemotherapy

Biopsy (metastatic)

Procedure

Biopsy of metastatic site to be performed at the time of relapse

Primary outcomes

  1. Rate of pathological complete response (pCR)

    Time frame: pCR will be defined at the time of surgery on the tumor specimen

    pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis ypN0 in the current American Joint Committee on Cancer [AJCC] staging system)

Secondary outcomes

  1. Invasive disease-free survival

    Time frame: from surgery until 5 years post-surgery

    the time from neoadjuvant treatment initiation until the date of the first occurrence of one of the following events: invasive ipsilateral breast tumour recurrence (same breast), local /regional invasive recurrence, invasive contra lateral breast cancer, appearance of metastasis, second primary invasive cancer (non-breast cancer), ipsilateral ductal carcinoma in situ, contralateral ductal carcinoma in situ, death attributable to any cause.

  2. Overall survival

    Time frame: from surgery until 5 years post-surgery

    the time from neoadjuvant treatment until death due to any cause

Sponsors and collaborators

Lead sponsor

UNICANCER

Other

Collaborators

  • National Cancer Institute, France

Registry information

Acronym: TRACERX-TNBC

Important dates

Study start
2017
Primary completion
2024
Study completion
2026
First posted
Mar 13, 2017
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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