Tracking Triple-negative Breast Cancer Evolution Through Therapy (TRACERX-TNBC)

April 15, 2024 updated by: UNICANCER
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France
        • Centre Jean Perrin
      • Dijon, France
        • Centre George François Leclerc
      • Lyon, France
        • Centre Leon Berard
      • Marseille, France
        • Institut Paoli Calmettes
      • Nantes, France
        • Institut de Cancerologie de L'Ouest
      • Rennes, France
        • Centre Eugène Marquis
      • Strasbourg, France
        • Centre Paul Strauss
      • Strasbourg, France
        • Hopitaux universitaire de strasbourg - Hopital civil
      • Vandœuvre-lès-Nancy, France
        • Institut de Cancerologie de Lorraine
      • Villejuif, France
        • Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-years or older
  2. Patients with histological confirmation of invasive breast cancer with known receptor status suitable for neoadjuvant chemotherapy as assessed by the local investigator
  3. Estrogen receptor (ER)- and progesterone receptor (PR)-negative as defined by ≤1% of positive staining on immunohistochemistry
  4. Human epidermal growth factor receptor 2 (HER2)-negative as defined by American Society of Clinical Oncology / College of American Pathologists guidelines
  5. 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.
  6. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
  7. Patient with social insurance coverage

Exclusion Criteria:

  1. Confirmed metastatic disease at initial presentation
  2. Any contraindication to the biopsy procedure
  3. 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
  4. 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
  5. Individuals deprived of liberty or placed under the authority of a tutor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All included patients

Patients will undergo a biopsy and provide a blood sample prior to initiating standard neoadjuvant chemotherapy. Additional tissue samples will be collected at the following time points:

  1. (optional) biopsy of primary tumour after 4 cycles of neoadjuvant chemotherapy
  2. At the time of surgery (samples of the primary tumour and lymph nodes which are surplus to diagnostic requirements).
  3. Biopsy of a metastatic site in the event of disease recurrence.

Blood samples will be obtained during neoadjuvant chemotherapy, prior to surgery and at 6-month intervals for up to 5 years post-surgery. In the event of recurrent disease, blood samples will be collected i) at the time of recurrence, ii) at the first CT scan on treatment and iii) at each subsequent relapse for up to 5 years post-surgery.
Procedure: Biopsy
Biopsy of primary tumour to be performed prior to initiation of neoadjuvant chemotherapy
Procedure: Biopsy (optional)
[Optional] biopsy of primary tumour to be performed after 4 weeks of neoadjuvant chemotherapy
Procedure: Biopsy (metastatic)
Biopsy of metastatic site to be performed at the time of relapse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
pCR will be defined at the time of surgery on the tumor specimen

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from surgery until 5 years post-surgery
Overall survival
Time Frame: from surgery until 5 years post-surgery
the time from neoadjuvant treatment until death due to any cause
from surgery until 5 years post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Collaborators

National Cancer Institute, France

Investigators

  • Principal Investigator: Monica ARNEDOS, MD, Gustave Roussy Cancer Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2017

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 1, 2017

First Submitted That Met QC Criteria

March 10, 2017

First Posted (Actual)

March 13, 2017

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UC-0105/1614
  • ID RCB: 2016-A01177-44 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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