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

Primary Purpose

Triple-Negative Breast Neoplasm

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biopsy
Biopsy (optional)
Biopsy (metastatic)
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Triple-Negative Breast Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Jean Perrin
  • Centre George François Leclerc
  • Centre Leon Bérard
  • Institut Paoli Calmettes
  • Institut de Cancerologie de l'Ouest
  • Centre Eugène Marquis
  • Centre Paul Strauss
  • Hopitaux universitaire de strasbourg - Hopital civil
  • Institut de Cancérologie de Lorraine
  • Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All included patients

Arm Description

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: (optional) biopsy of primary tumour after 4 cycles of neoadjuvant chemotherapy At the time of surgery (samples of the primary tumour and lymph nodes which are surplus to diagnostic requirements). 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.

Outcomes

Primary Outcome Measures

Rate of pathological complete response (pCR)
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 Outcome Measures

Invasive disease-free survival
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.
Overall survival
the time from neoadjuvant treatment until death due to any cause

Full Information

First Posted
March 1, 2017
Last Updated
March 22, 2023
Sponsor
UNICANCER
Collaborators
National Cancer Institute, France
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1. Study Identification

Unique Protocol Identification Number
NCT03077776
Brief Title
Tracking Triple-negative Breast Cancer Evolution Through Therapy
Acronym
TRACERX-TNBC
Official Title
Tracking Triple-negative Breast Cancer Evolution Through Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 14, 2017 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER
Collaborators
National Cancer Institute, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple-Negative Breast Neoplasm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All included patients
Arm Type
Experimental
Arm Description
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: (optional) biopsy of primary tumour after 4 cycles of neoadjuvant chemotherapy At the time of surgery (samples of the primary tumour and lymph nodes which are surplus to diagnostic requirements). 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.
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Intervention Description
Biopsy of primary tumour to be performed prior to initiation of neoadjuvant chemotherapy
Intervention Type
Procedure
Intervention Name(s)
Biopsy (optional)
Intervention Description
[Optional] biopsy of primary tumour to be performed after 4 weeks of neoadjuvant chemotherapy
Intervention Type
Procedure
Intervention Name(s)
Biopsy (metastatic)
Intervention Description
Biopsy of metastatic site to be performed at the time of relapse
Primary Outcome Measure Information:
Title
Rate of pathological complete response (pCR)
Description
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)
Time Frame
pCR will be defined at the time of surgery on the tumor specimen
Secondary Outcome Measure Information:
Title
Invasive disease-free survival
Description
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.
Time Frame
from surgery until 5 years post-surgery
Title
Overall survival
Description
the time from neoadjuvant treatment until death due to any cause
Time Frame
from surgery until 5 years post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica ARNEDOS, MD
Organizational Affiliation
Gustave Roussy Cancer Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
Country
France
Facility Name
Centre George François Leclerc
City
Dijon
Country
France
Facility Name
Centre Leon Bérard
City
Lyon
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
Country
France
Facility Name
Institut de Cancerologie de l'Ouest
City
Nantes
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
Country
France
Facility Name
Hopitaux universitaire de strasbourg - Hopital civil
City
Strasbourg
Country
France
Facility Name
Institut de Cancérologie de Lorraine
City
Vandœuvre-lès-Nancy
Country
France
Facility Name
Gustave Roussy
City
Villejuif
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://www.unicancer.fr/
Description
UNICANCER official website

Learn more about this trial

Tracking Triple-negative Breast Cancer Evolution Through Therapy

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