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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03077776
Recruitment Status : Suspended (Temporary suspension since March 13 due to COVID-19 pandemic)
First Posted : March 13, 2017
Last Update Posted : April 20, 2020
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
UNICANCER

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.

Condition or disease Intervention/treatment Phase
Triple-Negative Breast Neoplasm Procedure: Biopsy Procedure: Biopsy (optional) Procedure: Biopsy (metastatic) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Tracking Triple-negative Breast Cancer Evolution Through Therapy
Actual Study Start Date : April 14, 2017
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077776


Locations
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France
Centre Jean Perrin
Clermont-Ferrand, France
Centre George François Leclerc
Dijon, France
Centre Leon Bérard
Lyon, France
Institut Paoli Calmettes
Marseille, France
Institut de Cancerologie de l'Ouest
Nantes, France
Centre Eugène Marquis
Rennes, France
Centre Paul Strauss
Strasbourg, France
Hopitaux universitaire de strasbourg - Hopital civil
Strasbourg, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Gustave Roussy
Villejuif, France
Sponsors and Collaborators
UNICANCER
National Cancer Institute, France
Investigators
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Principal Investigator: Monica ARNEDOS, MD Gustave Roussy Cancer Campus
Additional Information:
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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT03077776    
Other Study ID Numbers: UC-0105/1614
ID RCB: 2016-A01177-44 ( Other Identifier: ANSM )
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Triple Negative Breast Neoplasms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases