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

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ClinicalTrials.gov Identifier: NCT03077776
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : October 16, 2019
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
UNICANCER

Tracking Information
First Submitted Date  ICMJE March 1, 2017
First Posted Date  ICMJE March 13, 2017
Last Update Posted Date October 16, 2019
Actual Study Start Date  ICMJE April 14, 2017
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03077776 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
  • 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.
  • Overall survival [ Time Frame: from surgery until 5 years post-surgery ]
    the time from neoadjuvant treatment until death due to any cause
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tracking Triple-negative Breast Cancer Evolution Through Therapy
Official Title  ICMJE Tracking Triple-negative Breast Cancer Evolution Through Therapy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Triple-Negative Breast Neoplasm
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.

Interventions:
  • Procedure: Biopsy
  • Procedure: Biopsy (optional)
  • Procedure: Biopsy (metastatic)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 10, 2017)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2025
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marta JIMENEZ +33 (0)1 44 23 55 58 m-jimenez@unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03077776
Other Study ID Numbers  ICMJE UC-0105/1614
ID RCB: 2016-A01177-44 ( Other Identifier: ANSM )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party UNICANCER
Study Sponsor  ICMJE UNICANCER
Collaborators  ICMJE National Cancer Institute, France
Investigators  ICMJE
Principal Investigator: Monica ARNEDOS, MD Gustave Roussy Cancer Campus
PRS Account UNICANCER
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP