Tracking Triple-negative Breast Cancer Evolution Through Therapy (TRACERX-TNBC)
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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
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Sponsor:
UNICANCER
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
UNICANCER
Tracking Information | |||||
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First Submitted Date ICMJE | March 1, 2017 | ||||
First Posted Date ICMJE | March 13, 2017 | ||||
Last Update Posted Date | April 20, 2020 | ||||
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 |
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)
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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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 | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Triple-Negative Breast Neoplasm | ||||
Intervention ICMJE |
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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:
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:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Suspended | ||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
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 ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | UNICANCER | ||||
Study Sponsor ICMJE | UNICANCER | ||||
Collaborators ICMJE | National Cancer Institute, France | ||||
Investigators ICMJE |
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PRS Account | UNICANCER | ||||
Verification Date | April 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |