Tracking Triple-negative Breast Cancer Evolution Through Therapy (TRACERX-TNBC)
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| ClinicalTrials.gov Identifier: NCT03077776 |
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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
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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 |
| 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 Genetics related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
| Arm | Intervention/treatment |
|---|---|
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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. |
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 :
- 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 :
- 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
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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:
- 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
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
| 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
| Principal Investigator: | Monica ARNEDOS, MD | Gustave Roussy Cancer Campus |
Additional Information:
| 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 |
| 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 |