Triple-Negative Breast NeoplasmTRACERX-TNBCNCT03077776
Tracking Triple-negative Breast Cancer Evolution Through Therapy
A study testing Biopsy, Biopsy (optional) and Biopsy (metastatic) in people with Triple-Negative Breast Neoplasm, run by UNICANCER at 10 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple-Negative Breast Neoplasm
- What is being tested?
- Biopsy, Biopsy (optional) and Biopsy (metastatic)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 10 sitesFrance
- Study dates
- 14 Apr 2017to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Centre Jean Perrin
Clermont-Ferrand
Centre George François Leclerc
Dijon
Centre Leon Bérard
Lyon
Institut Paoli Calmettes
Marseille
Institut de Cancerologie de l'Ouest
Nantes
Centre Eugène Marquis
Rennes
Centre Paul Strauss
Strasbourg
Hopitaux universitaire de strasbourg - Hopital civil
Strasbourg
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy
Gustave Roussy
Villejuif
About this study
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.
- Conditions
- Triple-Negative Breast Neoplasm
- Being tested
- Biopsy, Biopsy (optional), Biopsy (metastatic)
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Biopsy of primary tumour to be performed prior to initiation of neoadjuvant chemotherapy
Biopsy (optional)Procedure or surgery
[Optional] biopsy of primary tumour to be performed after 4 weeks of neoadjuvant chemotherapy
Biopsy (metastatic)Procedure or surgery
Biopsy of metastatic site to be performed at the time of relapse
| Study group | Role | What they receive |
|---|---|---|
| All included patients | Experimental | 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. Receives: Procedure: Biopsy; Procedure: Biopsy (optional); Procedure: Biopsy (metastatic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: pCR will be defined at the time of surgery on the tumor specimen
Secondary outcomes (2)
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.
Measured: from surgery until 5 years post-surgery
Overall survival
the time from neoadjuvant treatment until death due to any cause
Measured: from surgery until 5 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start14 Apr 2017
- Primary completion1 Jun 2024
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-Negative Breast NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Monica ARNEDOS, MD, Principal investigator, Gustave Roussy Cancer Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077776
- Sponsor's protocol ID
- UC-0105/1614
- Other IDs
- ID RCB: 2016-A01177-44
- Acronym
- TRACERX-TNBC
- Status last verified
- Jul 2026
- First submitted
- 1 Mar 2017
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking Triple-negative Breast Cancer Evolution Through Therapy
- ClinicalTrials.gov ID
- NCT03077776
- Acronym / sponsor ID
- TRACERX-TNBC / UC-0105/1614
- Conditions
- Triple-Negative Breast Neoplasm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 149 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- 14 Apr 2017 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 13 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All included patients | Experimental | Procedure: Biopsy, Procedure: Biopsy (optional), Procedure: Biopsy (metastatic)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyBiopsy of primary tumour to be performed prior to initiation of neoadjuvant chemotherapy | Procedure or surgery | All included patients |
| Biopsy (optional)[Optional] biopsy of primary tumour to be performed after 4 weeks of neoadjuvant chemotherapy | Procedure or surgery | All included patients |
| Biopsy (metastatic)Biopsy of metastatic site to be performed at the time of relapse | Procedure or surgery | All included patients |
Primary outcome
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)
2 secondary outcomes
Invasive disease-free survival
Time frame: from surgery until 5 years post-surgery
Overall survival
Time frame: from surgery until 5 years post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- UNICANCER official websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Triple-Negative Breast Neoplasm
RecruitingObservational study
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor, Adult, Colorectal Cancer
Active, not recruitingPhase 3
Testing MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer
Breast Carcinoma In Situ, Invasive Breast Carcinoma
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Not yet recruitingPhase 1
A Study to Evaluate YF550 in Participants With Locally Advanced or Metastatic Solid Tumors.
Solid Tumor (Phase I), Ovarian Cancer
RecruitingPhase 1
A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs
Triple Negative Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica ARNEDOS, MD principal investigator
Gustave Roussy Cancer Campus
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy, Biopsy (optional) and Biopsy (metastatic) in people with Triple-Negative Breast Neoplasm, run by UNICANCER at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of pathological complete response (pCR) (time frame: pCR will be defined at the time of surgery on the tumor specimen). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.