Triple-negative Breast CancerTNBC-RT2023NCT06418126
Prediction of Radiotherapy Efficacy in Patients With Triple-negative Breast Cancer
A study testing blood sampling before radiotherapy, blood sampling after the fourth radiotherapy session and collection of acute toxicity (radiodermatitis) in people with Triple-negative Breast Cancer, run by Centre Paul Strauss at 1 site in France.
Trial summary
Recurrence of triple-negative breast cancer (TNBC) occurs in around 30% of patients within 3 years of treatment. For some TNBC patients, recurrence occurs on average 2.6 years after treatment, while for others recurrence does not occur early. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple-negative Breast Cancer
- What is being tested?
- blood sampling before radiotherapy, blood sampling after the fourth radiotherapy session and collection of acute toxicity (radiodermatitis)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2024to 19 Aug 2030
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with TNBC breast cancer who meet the following criteria:
- Women aged 18 and over;
- Any tumor size (pT stage);
- Regional lymph node pN0 to pN3;
- Patient with pathologically confirmed TNBC (estrogen and progesterone receptor negative and HER2 negative);
- Neo- or adjuvant chemotherapy followed by radiotherapy;
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- No evidence of distant metastasis at time of diagnosis;
- Primary tumor removed by conservative surgery with negative margins;
- Patient covered by the French social security system (for French patients).
Who cannot join
- Distant metastasis at the time of diagnosis;
- Pregnant or breast-feeding women;
- Woman deprived of liberty, under guardianship or trusteeship.
- Patient unable to give consent
- Patient unable to speak French
- Patients unable to undergo regular long-term surveillance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Radiotherapy Efficacy in Patients With Triple-negative Breast Cancer : TNBC-RT2023
Recurrence of triple-negative breast cancer (TNBC) occurs in around 30% of patients within 3 years of treatment. For some TNBC patients, recurrence occurs on average 2.6 years after treatment, while for others recurrence does not occur early. TNBC patients can therefore be divided into two groups: those with early recurrence and those who respond well to treatment.
At present, there are no biomarkers to differentiate these two groups. Some studies suggest that radiation-induced inflammatory cytokines may stimulate the development of new metastases. Gene expression profiling or protein signatures have not been able to define such biomarkers.
The aim of this research protocol is to recruit patients to evaluate if the elevation of the cytokines IL-1β, IL-5 and IL-6 in plasma collected during radiotherapy can be used to predict TNBC patients at high risk of recurrence.
- Conditions
- Triple-negative Breast Cancer
- Being tested
- blood sampling before radiotherapy, blood sampling after the fourth radiotherapy session, collection of acute toxicity (radiodermatitis), collection of late toxicity, collection of disease status
- Keywords
- Radiotherapy
- 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.
blood sampling before radiotherapyBiological
A blood sample (20 ml) will be taken prior to radiotherapy
blood sampling after the fourth radiotherapy sessionBiological
A blood sample (20 ml) will be taken immediately after the 4th radiotherapy session.
collection of acute toxicity (radiodermatitis)Other
for the entire duration of radiotherapy
collection of late toxicityOther
every year for 5 years
collection of disease statusOther
throughout the study
Radiotherapy - Breast +/- lymph node areasRadiation
40.05 Gy in 15 fractions of 2.67 Gy, one fraction per week, 5 days per week Or 50 Gy in 25 fractions of 2 Gy, one fraction per week, 5 days per week
Radiotherapy - Boost operating bedRadiation
10 Gy in 4 fractions of 2.5 Gy, one fraction per week, 5 days per week Or 16 Gy in 8 fractions of 2 Gy, one fraction per week, 5 days per week
| Study group | Role | What they receive |
|---|---|---|
| Women with TNBC breast cancer | Experimental | Patients will be recruited before the start of radiotherapy. A blood sample (20 ml) will be taken before radiotherapy and immediately after the 4th radiotherapy session.
They will be followed up annually for 5 years after the end of treatment, to determine whether their cancer has recurred. Receives: Biological: blood sampling before radiotherapy; Biological: blood sampling after the fourth radiotherapy session; Other: collection of acute toxicity (radiodermatitis); Other: collection of late toxicity; Other: collection of disease status; Radiation: Radiotherapy - Breast +/- lymph node areas; Radiation: Radiotherapy - Boost operating bed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of recurrence associated with the appearance of inflammatory cytokines
Determine whether TNBC patients who respond poorly to radiotherapy can be identified by the appearance of inflammatory cytokines in the blood during radiotherapy.
Measured: up to 5 years
Secondary outcomes (2)
To determine whether the increased invasive capacity of TNBC cells incubated with plasma collected during radiotherapy will be associated with recurrence.
TNBC cells will be incubated with plasma collected before or during radiotherapy. Boyden chambers will be used to determine the increase in cell invasion.
Measured: up to 5 years
To determine whether the development of metastases in a mouse model injected with TNBC D2A1 cells pre-incubated with plasma collected during radiotherapy will be associated with recurrence.
Number and sizes of metastases to the lungs will be determined after i.v. plasma injection in Balb/c mice.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start11 Jan 2024
- Primary completion7 Oct 2025
- Study completion19 Aug 2030 (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 CancerStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418126
- Sponsor's protocol ID
- 2023-003
- Acronym
- TNBC-RT2023
- Status last verified
- Dec 2025
- First submitted
- 11 Apr 2024
- Last updated
- 5 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Radiotherapy Efficacy in Patients With Triple-negative Breast Cancer : TNBC-RT2023
- ClinicalTrials.gov ID
- NCT06418126
- Acronym / sponsor ID
- TNBC-RT2023 / 2023-003
- Conditions
- Triple-negative Breast Cancer
- Keywords
- Radiotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Collaborators
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 7 Oct 2025 (actual)
- Study completion
- 19 Aug 2030 (estimated)
- First posted
- 16 May 2024 (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.
Recurrence of triple-negative breast cancer (TNBC) occurs in around 30% of patients within 3 years of treatment. For some TNBC patients, recurrence occurs on average 2.6 years after treatment, while for others recurrence does not occur early. TNBC patients can therefore be divided into two groups: those with early recurrence and those who respond well to treatment.
At present, there are no biomarkers to differentiate these two groups. Some studies suggest that radiation-induced inflammatory cytokines may stimulate the development of new metastases. Gene expression profiling or protein signatures have not been able to define such biomarkers.
The aim of this research protocol is to recruit patients to evaluate if the elevation of the cytokines IL-1β, IL-5 and IL-6 in plasma collected during radiotherapy can be used to predict TNBC patients at high risk of recurrence.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with TNBC breast cancer | Experimental | Biological: blood sampling before radiotherapy, Biological: blood sampling after the fourth radiotherapy session, Other: collection of acute toxicity (radiodermatitis), Other: collection of late toxicity, Other: collection of disease status, Radiation: Radiotherapy - Breast +/- lymph node areas, Radiation: Radiotherapy - Boost operating bedPatients will be recruited before the start of radiotherapy. A blood sample (20 ml) will be taken before radiotherapy and immediately after the 4th radiotherapy session. They will be followed up annually for 5 years after the end of treatment, to determine whether their cancer has recurred. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Women aged 18 and over;
- Any tumor size (pT stage);
- Regional lymph node pN0 to pN3;
- Patient with pathologically confirmed TNBC (estrogen and progesterone receptor negative and HER2 negative);
- Neo- or adjuvant chemotherapy followed by radiotherapy;
Key exclusion criteria (6 listed)
- Distant metastasis at the time of diagnosis;
- Pregnant or breast-feeding women;
- Woman deprived of liberty, under guardianship or trusteeship.
- Patient unable to give consent
- Patient unable to speak French
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 |
|---|---|---|
| blood sampling before radiotherapyA blood sample (20 ml) will be taken prior to radiotherapy | Biological | Women with TNBC breast cancer |
| blood sampling after the fourth radiotherapy sessionA blood sample (20 ml) will be taken immediately after the 4th radiotherapy session. | Biological | Women with TNBC breast cancer |
| collection of acute toxicity (radiodermatitis)for the entire duration of radiotherapy | Other | Women with TNBC breast cancer |
| collection of late toxicityevery year for 5 years | Other | Women with TNBC breast cancer |
| collection of disease statusthroughout the study | Other | Women with TNBC breast cancer |
| Radiotherapy - Breast +/- lymph node areas40.05 Gy in 15 fractions of 2.67 Gy, one fraction per week, 5 days per week Or 50 Gy in 25 fractions of 2 Gy, one fraction per week, 5 days per week | Radiation | Women with TNBC breast cancer |
| Radiotherapy - Boost operating bed10 Gy in 4 fractions of 2.5 Gy, one fraction per week, 5 days per week Or 16 Gy in 8 fractions of 2 Gy, one fraction per week, 5 days per week | Radiation | Women with TNBC breast cancer |
Primary outcome
Predictive value of recurrence associated with the appearance of inflammatory cytokines
Time frame: up to 5 years
Determine whether TNBC patients who respond poorly to radiotherapy can be identified by the appearance of inflammatory cytokines in the blood during radiotherapy.
2 secondary outcomes
To determine whether the increased invasive capacity of TNBC cells incubated with plasma collected during radiotherapy will be associated with recurrence.
Time frame: up to 5 years
To determine whether the development of metastases in a mouse model injected with TNBC D2A1 cells pre-incubated with plasma collected during radiotherapy will be associated with recurrence.
Time frame: up to 5 years
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 5 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling before radiotherapy, blood sampling after the fourth radiotherapy session and collection of acute toxicity (radiodermatitis) in people with Triple-negative Breast Cancer, run by Centre Paul Strauss at 1 site 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 9 inclusion and 6 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 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Predictive value of recurrence associated with the appearance of inflammatory cytokines (time frame: up to 5 years). 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 5 Jan 2026.