Triple-negative Breast Cancer (TNBC)PRIME-TNBCNCT07570524
Predicting Response to Immunochemotherapy in Early Triple Negative Breast Cancer
An observational study of Triple-negative Breast Cancer (TNBC), run by Center Eugene Marquis at 1 site in France.
Trial summary
The goal of this clinical trial is to identify cellular and molecular determinants of response to neoadjuvant immunochemotherapy in women aged 18 or older with early-stage triple-negative breast cancer (TNBC). 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 (TNBC)
- What is being tested?
- Additionnal breast biospy and blood sample
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2026to 25 Jun 2036
- Phase
- Observational
- 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
Study population: Patients treated in the neoadjuvant setting for triple-negative breast cancer
Who may be able to join
- Female.
- Age ≥ 18 years.
- Histologically confirmed invasive triple-negative breast cancer (ER and PR < 10% by IHC, HER2 0, 1+, or 2+ with negative SISH), stage II or III.
- Eligible for neoadjuvant immunochemotherapy according to the Keynote-522 regimen.
- Indication for intra-tumoral clip placement.
- Signed written informed consent
Who cannot join
- Pregnant or breastfeeding women.
- Hematoma requiring Grade II analgesics after diagnostic biopsy.
- Known coagulation disorders.
- Adults under guardianship, curatorship, or legal protection, or deprived of liberty.
- Not affiliated with a social security system.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Eugène Marquis
Rennes, 35000
Antoine DELEUZE, Dr, a.deleuze@rennes.unicancer.fr
About this study
The goal of this clinical trial is to identify cellular and molecular determinants of response to neoadjuvant immunochemotherapy in women aged 18 or older with early-stage triple-negative breast cancer (TNBC). The main questions it aims to answer are:
- Can detailed immune profiling of the tumor and its microenvironment predict pathological complete response (pCR, RCB-0) versus partial/non-response (RCB-I, II, III) to neoadjuvant immunochemotherapy?
- Are there specific immune or molecular biomarkers (e.g., TILs, CD3/8/20, FoxP3, PDL1, transcriptomic signatures) associated with progression-free survival and overall survival in this population? Researchers will compare patients achieving pCR (RCB-0) to those with residual disease (RCB-I, II, III) to determine if immune and molecular profiles can discriminate responders from non-responders and guide personalized treatment strategies.
- Conditions
- Triple-negative Breast Cancer (TNBC)
- Being tested
- Additionnal breast biospy and blood sample
- Keywords
- Biopsy, Residual Cancer Burden score
- 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.
Additionnal breast biospy and blood sampleBiological
Tumor biopsy during intra-tumoral clip placement (pre-treatment) and annual blood samples (20 mL) for 5 years, in addition to standard follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Triple Negative Breast Cancer | The study will include an initial assessment and longitudinal and individual follow-up to identify the occurrence of clinical events of interest and to monitor the evolution of any tumour biomarkers on circulating tumour DNA. Receives: Biological: Additionnal breast biospy and blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Immune Determinants According to Response to Neoadjuvant Immunochemotherapy
Comparison of immune determinants (cellular and molecular) in tumor and blood samples between patients achieving pathological complete response (pCR, RCB-0) and those with partial/non-response (RCB-I, II, III).
Measured: Baseline (pre-treatment tumor biopsy) and up to 5 years (annual blood samples and clinical follow-up).
Comparison of Immune Determinants According to Progression-Free Survival (PFS)
omparison of immune determinants between patients with different progression-free survival (PFS) outcomes. PFS is defined as the time from the start of neoadjuvant treatment to the first occurrence of tumor recurrence, evaluated according to RECIST v1.1 criteria.
Measured: From baseline (pre-treatment) through 5 years of follow-up.
Comparison of Immune Determinants According to Overall Survival (OS)
Comparison of immune determinants between patients with different overall survival (OS) outcomes. OS is defined as the time from the start of neoadjuvant treatment to death from any cause.
Measured: From baseline (pre-treatment) through 5 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start25 Jun 2026
- Primary completion25 Jun 2036 (estimated)
- Study completion25 Jun 2036 (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 Cancer (TNBC)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine DELEUZE, Dr, Principal investigator, Centre de lutte contre le cancer Eugène Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570524
- Sponsor's protocol ID
- 2025-4-83-004
- Acronym
- PRIME-TNBC
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Response to Immunochemotherapy in Early Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07570524
- Acronym / sponsor ID
- PRIME-TNBC / 2025-4-83-004
- Conditions
- Triple-negative Breast Cancer (TNBC)
- Keywords
- Biopsy, Residual Cancer Burden score
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- 25 Jun 2036 (estimated)
- Study completion
- 25 Jun 2036 (estimated)
- First posted
- 6 May 2026 (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.
The goal of this clinical trial is to identify cellular and molecular determinants of response to neoadjuvant immunochemotherapy in women aged 18 or older with early-stage triple-negative breast cancer (TNBC). The main questions it aims to answer are:
- Can detailed immune profiling of the tumor and its microenvironment predict pathological complete response (pCR, RCB-0) versus partial/non-response (RCB-I, II, III) to neoadjuvant immunochemotherapy?
- Are there specific immune or molecular biomarkers (e.g., TILs, CD3/8/20, FoxP3, PDL1, transcriptomic signatures) associated with progression-free survival and overall survival in this population? Researchers will compare patients achieving pCR (RCB-0) to those with residual disease (RCB-I, II, III) to determine if immune and molecular profiles can discriminate responders from non-responders and guide personalized treatment strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triple Negative Breast Cancer | – | Biological: Additionnal breast biospy and blood sampleThe study will include an initial assessment and longitudinal and individual follow-up to identify the occurrence of clinical events of interest and to monitor the evolution of any tumour biomarkers on circulating tumour DNA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated in the neoadjuvant setting for triple-negative breast cancer
Key inclusion criteria (6 listed)
- Female.
- Age ≥ 18 years.
- Histologically confirmed invasive triple-negative breast cancer (ER and PR < 10% by IHC, HER2 0, 1+, or 2+ with negative SISH), stage II or III.
- Eligible for neoadjuvant immunochemotherapy according to the Keynote-522 regimen.
- Indication for intra-tumoral clip placement.
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women.
- Hematoma requiring Grade II analgesics after diagnostic biopsy.
- Known coagulation disorders.
- Adults under guardianship, curatorship, or legal protection, or deprived of liberty.
- Not affiliated with a social security system.
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 |
|---|---|---|
| Additionnal breast biospy and blood sampleTumor biopsy during intra-tumoral clip placement (pre-treatment) and annual blood samples (20 mL) for 5 years, in addition to standard follow-up. | Biological | Triple Negative Breast Cancer |
Primary outcome
Comparison of Immune Determinants According to Response to Neoadjuvant Immunochemotherapy
Time frame: Baseline (pre-treatment tumor biopsy) and up to 5 years (annual blood samples and clinical follow-up).
Comparison of immune determinants (cellular and molecular) in tumor and blood samples between patients achieving pathological complete response (pCR, RCB-0) and those with partial/non-response (RCB-I, II, III).
Comparison of Immune Determinants According to Progression-Free Survival (PFS)
Time frame: From baseline (pre-treatment) through 5 years of follow-up.
omparison of immune determinants between patients with different progression-free survival (PFS) outcomes. PFS is defined as the time from the start of neoadjuvant treatment to the first occurrence of tumor recurrence, evaluated according to RECIST v1.1 criteria.
Comparison of Immune Determinants According to Overall Survival (OS)
Time frame: From baseline (pre-treatment) through 5 years of follow-up
Comparison of immune determinants between patients with different overall survival (OS) outcomes. OS is defined as the time from the start of neoadjuvant treatment to death from any cause.
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 10 Jul 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.
Antoine DELEUZE, Dr principal investigator
Centre de lutte contre le cancer Eugène Marquis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Triple-negative Breast Cancer (TNBC), run by Center Eugene Marquis 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 6 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: looking for participants now, as of the sponsor's last update on 10 Jul 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?
Contact Valérie JOLAINE (0299253036 ext. +33, v.jolaine@rennes.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Immune Determinants According to Response to Neoadjuvant Immunochemotherapy (time frame: Baseline (pre-treatment tumor biopsy) and up to 5 years (annual blood samples and clinical follow-up).). The study lists 3 primary outcomes in all. 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 10 Jul 2026.