An observational study in Triple-negative Breast Cancer (TNBC), sponsored by Center Eugene Marquis. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Center Eugene Marquis · Observational
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:
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 446 are open to participants now.
This study's planned enrollment of 200 is close to the median of 193 across 106 observational studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →Center Eugene Marquis is the lead sponsor of 32 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated in the neoadjuvant setting for triple-negative breast cancer
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Indication for intra-tumoral clip placement.
- Signed written
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: Additionnal breast biospy and blood sample
Tumor biopsy during intra-tumoral clip placement (pre-treatment) and annual blood samples (20 mL) for 5 years, in addition to standard follow-up.
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).
Time frame: 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.
Time frame: 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.
Time frame: From baseline (pre-treatment) through 5 years of follow-up
Started Jun 2026 (actual). Primary completion is estimated for Jun 2036, 120 months after the start.
How these figures are worked out, and which studies are left out of them.
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