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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Additionnal breast biospy and blood sample | Biological | Tumor biopsy during intra-tumoral clip placement (pre-treatment) and annual blood samples (20 mL) for 5 years, in addition to standard follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | From baseline (pre-treatment) through 5 years of follow-up |
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Inclusion Criteria:
Indication for intra-tumoral clip placement.
- Signed written informed consent
Exclusion Criteria:
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Patients treated in the neoadjuvant setting for triple-negative breast cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valérie JOLAINE | Contact | 0299253036 | +33 | v.jolaine@rennes.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Antoine DELEUZE, Dr | Centre de lutte contre le cancer Eugène Marquis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Eugène Marquis | Recruiting | Rennes | 35000 | France |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |