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| ID | Type | Description | Link |
|---|---|---|---|
| ID RCB: 2016-A01177-44 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy | Procedure | Biopsy of primary tumour to be performed prior to initiation of neoadjuvant chemotherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | pCR will be defined at the time of surgery on the tumor specimen |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monica ARNEDOS, MD | Gustave Roussy Cancer Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Jean Perrin | Clermont-Ferrand | France | ||||
| Centre George François Leclerc |
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| Label | URL |
|---|---|
| UNICANCER official website | View source |
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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 |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Biopsy (optional) | Procedure | [Optional] biopsy of primary tumour to be performed after 4 weeks of neoadjuvant chemotherapy |
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| Biopsy (metastatic) | Procedure | Biopsy of metastatic site to be performed at the time of relapse |
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| from surgery until 5 years post-surgery |
| Overall survival | the time from neoadjuvant treatment until death due to any cause | from surgery until 5 years post-surgery |
| Dijon |
| France |
| Centre Leon Bérard | Lyon | France |
| Institut Paoli Calmettes | Marseille | France |
| Institut de Cancerologie de l'Ouest | Nantes | France |
| Centre Eugène Marquis | Rennes | France |
| Centre Paul Strauss | Strasbourg | France |
| Hopitaux universitaire de strasbourg - Hopital civil | Strasbourg | France |
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | France |
| Gustave Roussy | Villejuif | France |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |