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The scope of the trial is to identify proteomic signatures correlated with tumor response to neo-adjuvant chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FEC 100 + TAXOTERE | Experimental | FEC 100 = Fluoro-uracile + Epirubicin + Cyclophosphamide Fluoro-uracile : 500 mg/m²/cycle Epirubicin : 100 mg/m²/cycle Cyclophosphamide : 500 mg/m²/cyle 1 cycle = 21 days. For a total of 6 cycles or 3 cycles followed by 3 cycles of TAXOTERE TAXOTERE 100 mg/m²/cycle 1 cycle = 21 days. For a total of 3 cycles following 3 FEC 100 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Procedure | Taken at different times : inclusion, at the cycle 4 and at the cycle 6 during the neoadjuvant chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proteomic analysis by SELDI-TOF on the tumor biopsy and blood samples Histological response according To Chevallier and Sataloff | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation with node invasion | 6 months | |
| Correlation with basal, luminal phenotypes, HER2 status or hormonal status | 6 months | |
| Correlation with the response measured by ultrasound after chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| BONNETERRE Jacques, MD, PhD | Centre Oscar Lambret | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intercommunal Hospital | Annemasse | 74 107 | France | |||
| Centre Oscar Lambret |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D001706 | Biopsy |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| BIOPSY | Procedure | Biopsy at the moment of inclusion, before neoadjuvant chemotherapy |
|
| SURGERY | Procedure | Surgery after neoadjuvant chemotherapy |
|
| After 3 and 5 months |
| Lille |
| 59020 |
| France |
| Hopital Saint Vincent | Lille | 59020 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Geroges PIANTA Hospital | Thonon-les-Bains | 74 203 | France |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011677 | Punctures |
| D008919 | Investigative Techniques |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D003949 | Diagnostic Techniques, Surgical |