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A correlation between early changes in the tumor maximum standardized uptake value (SUVmax) on FDG-PET after one or two cycles of neoadjuvant chemotherapy (NAC) and the pathological response after 6 to 8 cycles has been demonstrated in several independent small series of patients.
Breast tumor proliferation status has previously been demonstrated to be a good predictive factor of response to chemotherapy. The best method for assessing proliferation status is unclear. Proportion of cells staining for nuclear Ki67 antigen is the most widely used assay for comparing the proliferation status between tumors. However major variations in analytical procedure and interpretation limited its clinical value. Taking into account the prognosis and predictive value of proliferation gene as a common "signature" in breast cancer transcriptome analysis, quantitative assessment of mRNA expression of genes involved in proliferation has been developed by the investigators team and others. The evaluation of these parameters is quantitative and reliable and can be standardized for a clinical use.
The main objective of the investigators study is to early predict pathological response to anthracycline-based neoadjuvant chemotherapy (NAC) using a combination of parameters based on FDG-PET imaging performed at baseline and after 2 cycles, and molecular markers of proliferation measured on pre-treatment biopsy (Ki67 protein level by immunohistochemistry and Ki67 mRNA level and the mRNA (messenger RNA) expression of the most pertinent genes of the Genomic Grade Index (GGI) component by RT (reverse transcriptase) - qPCR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| main and unique cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non interventional study | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response to anthracycline-based neoadjuvant chemotherapy |
| Within the first 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 5 years | |
| Overall Survival | 3 years | |
| Event Free survival |
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Inclusion Criteria:
Exclusion Criteria:
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Stage II-III Breast cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia de Cremoux, MD-PhD | Contact | 142499388 | +33 | patricia.de-cremoux@aphp.fr |
| David Groheux, MD-PhD | Contact | 142499411 | david.groheux@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Ingrid Veron | DRCD | Study Chair |
| Patricia de Cremoux, MD-PhD | APHP, IUH, University Paris Diderot, Paris 7, SPC | Principal Investigator |
| David Groheux, MD-PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital siant-Louis | Recruiting | Paris | Paris | 75010 | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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somatic molecular analyses
To determine the 5 years Event free survival (EFS) rates in breast cancer patients according to PET response, biological markers and biomarkers identified with molecular high throughput analysis.
| 5 years |
| Event Free survival | To determine the 3 years Event free survival (EFS) rates in breast cancer patients according to PET response, biological markers and biomarkers identified with molecular high throughput analysis. | 3 years |
| Breast Cancer specific survival | To determine the 5 years Breast Cancer Specific survival rates in breast cancer patients according to PET response, biological markers and biomarkers identified with molecular high throughput analysis. | 5 years |
| Breast Cancer specific survival | To determine the 3 years Breast Cancer Specific survival rates in breast cancer patients according to PET response, biological markers and biomarkers identified with molecular high throughput analysis. | 3 years |
| Pathological partial response to anthracycline-based neoadjuvant chemotherapy |
| Within the first 30 days after surgery |
| Delta SUV | To evaluate the correlation between baseline molecular status of proliferation and FDG uptake measured at baseline, after 2 cycles of NAC and the change (delta SUV). | Within the first 20 days after the second cycle of chemotherapy |
| APHP, IUH, University Paris Diderot, Paris 7, SPC |
| Principal Investigator |
| D017437 |
| Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |