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epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| A | ACTIVE_COMPARATOR | Sequential Epidoxorubicin followed by CMF: ciclophosphamide/Methotrexate/fluorouracile (±TAM: tamoxifen) |
| B | EXPERIMENTAL | Sequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM) |
| C | EXPERIMENTAL | Sequential Intensified Epidoxorubicin followed by Docetaxel followed by Cyclophosphamide (± TAM) |
| Name | Type | Description |
|---|---|---|
| epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile | DRUG | Sequential Epidoxorubicin followed by ciclophosphamide/Methotrexate/fluorouracile (±TAM) |
| epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile | DRUG | Sequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM) |
| epidoxorubicine, docetaxel, cyclophosphamide | DRUG | Sequential Intensified Epidoxorubicin followed by Docetaxel followed by Cyclophosphamide (± TAM) |
Inclusion criteria: * Histologically proven breast cancer at the first diagnosis with \> or = 4 axillary nodes showing evidence of tumor among a minimum of 10 resected lymph nodes (American Joint Committee on Cancer 1992 pathologic staging pT1-4, pN1-2 \[at least 1/10\], M0) * Ages ≥ 18 years and ≤...
This combination regimen is used in the treatment of breast neoplasms. It combines four small molecule agents given together as a chemotherapy regimen. It has been studied in a Phase 3 trial in female breast cancer patients aged 18 years and older.
Sanofi, which trades under the ticker SNY, is the developer associated with this four-drug chemotherapy combination for breast neoplasms. The regimen has been evaluated in a Phase 3 clinical trial conducted in Italy.
This combination is in Phase 3 development for breast neoplasms. The Phase 3 trial has completed, and no trials of this regimen are currently active. It is an investigational regimen rather than an approved product.
The regimen was studied in NCT00174707, a Phase 3 trial titled Study of Docetaxel in Breast Cancer Patients. That trial enrolled 998 participants with breast neoplasms in Italy, was randomized and active controlled, and has completed.
NCT00174707 was a Phase 3, randomized, active-controlled trial that enrolled 998 female participants aged 18 years and older with breast neoplasms. It was conducted in Italy and has completed. The trial was not double blinded and did not use biomarker selection.