Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Doxorubicine+ docetaxel sequential · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| A1 | ACTIVE_COMPARATOR | - |
| A2 | ACTIVE_COMPARATOR | - |
| B | EXPERIMENTAL | - |
| C | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Doxorubicine + docetaxel sequential | DRUG | doxorubicin 75 mg/m² i.v. day 1, q 21 days for 3 cycles, followed by docetaxel 100 mg/m² i.v., 1 hour infusion, day 1, q 21 days for 3 cycles, followed by CMF for 3 cycles |
| doxorubicine + cyclophosphamide sequential | DRUG | doxorubicin 75 mg/m² i.v. day 1 q 21 days for 4 cycles, followed by CMF (C: cyclophosphamide 100 mg/m² orally days 1-14, M: methotrexate: 40 mg/m² i.v. days 1 and 8, FU; 5-fluorouracil: 600 mg/m²) i.v. days 1 and 8, q 28 days for 3 cycles |
| doxorubicine + cyclophosphamide combined | DRUG | doxorubicin 60 mg/m² i.v. + cyclophosphamide 600 mg/m² i.v., day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles. |
| doxorubicine + docetaxel combined | DRUG | doxorubicin 50 mg/m² i.v. + docetaxel 75 mg/m² i.v. 1 hour infusion (1 hour after doxorubicin), day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles. |
Inclusion Criteria: * Histologically proven breast cancer. Interval between definitive surgery that includes axillary lymph node dissection and registration must be less than 60 days. A representative sample of the primary tumor (either blocks or slides) must be sent to the operational office, for ...
Doxorubicine plus docetaxel sequential is a chemotherapy regimen studied for breast neoplasms, also known as breast cancer. It combines two cytotoxic agents given one after the other rather than at the same time. The regimen was evaluated in a Phase 3 trial in women aged 18 years and older with breast cancer.
Doxorubicine targets TOP2A, topoisomerase II alpha, an enzyme involved in DNA replication and repair. It belongs to the inhibitor class against this target. Docetaxel acts on the microtubule apparatus of dividing cells. Together the two agents interfere with processes that cancer cells require to divide and survive.
Sanofi, which trades under the ticker SNY, is the developer associated with the doxorubicine plus docetaxel sequential regimen. The company sponsored the Phase 3 breast cancer study that evaluated this sequential chemotherapy approach.
Doxorubicine plus docetaxel sequential has been studied in Phase 3 clinical development for breast neoplasms. It is an investigational regimen rather than a standalone approved product. The single registered Phase 3 trial has completed, and no trials of this regimen are currently listed as active.
The regimen was evaluated in the BIG 02/98 Docetaxel - Breast Cancer trial, registered as NCT00174655. That Phase 3 study enrolled 2,887 participants across 21 countries, including Australia, Brazil, Germany, Italy, Spain, the United Kingdom and others. It was randomized, active controlled, restricted to female participants aged 18 years and older, and has completed.