Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Epidoxorubicin · 1 trial · 1 indication
Pathological complete response was defined as absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy.
| Arm | Type | Description |
|---|---|---|
| Bevacizumab | EXPERIMENTAL | Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months. |
| Name | Type | Description |
|---|---|---|
| 5-fluorouracil | DRUG | 600 milligrams per meter squared (mg/m\^2) as an intravenous (i.v.) bolus over ≤15 minutes every 3 weeks for 4 cycles. |
| Epidoxorubicin | DRUG | 90 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles. |
| Cyclophosphamide | DRUG | 600 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles. |
| Paclitaxel | DRUG | Paclitaxel was administered at 80 mg/m\^2 i.v. over 1 hour weekly for 12 weeks. |
| Bevacizumab | BIOLOGICAL | Bevacizumab was administered at 10 milligrams per kilogram (mg/kg) i.v. every 2 weeks for 6 cycles. |
Inclusion Criteria: * female participants, \>=18 years of age; * stage III, or inflammatory breast cancer; * estrogen receptor/progesterone receptor (ER/PgR) positive or negative and human epidermal growth factor receptor 2 (HER-2) negative; * normal left ventricular ejection fraction (LVEF). Excl...
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