Approval Probability
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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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Epidoxorubicin is an oncology drug that has been studied in breast cancer. Roche Holding AG developed it, and clinical testing has focused on patients with inflammatory or locally advanced breast cancer. It is a small molecule therapeutic, and the recorded development stage for this asset is Phase 2.
Epidoxorubicin is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor associated with the clinical program for this asset in breast cancer. The drug is a small molecule in the oncology therapeutic area.
Epidoxorubicin is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently recorded for this asset. It is an investigational agent and is not described as approved. The completed study enrolled 56 patients.
Epidoxorubicin has been evaluated in one completed Phase 2 trial, NCT00559845, titled A Study of Avastin (Bevacizumab) in Patients With Inflammatory or Locally Advanced Breast Cancer. The study enrolled 56 female patients aged 18 years and older in Italy. It was uncontrolled, non-randomized, and not double-blind.
Epidoxorubicin has been studied in breast cancer, specifically in patients with inflammatory or locally advanced disease. The completed Phase 2 trial NCT00559845 enrolled 56 female patients aged 18 years and older in Italy. The study was uncontrolled and did not use randomization or double-blinding.