Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Epirubicin · 3 trials · 4 indications
The IDFS is defined as the time period between the registration and the first invasive event. It will be analyzed after the end of the study by referring to data from GBG patient's registry.
at the time of final surgery after 6 cycles of Arm A (Epirubicin/ Docetaxel/ Capecitabine-containing chemotherapy ± Trastuzumab in HER-2 positive disease) vs. Arm B (Epirubicin/Docetaxel-containing chemotherapy ± Trastuzumab in HER-2 positive disease).
| Arm | Type | Description |
|---|---|---|
| dtEC-dtD | ACTIVE_COMPARATOR | Epirubicin and Cyclophosphamide with a tailored dose 4 cycles q2w followed by one additional week followed by Docetaxel with a tailored dose 4 cycles q2w. |
| EnPC | EXPERIMENTAL | Epirubicin 150mg/qm 3 cycles q2w followed by nabPaclitaxel 260-330mg/qm (to be determined in run-in-phase) 3 cycles q2w followed by Cyclophosphamide 2000mg/qm 3 cycles q2w |
| A (experimental group) | ACTIVE_COMPARATOR | Epirubicin/Docetaxel/Capecitabine-containing chemotherapy ± trastuzumab in HER-2 positive disease |
| B (control group) | ACTIVE_COMPARATOR | Epirubicin/Docetaxel-containing chemotherapy ± trastuzumab in HER-2 positive disease |
| Phase 2 Arm C | PLACEBO_COMPARATOR | AMG 102 placebo plus ECX |
| Phase 1b | OTHER | Phase 1b dose study with open-labe AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed. |
| Phase 2 Arm B | ACTIVE_COMPARATOR | AMG 102 at 7.5mg/kg plus ECX |
| Phase 2 Arm A | ACTIVE_COMPARATOR | AMG 102 at 15mg/kg plus ECX |
| Name | Type | Description |
|---|---|---|
| Epirubicin | DRUG | - |
| nab-Paclitaxel | DRUG | - |
| Cyclophosphamide | DRUG | - |
| Docetaxel | DRUG | - |
| Capecitabine | DRUG | 6 cycles 1000mg/m2 oral, day 1-14 q2d |
| Trastuzumab | DRUG | cycle 1: 8mg/kg i.v. day 1 cycle 2-6: 6mg/kg i.v. day 1 (=6 cycles q3w) |
| AMG 102 | DRUG | Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment. |
| Cisplatin | DRUG | Administered day 1 of each cycle at 60mg/m2 IV. |
| Placebo | DRUG | AMG 102 placebo will be provided in similar vials as clear, colorless, sterile protein-free solution |
Inclusion Criteria: 1. Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures. 2. Histologically confirmed unilateral or bilateral primary carcinoma of the breast. 3. Age at diagnosis at least 18 years, female, an...
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Epirubicin is an oncology small molecule being studied for stomach neoplasms, breast cancer, and esophagogastric junction adenocarcinoma. It is currently in Phase 3 clinical development. Epirubicin is being evaluated in combination with other agents in clinical trials for these cancer types.
Epirubicin is being developed by Amgen Inc., which trades under the ticker AMGN. The company is conducting clinical trials to evaluate the drug in oncology indications including breast cancer and gastric cancers.
Epirubicin is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in completed Phase 3 trials for early breast cancer and in earlier-phase trials for gastric and esophagogastric junction cancers.
Epirubicin has been studied in several completed trials. NCT00309556 was a Phase 3 randomized neoadjuvant study in early breast cancer. NCT00719550 was a Phase 1 trial combining epirubicin with AMG 102 for gastric or esophagogastric junction cancer. NCT01234324 was a Phase 2 trial of epirubicin with panitumumab in gastric cancer. NCT01690702 was a Phase 3 study in high-risk early breast cancer.
Epirubicin is a small molecule oncology drug. Its specific molecular target is not disclosed in the available clinical trial information. The drug is being studied in combination with other therapies for the treatment of breast cancer and gastric cancers.
No, Epirubicin is not the same as AMG 102. In clinical trial NCT00719550, epirubicin was combined with AMG 102, which is a separate investigational agent. Epirubicin is the chemotherapy drug being evaluated in that trial, while AMG 102 is the experimental combination partner.