Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01690702 | Study of Nab-Paclitaxel in High Risk Early Breast Cancer | PHASE3 | COMPLETED | 2,886 | — | — | Sep 1, 2012 | Jul 20, 2020 | Feb 2, 2021 | 1 | Germany |
| NCT00072319 | Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer | PHASE2 | COMPLETED | - | — | — | Aug 1, 2003 | Nov 1, 2006 | Mar 4, 2013 | 1 | United States |
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.
| 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 |
| Name | Type | Description |
|---|---|---|
| Epirubicin | DRUG | - |
| nab-Paclitaxel | DRUG | - |
| Cyclophosphamide | DRUG | - |
| Docetaxel | DRUG | - |
| filgrastim | BIOLOGICAL | - |
| epirubicin hydrochloride | DRUG | - |
| paclitaxel | DRUG | - |
| adjuvant therapy | PROCEDURE | - |
| neoadjuvant therapy | PROCEDURE | - |
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...