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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00129935 | EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer | PHASE3 | COMPLETED | 1,384 | — | — | Feb 1, 2004 | Apr 4, 2019 | Mar 31, 2023 | 58 | Spain |
A participant was considered to have had a DFS event if there was evidence of local, regional or metastatic recurrence, second primary cancer (with the exception of carcinoma of squamous cells or basal cells of the skin, cervical carcinoma in situ or lobular or ductal carcinoma in situ of the breast) or death for any reason.
| Arm | Type | Description |
|---|---|---|
| Arm A: EC-T | ACTIVE_COMPARATOR | Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles. |
| Arm B: ET-X | EXPERIMENTAL | Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles. |
| Name | Type | Description |
|---|---|---|
| Docetaxel | DRUG | - |
| Capecitabine | DRUG | - |
| Epirubicin | DRUG | - |
| Cyclophosphamide | DRUG | - |
Inclusion Criteria: * Written informed consent. * Histological diagnosis of operable invasive adenocarcinoma of the breast (T1-T3). Tumours must be HER2 negative. Time window between surgery and study randomization must be less than 60 days. * Surgery must consist of mastectomy or conservative surg...