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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00544765 | Docetaxel, Doxorubicin and Cyclophosphamide Versus Vinorelbine and Capecitabine in Patients Not Sufficiently / Sufficiently Responding as Preoperative Treatment of Locally Advanced or Operable Primary Breast Cancer | PHASE3 | COMPLETED | 2,014 | — | — | Sep 1, 2002 | Feb 1, 2008 | Feb 4, 2021 | - | — |
To determine the iRR rate of 4 cycles of docetaxel, doxorubicin and cyclophosphamide (TAC) and of 4 cycles of vinorelbine and capecitabine (NX) (TAC-NX) as a salvage treatment
| Arm | Type | Description |
|---|---|---|
| resp: 4xTAC | EXPERIMENTAL | Patients sufficiently responding (iPR, iCR) will recieve 4 further cycles of TAC |
| resp: 6xTAC | EXPERIMENTAL | Patients sufficiently responding (iPR, iCR) will recieve 6 further cycles of TAC |
| nonResp: 4xTAC | EXPERIMENTAL | Patients non-sufficiently responding (iNC) will recieve 4 further cycles of TAC |
| nonResp: 4xNX | EXPERIMENTAL | Patients non-sufficiently responding (iNC) will recieve 4 further cycles of NX |
| Name | Type | Description |
|---|---|---|
| TAC | DRUG | Docetaxel 75 mg/m² as a 1 hour i.v. infusion on day 1 every 3 weeks in combination with Doxorubicin 50 mg/m² as an i.v. bolus and Cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks |
| NX | DRUG | Vinorelbine 25 mg/m² as a \< 10 min i.v. infusion on days 1 and 8 repeated every 3 weeks and Capecitabine 2000 mg/m² orally in 2 daily doses on days 1-14 repeated every 3 weeks |
Inclusion Criteria: * Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures. * Complete baseline documentation sent to SKM CRS. * Unilateral or bilateral primary carcinoma of the breast, confirmed hist...