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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00021255 | Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer | PHASE3 | COMPLETED | 3,222 | — | — | Apr 1, 2001 | Dec 1, 2014 | Nov 15, 2016 | 42 | United States, Argentina +40 |
Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.
| Arm | Type | Description |
|---|---|---|
| Doxorubicin+Cyclophosphamide (AC) followed by Docetaxel (AC→T) | EXPERIMENTAL | Doxorubicin 60 mg/m² intravenous (IV) bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles. |
| AC followed by Docetaxel + Herceptin (AC→TH) | EXPERIMENTAL | Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose. |
| Docetaxel + Carboplatin + Herceptin (TCH) | EXPERIMENTAL | Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose. |
| Name | Type | Description |
|---|---|---|
| Doxorubicin | DRUG | - |
| Cyclophosphamide | DRUG | - |
| Docetaxel | DRUG | - |
| Herceptin | DRUG | - |
| Carboplatin | DRUG | - |
Inclusion criteria: * Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the participants for treatment and follow-up. * Accessible for treatment and follow-up at participating centers. * Histologically proven breast cancer with an interval b...