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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00712881 | Combination Therapy With MYOCET® (Doxorubicin HCL Liposome for Injection) in Participants With HER2-Positive Breast Cancer | PHASE2 | COMPLETED | 126 | — | — | Oct 13, 2008 | Sep 17, 2015 | Feb 23, 2024 | 22 | Austria, Belgium +4 |
The pCR of breast was based upon histologic examination, as confirmed by a central panel of experts, of resected tissue .
| Arm | Type | Description |
|---|---|---|
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | EXPERIMENTAL | Participants will receive MCH (liposomal doxorubicin hydrochloride \[60 milligrams {mg}/square meter {m\^2}\], cyclophosphamide (600 mg/m\^2), and trastuzumab (8 or 6 mg/kilogram {kg}), administered as intravenous (IV) infusion on Day 1 of each of 4 consecutive 21-day cycles. For the first cycle, the loading dose of trastuzumab will be 8 mg/kg; 6 mg/kg will be used for the remaining cycles. After 4 cycles of MCH, the treatment will be changed to 4 consecutive 21-day cycles of TH (docetaxel \[100 mg/m\^2\] and trastuzumab \[6 mg/kg\]). |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | ACTIVE_COMPARATOR | Participants will receive AC (free doxorubicin hydrochloride \[60 mg/m\^2\] and cyclophosphamide \[600 mg/m\^2\]), administered as IV infusion on Day 1 of each of 4 consecutive 21-day cycles. After 4 cycles of AC, the treatment will be changed to 4 consecutive 21-day cycles of TH (docetaxel \[100 mg/m\^2\] and trastuzumab \[8 or 6 mg/kg\]). For the first cycle, the loading dose of trastuzumab will be 8 mg/kg; 6 mg/kg will be used for the remaining cycles. |
| Name | Type | Description |
|---|---|---|
| Liposomal doxorubicin hydrochloride | DRUG | Liposomal doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description. |
| Cyclophosphamide | DRUG | Cyclophosphamide will be administered per dose and schedule specified in the arm description. |
| Trastuzumab | DRUG | Trastuzumab will be administered per dose and schedule specified in the arm description. |
| Free doxorubicin hydrochloride | DRUG | Free doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description. |
| Docetaxel | DRUG | Docetaxel will be administered per dose and schedule specified in the arm description. |
Main Inclusion Criteria: * Treatment-naive participants with stage II or III invasive breast cancer (proven histologically/cytologically) and with tests showing an overexpressing of HER2. * Participants have at least 1 bidimensionally measurable lesion according to the World Health Organization (WH...