Conditions: Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 126
Healthy volunteers: no

Brief summary:
To evaluate the efficacy and safety of treatment with MYOCET® (doxorubicin hydrochloride) in combination with cyclophosphamide and trastuzumab, 4 cycles, followed by docetaxel plus trastuzumab, 4 cycles, in women with stage II or III breast cancer whose tumour overexpresses the human epidermal growth factor receptor 2 (HER2) gene.

Detailed description:

Arms:
arm 1: 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 \[6 mg/kg\]). arm 2: 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.

Interventions: intervention 1: Liposomal doxorubicin hydrochloride intervention 2: Cyclophosphamide intervention 3: Trastuzumab intervention 4: Free doxorubicin hydrochloride intervention 5: Docetaxel
Intervention descriptions: intervention 1: Liposomal doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description. intervention 2: Cyclophosphamide will be administered per dose and schedule specified in the arm description. intervention 3: Trastuzumab will be administered per dose and schedule specified in the arm description. intervention 4: Free doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description. intervention 5: Docetaxel will be administered per dose and schedule specified in the arm description.

Protocol document: