Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Liposomal doxorubicin · 1 trial · 1 indication
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...
Top 20 of 92 competitors
Liposomal doxorubicin is being studied for the treatment of breast cancer, specifically in HER2-positive breast cancer. It is an investigational small molecule in Phase 2 clinical development. The drug is being evaluated in combination therapy for this patient population.
Liposomal doxorubicin is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with HER2-positive breast cancer.
Liposomal doxorubicin is in Phase 2 clinical development for breast cancer. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, with results expected to inform further development.
Liposomal doxorubicin has one completed clinical trial, NCT00712881, titled "Combination Therapy With MYOCET® (Doxorubicin HCL Liposome for Injection) in Participants With HER2-Positive Breast Cancer." This Phase 2 trial enrolled 126 female participants across Austria, Belgium, France, Germany, Italy, and Spain.
Yes, Liposomal doxorubicin is also known as MYOCET, which is the brand name used in clinical trials. The trial NCT00712881 refers to the drug as MYOCET (Doxorubicin HCL Liposome for Injection), confirming that these names refer to the same investigational agent.