Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pegylated liposomal doxorubicin · 1 trial · 1 indication
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective response (OR) = CR + PR.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Patients will receive IV Doxil 30 mg/m2 and carboplatin AUC=5 on Day 1 of each cycle. A cycle consists of 28 days. In addition, HER2+ (IHC3+ and FISH+) patients only will receive a one-time loading dose of Herceptin 8 mg/kg IV on Day 1 of Cycle 1 and 4 mg/kg on Day 1 and Day 15 of every cycle thereafter. |
| Name | Type | Description |
|---|---|---|
| Pegylated liposomal doxorubicin | DRUG | 30 mg/m2 IV on Day 1 of each 28 day cycle |
| Carboplatin | DRUG | AUC=5 on Day 1 of each 28 day cycle |
| trastuzumab | DRUG | 4 mg/kg on Days 1 and 15 of each cycle(loading dose of 8 mg/kg on Day 1 of Cycle 1 only) |
Inclusion Criteria: * Has metastatic breast cancer with documented HER2- or HER2+ (IHC3+ or FISH+) disease * Has measurable MBC, with at least 1 measurable lesion per RECIST criteria (see Section 10). Irradiated lesions cannot be used to assess response but can be used to assess progression. * Has ...
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Pegylated liposomal doxorubicin is used for metastatic breast cancer. It is a small molecule oncology drug being studied in a Phase 2 clinical trial for this condition. The drug is also known as Doxil in the context of the trial.
Pegylated liposomal doxorubicin is being developed by McKesson Corporation, which trades under the ticker MCK. The company is conducting clinical research on this drug for metastatic breast cancer.
Pegylated liposomal doxorubicin is in Phase 2 clinical development. It is an investigational drug for metastatic breast cancer and is not yet approved by regulatory authorities. The Phase 2 trial has been completed.
Pegylated liposomal doxorubicin is associated with clinical trial NCT00303108, titled "Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer." This Phase 2 trial enrolled 136 participants in the United States and has been completed.
Yes, pegylated liposomal doxorubicin is the same as Doxil. The clinical trial NCT00303108 uses the name Doxil to refer to this drug. It is being studied in combination with carboplatin for HER2-positive metastatic breast cancer.