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Also known as PLD
PLD, cyclophosphamide, trastuzumab, paclitaxel · 1 trial · 1 indication
Cardiac events defined as: Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of \>10 percentage points from baseline and to ≤50% LVEF Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of \>10 percentage points from baseline and to \<50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks.
| Arm | Type | Description |
|---|---|---|
| Doxorubicin Based Regimen | ACTIVE_COMPARATOR | - |
| Pegylated Liposomal Doxorubicin (PLD) Based Regimen | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| doxorubicin, cyclophosphamide, paclitaxel, trastuzumab | DRUG | doxorubicin 60 mg/m\^2 IV push + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses) |
| PLD, cyclophosphamide, trastuzumab, paclitaxel | DRUG | PLD 35 mg/m\^2 IV over 60 minutes + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses) |
Inclusion Criteria: * Subjects with operable, node-positive or high-risk node-negative (see #3 below) HER2-positive breast carcinoma are eligible for the study, provided they satisfy the following criteria. * Subjects must demonstrate willingness to and be able to participate in the study and to...
PLD, cyclophosphamide, trastuzumab, and paclitaxel is a combination regimen being studied for the treatment of breast neoplasm, specifically as adjuvant therapy for HER2-positive breast cancer. It is an investigational combination of small molecule drugs and trastuzumab, and it is not yet approved by the FDA.
PLD, cyclophosphamide, trastuzumab, and paclitaxel is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical research on this combination regimen for the treatment of breast cancer.
PLD, cyclophosphamide, trastuzumab, and paclitaxel is in Phase 2 clinical development. It has completed one Phase 2 trial, and it remains an investigational combination regimen, meaning it has not received FDA approval and is still being evaluated in clinical studies.
PLD, cyclophosphamide, trastuzumab, and paclitaxel has one completed clinical trial, NCT00550771, titled 'Phase II Trial to Compare the Safety of Two Chemotherapy Plus Trastuzumab Regimens as Adjuvant Therapy for HER2-positive Breast Cancer (Study P05048)'. This trial enrolled 181 female participants aged 18 years and older.
Yes, PLD, cyclophosphamide, trastuzumab, and paclitaxel is also known as PLD. This alternative name is used in clinical research and references to the combination regimen, which is being studied for the treatment of HER2-positive breast cancer.