Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Trastuzumab-Pfizer
PF-05280014 · 2 trials · 2 indications
The percentage of participants with Cycle 5 Ctrough (Cycle 6 pre-dose) \>20 μg/mL in each treatment group, the denominator being the number of participants in the per protocol population for each treatment group.
ORR was defined as the percentage of participants who achieved complete response (CR, complete disappearance of all target lesions with the exception of nodal disease; all target nodes must have decreased to normal size \[short axis \<10 mm\]) or partial response (PR, \>=30% decrease from baseline of the sum of diameters (SOD) of all target measurable lesions; the short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions) by Week 25 of the study and confirmed on a follow-up assessment (Week 33+/-14 days), based on the assessments of the central radiology review in accordance with RECIST 1.1.
| Arm | Type | Description |
|---|---|---|
| PF-05280014 | EXPERIMENTAL | - |
| Herceptin® | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PF-05280014 | BIOLOGICAL | Concentrate for solution for infusion, sterile vial 150 mg, Day 1 Cycle 1 will be a loading dose of 8 mg/kg infused over 90 minutes. Subsequent infusions will follow every 3 weeks (i.e., cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability, maximum of 6 cycles. |
| Taxotere® | DRUG | Injection concentrate single-dose vials containing 20 mg (0.5 mL) or 80 mg (2 mL), each mL contains 40 mg docetaxel (anhydrous) and 1040 mg polysorbate 80, The starting dose of Taxotere® (docetaxel) will be 75 mg/m2 administered intravenously over 60 minutes every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles. |
| Paraplatin® | DRUG | Lyophilized powder, single-dose vials containing 50 mg, 150 mg, and 450 mg of Carboplatin for administration by intravenous infusion (each vial contains equal parts by weight of Carboplatin and mannitol), starting dose 6 AUC, over 15 minutes or longer every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles. |
| Trastuzumab-EU | BIOLOGICAL | Concentrate for solution for infusion, sterile vial 150 mg, Day 1 Cycle 1 will be a loading dose of 8 mg/kg infused over 90 minutes. Subsequent infusions will follow every 3 weeks (i.e., cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability, maximum 6 cycles. |
| Paclitaxel | DRUG | A nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel. The starting dose of paclitaxel will be 80 mg/m\^2 by IV infusion over 60 minutes (duration of infusion may be modified according to local standard of care, if applicable). Provision is made for dose reduction to 70 mg/m\^2 and then 60 mg/m\^2 as needed. In the absence of disease progression in the judgment of the investigator or prohibitive toxicity, patients will receive treatment with paclitaxel for at least 6 cycles or until maximal benefit of response is obtained, in the judgment of the investigator. |
| Herceptin® | BIOLOGICAL | Concentrate for solution for infusion, sterile vial 150 mg. Initial dose of 4 mg/kg over 90 minutes (depending on tolerability) IV infusion, then 2 mg/kg over 30 to 90 minutes (depending on tolerability) IV infusion weekly until disease progression. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the Herceptin® regimen may be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability. |
Inclusion Criteria: * Histologically confirmed HER2 overexpressing invasive breast cancer. * Plan for definitive surgical resection of breast tumor (i.e., lumpectomy or mastectomy, and sentinel node (SN) biopsy or axillary lymph node dissection (ALND). * Plan for neoadjuvant chemotherapy. * Measura...
PF-05280014 is being developed for the treatment of HER2-positive breast cancer, including early breast cancer in the neoadjuvant setting and metastatic breast cancer in the first-line setting. It is a monoclonal antibody studied in combination with chemotherapy agents such as taxotere, carboplatin, and paclitaxel.
PF-05280014 is a monoclonal antibody that targets HER2, a protein overexpressed in certain breast cancers. By binding to HER2, it is designed to inhibit the growth of HER2-positive tumor cells. The drug is being studied specifically in biomarker-selected HER2-positive breast cancer patients.
PF-05280014 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. Pfizer is the sponsor of the clinical trials evaluating this monoclonal antibody in breast cancer.
PF-05280014 is in Phase 3 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 3 program includes completed trials in early and metastatic HER2-positive breast cancer.
PF-05280014 has been studied in two completed Phase 3 trials: NCT02187744, which evaluated it with taxotere and carboplatin in early HER2-positive breast cancer, and NCT01989676, which tested it with paclitaxel in first-line metastatic HER2-positive breast cancer. Both trials were randomized, double-blind, and active-controlled.
PF-05280014 is also known as trastuzumab-Pfizer. It is a proposed biosimilar to trastuzumab, referencing Herceptin. The clinical trials directly compared PF-05280014 with trastuzumab (Herceptin) to evaluate similarity in efficacy and safety.