Approval Probability
TA Base Rate
Adjusted LOA
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lapatinib ditosylate · 1 trial · 1 indication
Progression-free survival (PFS) is the time from randomization to the earliest date of RECIST 1.0 assessment of disease progression (with radiological evidence), death from any cause, or censoring. Disease progression was assessed by the Investigator and defined by RECIST v1.0 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions.
| Arm | Type | Description |
|---|---|---|
| Lapatinib | ACTIVE_COMPARATOR | Plus taxane based chemotherapy |
| Trastuzumab | ACTIVE_COMPARATOR | Plus taxane based chemotherapy. |
| Name | Type | Description |
|---|---|---|
| trastuzumab | BIOLOGICAL | IV q weekly (loading dose 4mg/kg; subsequent doses 2mg/kg) or IV q 3 weekly (loading dose 8mg/kg, subsequent doses 6mg/kg). |
| docetaxel | DRUG | 75mg/m2 IV q 3 weekly, day 1 of a 3 week cycle for 8 cycles plus G-CSF (when given together with lapatinib). |
| lapatinib ditosylate | DRUG | 1250 mg once daily (while given with taxane). 1500mg once daily (when given alone after taxane completion). |
| paclitaxel | DRUG | 80mg/m2 IV q weekly days 1, 8 and 15 of a 4-week cycle for 6 cycles. |
Key inclusion criteria: * Histologically confirmed adenocarcinoma of the breast. * MBC (stage IV) at primary diagnosis or at relapse after curative intent therapy. * Local or central laboratory confirmed HER2/neu overexpressing and/or amplified disease in the invasive component of the primary or me...
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Lapatinib ditosylate is an investigational small molecule being studied for the treatment of HER2/neu-positive metastatic breast cancer in women. It is being evaluated in combination with chemotherapy as a potential treatment option for this patient population.
Lapatinib ditosylate is being studied in patients with HER2/neu-positive metastatic breast cancer, indicating that it targets the HER2/neu pathway. The drug is designed to interfere with this specific molecular target in cancer cells.
Lapatinib ditosylate is being developed by Novartis AG, a global healthcare company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate the drug's safety and efficacy in breast cancer.
Lapatinib ditosylate is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to determine its safety and effectiveness in treating HER2/neu-positive metastatic breast cancer.
Lapatinib ditosylate has one completed Phase 3 clinical trial registered under NCT00667251. This trial enrolled 652 women with HER2/neu-positive metastatic breast cancer and compared chemotherapy combined with either lapatinib ditosylate or trastuzumab across multiple countries.
Lapatinib ditosylate is a specific salt form of the drug lapatinib. The ditosylate salt is the formulation used in clinical development, and it is the active pharmaceutical ingredient being studied in the Phase 3 trial for HER2/neu-positive metastatic breast cancer.