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Label indication TYKERB ® is indicated in combination with: capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. FDA label
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 studied for breast cancer. It has been evaluated in HER2/Neu-positive metastatic breast cancer, where it was compared with trastuzumab alongside chemotherapy. The clinical program focuses on biomarker-selected patients whose tumors express the relevant receptor target.
Lapatinib ditosylate targets EGFR and ERBB2, also known as HER2. It is an inhibitor of these receptor tyrosine kinases, which are involved in signaling that drives tumor cell growth in breast cancer. Targeting both receptors is intended to block that signaling in ERBB2-positive disease.
Lapatinib ditosylate is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor associated with the clinical development program for this small molecule in breast cancer.
Lapatinib ditosylate is in Phase 3 clinical development. It is investigational and has not been established as approved for breast cancer. The Phase 3 trial in HER2/Neu-positive metastatic breast cancer has completed, and no active trials are currently listed for this asset.
Lapatinib ditosylate has been studied in the completed Phase 3 trial NCT00667251, titled Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer. The trial enrolled 652 women aged 18 and older across the United States, Europe, Asia, and other regions, with an active-controlled design.