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Lapatinib · 1 trial · 1 indication
Progression-free survival (PFS) by BICR was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Trastuzumab deruxtecan (DS-8201a) | EXPERIMENTAL | HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to treatment with DS-8201a |
| Trastuzumab+capecitabine | ACTIVE_COMPARATOR | HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Trastuzumab/capecitabine |
| Lapatinib+capecitabine | ACTIVE_COMPARATOR | HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Lapatinib/capecitabine |
| Name | Type | Description |
|---|---|---|
| Trastuzumab deruxtecan | DRUG | DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as intravenous (IV) dose |
| Capecitabine | DRUG | Investigator's choice Standard of Care when combined with trastuzumab or lapatinib |
| Lapatinib | DRUG | Investigator's choice Standard of Care when combined with capecitabine |
| Trastuzumab | DRUG | Investigator's choice Standard of Care when combined with capecitabine |
Inclusion Criteria: * Is the age of majority in their country * Has pathologically documented breast cancer that: 1. is unresectable or metastatic 2. has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guide...
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Lapatinib is an investigational small molecule being studied for the treatment of breast cancer. It is being evaluated in a Phase 3 clinical trial for patients with HER2-positive breast cancer that cannot be surgically removed or has spread. The drug is being developed by AstraZeneca PLC.
Lapatinib targets the HER2 receptor, which is a protein that promotes the growth of cancer cells. By inhibiting HER2, Lapatinib aims to slow or stop the growth of HER2-positive breast cancer. This targeted approach is being studied in a Phase 3 clinical trial for patients with advanced breast cancer.
Lapatinib is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the safety and efficacy of Lapatinib in patients with breast cancer.
Lapatinib is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial is designed to assess its efficacy and safety in patients with HER2-positive breast cancer that is advanced or metastatic.
Lapatinib is being studied in a Phase 3 clinical trial with the identifier NCT03523585. This trial, titled 'DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]', has been completed and enrolled 608 participants across multiple countries including the United States, Australia, and Japan.
Lapatinib is not the same as DS-8201a. The clinical trial NCT03523585 is evaluating DS-8201a, not Lapatinib. Lapatinib is a separate investigational drug being developed by AstraZeneca for breast cancer. The trial information provided does not indicate that Lapatinib has any alternative names.