Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
T-DM1 · 1 trial · 1 indication
The number and type of DLTs as defined in the protocol that occur during the first 21 days of treatment and all maximum grade of all treatment-related adverse events using CTCAE v4.0 will be used to identify a safe and tolerable dose
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab Combine With Trastuzumab Emtansine | EXPERIMENTAL | * Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle * Pembrolizumab will be administered prior to T-DM1 administration * Pembrolizumab will be given at a predetermine dose * T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle * T-DM1 will be given at a predetermine dose |
| Name | Type | Description |
|---|---|---|
| T-DM1 | DRUG | -T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle |
| Pembrolizumab | DRUG | -Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle |
Inclusion Criteria: * Patients must have histologically or cytologically confirmed invasive breast cancer, with stage IV disease. Patients without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evalua...
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T-DM1 is an investigational small molecule being studied for the treatment of breast cancer. It is currently in Phase 1 clinical development. T-DM1 is being evaluated in combination with pembrolizumab in a clinical trial for patients with breast cancer.
T-DM1 is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting clinical research on T-DM1 for the treatment of breast cancer.
T-DM1 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial of T-DM1 in combination with pembrolizumab for breast cancer has been completed.
T-DM1 has been studied in one clinical trial, identified as NCT03032107. This was a Phase 1 study titled "A Study Of Pembrolizumab In Combination With Trastuzumab-DM1" in patients with breast cancer. The trial enrolled 20 participants and has been completed.
Yes, T-DM1 is also known as trastuzumab-DM1. The clinical trial NCT03032107 evaluated the combination of pembrolizumab with trastuzumab-DM1, which is the same drug as T-DM1, in patients with breast cancer.