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T-DM1 · 1 trial · 1 indication
The primary objective is to show that pre-treatment 89Zr-trastuzumab PET/CT is able to select lesions not responding morphologically from treatment with T-DM1 (applying RECIST 1.0 criteria).
| Arm | Type | Description |
|---|---|---|
| T-DM1 | OTHER | After an imaging phase, the patient will receive T-DM1 iv every 3 weeks until progression or toxicity |
| Name | Type | Description |
|---|---|---|
| T-DM1 | DRUG | 3.6 mg/kg iv every 3 weeks |
| 89Zr-trastuzumab | PROCEDURE | Injection of 89Zr-trastuzumab for HER2 imaging |
Inclusion Criteria: 1. The patient must have histologically confirmed HER2 positive invasive carcinoma of the breast in the reference laboratory of the participating center. HER2 positive criteria to be applied are those used in the participating countries: * Belgium: FISH amplification ratio ≥...
T-DM1 is an investigational small molecule being studied for the treatment of HER-2 positive breast cancer. It is currently in Phase 2 clinical development. The drug is being evaluated in patients with HER-2 positive metastatic breast cancer, specifically to identify those who are unlikely to benefit from treatment.
T-DM1 targets HER-2, a protein that is overexpressed in certain types of breast cancer. The drug is designed to interact with HER-2 positive tumors, and its development includes biomarker-selected patient populations. This targeted approach is being studied in the context of HER-2 positive metastatic breast cancer.
T-DM1 is being developed by Roche Holding AG, a company traded under the ticker symbol RHHBY. Roche is conducting clinical trials to evaluate the drug's efficacy in patients with HER-2 positive breast cancer. The development program is currently in Phase 2.
T-DM1 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for its potential use in HER-2 positive breast cancer, with one completed Phase 2 trial involving 90 patients.
T-DM1 has been studied in one clinical trial, identified as NCT01565200. This Phase 2 trial, titled "HER2 Imaging Study to Identify HER2 Positive Metastatic Breast Cancer Patient Unlikely to Benefit From T-DM1," was completed and enrolled 90 participants. The study was conducted in Belgium and the Netherlands.
T-DM1 is also known as ado-trastuzumab emtansine. This alternative name is used in some contexts to refer to the same drug. The drug is being developed by Roche for the treatment of HER-2 positive breast cancer and is currently in Phase 2 clinical trials.