Clinical Trials

Several active clinical trials are currently recruiting patients to evaluate trastuzumab emtansine (T-DM1) in breast cancer and HER2-positive breast cancer across second-line therapy and residual invasive disease settings. These investigations include Phase 2 protocols and observational initiatives assessing real-world safety, effectiveness, and therapeutic interception of molecular residual disease. Key sponsors conducting these studies include Hoffmann-La Roche, University Health Network Toronto, and Consorzio Oncotech in collaboration with Roche Pharma AG.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05945927 Recruiting
Breast Cancer
Hoffmann-La Roche
 2023-09-13 --
NCT05388149 Recruiting
Breast Cancer|HER2-positive Breast Cancer
University Health Network Toronto
 2022-12-06 Phase 2
NCT05754502 Recruiting
Breast Cancer
Consorzio Oncotech|Roche Pharma AG
 2021-07-27 --

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Trastuzumab-Emtansine（T-DM1） product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Trastuzumab emtansine (T-DM1) selectively binds to human epidermal growth factor receptor 2 (HER2) on tumor cell surfaces, facilitating receptor-mediated endocytosis and lysosomal release of the cytotoxic maytansinoid DM1 to disrupt microtubule assembly. This destruction of microtubule networks leads to mitotic arrest and cell death, providing the biochemical basis for tumor growth inhibition in HER2-positive breast cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.