WHO ICTRP trial
Study to know the usefulness of Trastuzumab Emtansine medicine in widespread…
CTRI/2019/08/020544 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2019/08/020544 |
|---|---|
| Public title | Study to know the usefulness of Trastuzumab Emtansine medicine in widespread breast cancer patients |
| Scientific title | A Randomized, Multiple-dose, Multicenter, Comparative Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetic Characteristics of Intravenous Infusion of Trastuzumab Emtansine (Hetero) and Reference Medicinal Product (Trastuzumab Emtansine, Roche) in Patients of HER2- positive Metastatic… |
| Primary sponsor | Hetero Biopharma Limited |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 3 |
| Countries | India |
| Conditions | Health Condition 1: C509- Malignant neoplasm of breast of unspecified site |
| Interventions | Intervention1: Trastuzumab Emtansine (Hetero) (T): Test product will be administered 3.6 mg/kg given as an intravenous infusion every 3 weeks (21-day cycle) for 8 cycles or until disease progression (PD) (as assessed by the (investigator)… |
| Registration date | May 8, 2019 |
| Target size | 153 |
| Secondary IDs | HCR/III/TREMBC/11/2016; Version 1.0 dated 25 Nov 2016 |
| Registry page | ctri.nic.in |
At a glance
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: