WHO ICTRP trial
A study of tucatinib versus placebo in combination with pertuzumab and…
EUCTR2021-002491-39-PT · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2021-002491-39-PT |
|---|---|
| Public title | A study of tucatinib versus placebo in combination with pertuzumab and trastuzumab for subjects with advanced or metastatic HER2+ breast cancer |
| Scientific title | A randomized, double-blind, phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for metastatic HER2+ breast cancer (HER2CLIMB-05) - HER2CLIMB-05 |
| Primary sponsor | Seagen Inc. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;Portugal;Taiwan;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Poland;Australia;Germany;China;Japan;Korea, Republic of |
| Conditions | Unresectable locally-advanced or metastatic HER2+ breast cancer MedDRA version: 23.0 Level: PT Classification code 10065430 Term: HER2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl… |
| Interventions | Trade Name: TUKYSA Product Name: Tucatinib Product Code: ONT-380 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Tucatinib CAS Number: 1429755-56-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration… |
| Registration date | Dec 21, 2021 |
| Target size | 650 |
| Secondary IDs | SGNTUC-028;2021-002491-39-FR |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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: