Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer (HER2CLIMB-02)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514733-38-00

Acronym

SGNTUC-016

Enrollment

101

Registered

2024-07-18

Start date

2020-11-03

Completion date

Unknown

Last updated

2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable locally-advanced or metastatic HER2+ breast cancer

Brief summary

PFS per RECIST v1.1, as determined by investigator assessment

Detailed description

OS, PFS.BM per RECIST v1.1, as determined by investigator assessment, ORR per RECIST v1.1, by investigator assessment, OS.BM

Interventions

DRUGTucatinib 50mg placebo tablets

DRUGTUKYSA 50 mg film-coated tablets

DRUGKadcyla 160 mg powder for concentrate for solution for infusion.

DRUGTucatinib 150mg placebo tablets

DRUGTUKYSA 150 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS per RECIST v1.1, as determined by investigator assessment	—

Secondary

Measure	Time frame
OS, PFS.BM per RECIST v1.1, as determined by investigator assessment, ORR per RECIST v1.1, by investigator assessment, OS.BM	—

Countries

Belgium, Denmark, France, Germany, Italy, Netherlands, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026