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Trial Summary

This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.
Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).
In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in.
All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.

Acronym:

HER2CLIMB-05

ACTRN/NCT /ethics:

NCT05132582

Scientific title:

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

Sponsor / Cooperative group:

Seagen Inc.

Trial & Patient Characteristics

Cancer TypeBreast
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexAll
Tumour Stream -
Cancer StageMetastatic or Widespread
Anticipated Start Date2022-03-07
Anticipated End Date2027-06-30

Participating Hospitals

HospitalCancer Research SA
Clinical Trial CoordinatorKelly Mead/Kate Penta
Emailadmin@cancerresearchsa.com.au
Phone08 8359 2565
Principal InvestigatorDr Meena Okera
Recruitment StatusRecruiting