OncRef

Clinical Trial: NCT05132582

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Seagen, a wholly owned subsidiary of Pfizer
Information Provided By:Seagen Inc.
Last Update Posted:2026-09-29

Study Overview

Brief 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.

Official 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)

Conditions

HER2 Positive Breast Cancer

Intervention / Treatment

  • Drug: Tucatinib
  • Drug: Trastuzumab
  • Drug: Pertuzumab
  • Drug: Combination product: Trastuzumab + Pertuzumab
  • Drug: Placebo

Other Study ID Numbers

  • SGNTUC-028
  • C4251007
  • 2023-503826-37-00
  • 2023

Start Date (Actual)

2022-03-07

Primary Completion Date (Actual)

2025-09-05

Study Completion Date (Estimated)

2027-09-28

Enrollment (Actual)

654

Study Type

Interventional

Phase

Phase 3