OncRef

Clinical Trial: NCT04539938

A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:Seagen, a wholly owned subsidiary of Pfizer
Information Provided By:Seagen Inc.
Last Update Posted:2026-03-23

Study Overview

Brief Summary

This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan (T-DXd). It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer.

Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and T-DXd.

Official Title

A Single Arm, Open Label Phase 2 Study of Tucatinib in Combination With Trastuzumab Deruxtecan in Subjects With Previously Treated Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer

Conditions

HER2 Positive Breast Cancer

Intervention / Treatment

  • Drug: tucatinib
  • Drug: trastuzumab deruxtecan

Other Study ID Numbers

  • SGNTUC-025
  • C4251006

Start Date (Actual)

2020-12-01

Primary Completion Date (Actual)

2024-07-15

Study Completion Date (Actual)

2025-03-07

Enrollment (Actual)

70

Study Type

Interventional

Phase

Phase 2