# Efficacy and Safety of the Combination of Trastuzumab Plus TUCAtinib Plus viNorelbine in Patients With HER2-positive Non-resectable Locally Advanced or Metastatic Breast Cancer

> **NCT05583110** · PHASE2 · TERMINATED · sponsor: **Spanish Breast Cancer Research Group** · enrollment: 13 (actual)

## Conditions studied

- HER2-positive Metastatic Breast Cancer
- Locally Advanced HER2 Positive Breast Carcinoma

## Interventions

- **DRUG:** Tucatinib
- **DRUG:** Trastuzumab
- **DRUG:** Vinorelbine

## Key facts

- **NCT ID:** NCT05583110
- **Lead sponsor:** Spanish Breast Cancer Research Group
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2023-03-08
- **Primary completion:** 2025-05-30
- **Final completion:** 2025-05-30
- **Target enrollment:** 13 (ACTUAL)
- **Why stopped:** The study was closed early due to safety concerns and an unfavorable benefit-risk balance. Unexpected high neutropenia rates required a costly sub-study, which was not feasible, forcing the sponsor to terminate the trial prematurely.
- **Last updated:** 2025-12-10

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05583110

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05583110, "Efficacy and Safety of the Combination of Trastuzumab Plus TUCAtinib Plus viNorelbine in Patients With HER2-positive Non-resectable Locally Advanced or Metastatic Breast Cancer". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT05583110. Licensed CC0.

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