# HER2CLIMB-05

Source: https://onco.cc/trials/her2climb-05/  
OnCo record `her2climb-05` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

In HER2CLIMB-05, adding the brain-penetrant pill tucatinib to maintenance antibodies after first-line chemotherapy delayed progression by more than eight months.

## Summary

HER2CLIMB-05, trial NCT05132582 sponsored by Pfizer and reported at SABCS 2025, showed that adding the brain-penetrant tablet tucatinib to maintenance trastuzumab and pertuzumab after first-line induction chemotherapy for HER2-positive metastatic breast cancer delayed progression by more than eight months. It randomised 654 women to tucatinib or placebo with the two antibodies after taxane induction and met its primary progression-free survival endpoint with a benefit consistent across brain metastasis and hormone receptor subgroups, offering a chemotherapy-free intensification of maintenance. OnCo links it to tucatinib, trastuzumab and pertuzumab, and the result is consistent with HER2CLIMB. Overall survival is pending, and its place against first-line trastuzumab deruxtecan plus pertuzumab from DESTINY-Breast09 is unsettled, which is the open question. Tucatinib has its own page.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT05132582
- Phase: 3
- Setting: First-line HER2+ metastatic breast cancer after induction with taxane + trastuzumab + pertuzumab: maintenance tucatinib + HP vs placebo + HP
- Sponsor: Pfizer
- Enrolled: 654
- Result: PFS 24.9 vs 16.3 months, HR 0.64.
- Outcomes: Progression-free survival: Tucatinib + trastuzumab + pertuzumab 24.9 months vs Placebo + trastuzumab + pertuzumab 16.3 months, HR 0.641
- Replication: Consistent with HER2CLIMB; OS pending.

## Sources

- ClinicalTrials.gov NCT05132582: https://clinicaltrials.gov/study/NCT05132582
- JCO: https://ascopubs.org/doi/10.1200/JCO-25-02600

## Connected records

- cancers: [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/), [HER2-positive breast cancer with brain metastases](https://onco.cc/cancers/her2-positive-breast-brain-metastases/)
- technologies: [HER2 tyrosine kinase inhibitors](https://onco.cc/technologies/her2-tyrosine-kinase-inhibitors/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Pertuzumab](https://onco.cc/drugs/pertuzumab/), [Trastuzumab](https://onco.cc/drugs/trastuzumab/), [Tucatinib](https://onco.cc/drugs/tucatinib/)
- companies: [Pfizer (incl. Seagen)](https://onco.cc/companies/pfizer/)
- key papers: [HER2CLIMB-05: A Phase III Study of Tucatinib Versus Placebo in Combination With Trastuzumab and Pertuzumab as First-Line Maintenance Therapy for HER2+ Metastatic Breast Cancer](https://onco.cc/key-papers/paper-her2climb-05-j-clin-oncol-2026/)

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