# HER2CLIMB

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

## TL;DR

The first trial to prove a drug helps HER2-positive brain metastases, extending survival by four and a half months overall.

## Summary

HER2CLIMB, trial NCT02614794 sponsored by Seagen, now Pfizer, and reported in 2019, was the first trial to prove that a drug helps HER2-positive brain metastases, extending survival overall and in patients with brain disease. It randomised 612 women with HER2-positive metastatic breast cancer after trastuzumab, pertuzumab and trastuzumab emtansine, including 48 percent with active brain metastases, to tucatinib or placebo with trastuzumab and capecitabine, met its primary progression-free survival endpoint, improved overall survival and sharply reduced central nervous system progression, leading to approval in April 2020. OnCo links it to HER2 as a target, tucatinib, trastuzumab, the HER2-positive brain metastases term, Nancy U. Lin and the brain as a bottleneck. Whether systemic therapy should now come before local brain treatment is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT02614794
- Phase: 2
- Setting: HER2+ metastatic breast cancer after trastuzumab, pertuzumab, and T-DM1, including active brain metastases: tucatinib + trastuzumab + capecitabine vs placebo + trastuzumab + capecitabine
- Sponsor: Seagen (Pfizer)
- Enrolled: 612
- Result: OS 21.9 vs 17.4 months, HR 0.66; CNS-PFS HR 0.32.
- Outcomes: Progression-free survival: Tucatinib arm 7.8 months vs Placebo arm 5.6 months, HR 0.54; Overall survival: Tucatinib arm 21.9 months vs Placebo arm 17.4 months, HR 0.66
- Replication: Tucatinib's CNS activity replicated in HER2CLIMB-02 (with T-DM1) and its efficacy in HER2CLIMB-05 (first-line maintenance).

## Sources

- ClinicalTrials.gov NCT02614794: https://clinicaltrials.gov/study/NCT02614794

## Connected records

- cancers: [Brain metastases (secondary brain tumours)](https://onco.cc/cancers/secondary-brain-tumours/), [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/)
- targets: [HER2](https://onco.cc/targets/her2/)
- drugs: [Trastuzumab](https://onco.cc/drugs/trastuzumab/), [Tucatinib](https://onco.cc/drugs/tucatinib/)
- companies: [Pfizer (incl. Seagen)](https://onco.cc/companies/pfizer/)
- terms: [HER2-positive brain metastases](https://onco.cc/terms/her2-brain-metastases/)
- people: [Nancy U. Lin](https://onco.cc/people/nancy-lin/)
- key papers: [HER2CLIMB brain metastases analysis: intracranial efficacy and survival with tucatinib](https://onco.cc/key-papers/paper-her2climb-brain-lin-jco-2020/), [HER2CLIMB: tucatinib with trastuzumab and capecitabine for HER2-positive metastatic breast cancer, including brain metastases](https://onco.cc/key-papers/paper-her2climb-nejm-2020/)
- pairings: [Tucatinib + trastuzumab + capecitabine for brain metastases](https://onco.cc/pairings/tucatinib-triplet-brain-mets/)
- ideas: [Prevention trials aimed only at brain metastasis](https://onco.cc/ideas/idea-bio2-brain-met-prevention-trials/), [Stop excluding brain metastases from cancer trials](https://onco.cc/ideas/idea-bio2-cns-cohort-mandate/), [Systemic-first management of HER2-positive brain metastases](https://onco.cc/ideas/idea-cns-first-adc-strategy/)
- bottlenecks: [The brain: barrier and sanctuary](https://onco.cc/bottlenecks/b-brain-delivery/)

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