# TRAIN-2

Source: https://onco.cc/trials/train-2/  
OnCo record `train-2` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

TRAIN-2 showed that HER2-positive breast cancer can be treated before surgery without an anthracycline: carboplatin and paclitaxel with the two HER2 antibodies made the tumour disappear as often as an anthracycline regimen did, with less harm to the heart.

## Summary

TRAIN-2, trial NCT01996267 run by the Dutch Breast Cancer Research Group and published in the Lancet Oncology in 2018, randomised 438 patients with stage II or III HER2-positive breast cancer to nine cycles of carboplatin and paclitaxel with trastuzumab and pertuzumab, or to three cycles of fluorouracil, epirubicin and cyclophosphamide with the antibodies followed by six cycles of the same carboplatin-paclitaxel regimen. Pathological complete response in breast and axilla was 67 percent without the anthracycline and 68 percent with it, and the anthracycline arm had more febrile neutropenia and falls in left ventricular ejection fraction. Three-year event-free survival was 93.5 percent without and 92.7 percent with the anthracycline in the 2021 follow-up, and anthracycline-free dual-blockade regimens became the usual neoadjuvant approach in Europe. Whether a shorter or de-escalated regimen matches nine cycles is the question that followed.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Registry id: NCT01996267
- Phase: 3
- Setting: Stage II to III HER2-positive breast cancer: neoadjuvant carboplatin and paclitaxel with trastuzumab and pertuzumab, with or without three cycles of anthracycline first
- Sponsor: Dutch Breast Cancer Research Group (BOOG)
- Enrolled: 438
- Result: Pathological complete response 67% without anthracycline vs 68% with; 3-year event-free survival 93.5% vs 92.7%.
- Outcomes: Pathological complete response (breast and axilla): Carboplatin-paclitaxel + trastuzumab + pertuzumab 67% vs FEC then carboplatin-paclitaxel + trastuzumab + pertuzumab 68%
- Replication: Consistent with TRYPHAENA, in which anthracycline-free TCHP gave similar pathological complete response rates.

## Sources

- ClinicalTrials.gov NCT01996267: https://clinicaltrials.gov/study/NCT01996267
- van Ramshorst et al., TRAIN-2 (Lancet Oncology 2018): https://doi.org/10.1016/S1470-2045(18)30570-9

## Connected records

- cancers: [Early HER2-positive breast cancer](https://onco.cc/cancers/her2-positive-early-breast-cancer/), [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/)
- targets: [HER2](https://onco.cc/targets/her2/)
- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/), [Cyclophosphamide](https://onco.cc/drugs/cyclophosphamide/), [Epirubicin](https://onco.cc/drugs/epirubicin/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/), [Pertuzumab](https://onco.cc/drugs/pertuzumab/), [Trastuzumab](https://onco.cc/drugs/trastuzumab/)
- terms: [Dual HER2 blockade](https://onco.cc/terms/dual-her2-blockade/), [Pathologic complete response (pCR)](https://onco.cc/terms/pcr/)

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