TRAIN-2
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.
Overview
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.
- 67 vs 68 out of 100 had no cancer left at surgery with Carboplatin-paclitaxel + trastuzumab + pertuzumab compared with FEC then carboplatin-paclitaxel + trastuzumab + pertuzumab; 1 fewer per 100.
- On this measure the first group did worse, not better.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Stage II to III HER2-positive breast cancer: neoadjuvant carboplatin and paclitaxel with trastuzumab and pertuzumab, with or without three cycles of anthracycline first. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (HER2); the result should not be assumed for people whose cancer does not have it.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
438 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Pathological complete response (breast and axilla)primary | Carboplatin-paclitaxel + trastuzumab + pertuzumab | 219 | 67% | - | - | link |
| FEC then carboplatin-paclitaxel + trastuzumab + pertuzumab | 219 | 68% |
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