A Comparison of Nab-PHP and TCbHP Efficacy in Neoadjuvant Therapy for HER2-positive Early Breast Cancer

Summary

The aim of this study is to evaluates the efficacy of weekly nab-paclitaxel monotherapy compared to the standard regimen of docetaxel plus carboplatin, both supplemented with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.

Timeline

Start

2020-09-18

Primary completion

2024-12-31

Completion

2024-12-31

Outcome

Met primary endpoint

paper 220 (66·3% [95% CI 61·2-71·4]) patients in the nab-paclitaxel group had a pathological complete response, compared with 194 (57·6% [52·3-62·9]) in the docetaxel plus carboplatin group PMID 39612919 ↗

paper combined odds ratio 1·54 [95% CI 1·10-2·14]; stratified p=0·011 PMID 39612919 ↗

Publications

• Chen XC, Jiao DC, Qiao JH, Wang CZ, Sun XF, Lu ZD, Li LF, Zhang CJ, Yan M, Wei Y, Chen B, Feng YQ, Deng M, Ma MD, Plichta JK, He YW, Liu ZZ. De-escalated neoadjuvant weekly nab-paclitaxel with trastuzumab and pertuzumab versus docetaxel, carboplatin, trastuzumab, and pertuzumab in patients with HER2-positive early breast cancer (HELEN-006): a multicentre, randomised, phase 3 trial. Lancet Oncol. 2025 Jan;26(1):27-36. doi: 10.1016/S1470-2045(24)00581-3. Epub 2024 Nov 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Carboplatin	Small molecule	6 unknown	Intravenous
Comparator	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	Nab-paclitaxel	Small molecule	125 mg/m2	Intravenous
Subject	Pertuzumab	Monoclonal antibody	420 mg	Intravenous
Subject	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous

Indications