Could a Nab-Paclitaxel Combination Become the New Standard for HER2-Positive Breast Cancer?

Why Is Neoadjuvant Treatment Important?

In breast cancer, neoadjuvant treatment is a treatment approach given before surgery that aims to improve surgical outcomes by reducing tumor size. In HER2-positive early-stage breast cancer, combinations of targeted therapies and chemotherapy have increased pathological complete response (pCR) rates, with a major impact on long-term survival. However, the optimal drug combination remains a matter of debate.

In January 2025, THE LANCET Oncology published the HELEN-006 phase III study, which examined whether nab-paclitaxel combined with trastuzumab and pertuzumab was more effective than the standard docetaxel / carboplatin regimen.

Study Design and Patient Population

HELEN-006 is a multicenter, open-label phase III clinical trial based in China. Between September 2020 and March 2023, the study was conducted in 669 female patients.

• Age Range: The median age was reported as 50.

• Treatment Arms:

  • First group: Nab-paclitaxel (125 mg/m²) once weekly on days 1, 8, and 15, for a total of 6 cycles.

  • Second group: Docetaxel (75 mg/m²) and carboplatin (AUC=6), on day 1 of each cycle, for a total of 6 cycles.

Both groups received trastuzumab and pertuzumab, with a trastuzumab loading dose of 8 mg/kg and maintenance dose of 6 mg/kg, and a pertuzumab loading dose of 840 mg and maintenance dose of 420 mg.

Main Findings

• Median Follow-Up: 26 months.

• Pathological Complete Response Rate (pCR):

  • Nab-paclitaxel group: 66.3% (confidence interval [CI] 61.2% – 71.4%)

  • Docetaxel / carboplatin group: 57.6% (CI 52.3% – 62.9%)

  • Nab-paclitaxel increased the likelihood of a pathological complete response by 54% compared with docetaxel / carboplatin. Odds ratio: 1.54 (CI 1.10 – 2.14; P = 0.011)

These results showed that the nab-paclitaxel combination offered a clear advantage over the docetaxel / carboplatin regimen.

Adverse Event Profile

• Grade 3-4 Adverse Events:

  • 30% in the nab-paclitaxel group.

  • 38% in the docetaxel/carboplatin group.

• Common Adverse Events:

  • Nab-paclitaxel group: Neuropathy (13%), diarrhea (8%), nausea (7%).

  • Docetaxel/carboplatin group: Nausea (23%), diarrhea (16%), vomiting (8%).

• Serious drug-related adverse events: 3 patients (1%) in the nab-paclitaxel group and 5 patients (2%) in the docetaxel/carboplatin group.

• Treatment-Related Deaths: None were observed.

Conclusion and Assessment

The researchers suggested that the combination of nab-paclitaxel, trastuzumab, and pertuzumab offered a significant advantage over standard neoadjuvant treatment in HER2-positive early-stage breast cancer and could be considered a new standard of treatment.

This study shows promise for the nab-paclitaxel-based regimen, with a lower adverse event profile and a higher pCR rate. However, long-term survival data and confirmation of similar success rates in other patient populations are needed.

Future Research and Clinical Applications

These findings encourage evaluation of the nab-paclitaxel combination in broader patient populations. Continued research into individualized treatment strategies to select the optimal treatment in HER2-positive breast cancer may increase the potential to improve patient responses.