Timing of nivolumab with neoadjuvant carboplatin and paclitaxel for early triple-negative breast cancer (BCT1902/IBCSG 61-20; Neo-N): a non-comparative, open-label, randomised, phase 2 trial

Clinical Trial Overview

The study published in Lancet Oncology explores the best timing for using nivolumab (a type of PD-1 inhibitor) alongside chemotherapy in patients with early triple-negative breast cancer. The goal was to see how two different schedules of administering nivolumab with carboplatin and paclitaxel (two chemotherapy drugs) would affect treatment outcomes.

Study Details

This research was a phase 2 trial conducted in 12 hospitals across Australia, New Zealand, and Italy. It included women aged 18 and older who had specific types of breast cancer that were untreated and operable. Participants were randomly assigned to one of two groups:

  • Lead-in Group: Received nivolumab first, followed by chemotherapy.
  • Concurrent Group: Received nivolumab and chemotherapy together.

Key Findings

The trial enrolled 124 participants, but 14 were found ineligible, leaving 110 for the study. Of those, 108 were analyzed for results. The study observed the following:

  • Pathological complete response (cancer completely gone at surgery) was seen in 51% of the lead-in group and 55% of the concurrent group.
  • Many patients experienced side effects, with 65% reporting serious treatment-related events, such as decreased white blood cells and anemia.
  • No treatment-related deaths were reported.

Conclusions

The study did not find a significant advantage for starting nivolumab before chemotherapy. However, both groups achieved high rates of cancer response, suggesting that shorter chemotherapy regimens without anthracyclines could be effective for these patients. More research is needed to compare these results with existing standard treatments.

Practical Solutions for Healthcare

Based on this trial, healthcare providers should focus on:

  • Setting clear goals for treatment outcomes.
  • Choosing appropriate AI tools to analyze patient data and improve treatment plans.
  • Starting with pilot projects to implement new findings and track their effectiveness in real-world settings.

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