Can Adding Pembrolizumab to Chemotherapy Improve Outcomes for Early Triple-Negative Breast Cancer?

Apr 9, 2025

What Did the Research Discover?

This study examined whether adding pembrolizumab (Keytruda), an immune checkpoint inhibitor, to standard chemotherapy before surgery could improve outcomes for patients with early-stage triple-negative breast cancer (TNBC).

In this large phase 3 trial, 1,174 patients with stage II or III TNBC were randomly assigned to receive either:

  • Pembrolizumab plus chemotherapy, or
  • A placebo plus chemotherapy

The main goal was to see how many patients had a pathological complete response (pCR)—meaning no remaining invasive cancer in the breast or lymph nodes—by the time of surgery.

The results showed that 64.8% of patients who received pembrolizumab with chemotherapy had a pCR, compared to 51.2% of those who received only chemotherapy. This means adding pembrolizumab increased the pCR rate by about 13.6 percentage points, a statistically significant improvement.

Additionally, after about 15.5 months of follow-up, patients who received pembrolizumab were less likely to experience disease progression, recurrence, or death compared to those in the placebo group (7.4% vs. 11.8%).

How Can I Apply This Information?

This study suggests that adding pembrolizumab to chemotherapy may significantly improve treatment response in early-stage TNBC. For patients diagnosed with this aggressive form of breast cancer, this combination therapy could:

  • Increase the chance of eliminating cancer before surgery
  • Potentially improve long-term survival

However, side effects were slightly more common in the pembrolizumab group. The most frequent severe side effects included low blood cell counts (neutropenia, anemia), fever, and infusion-related reactions. While these are expected with chemotherapy, patients should discuss potential risks and benefits with their doctors to determine if this approach is suitable for them.

If you or a loved one has been diagnosed with early-stage triple-negative breast cancer, this research highlights an important new treatment option that may improve outcomes.

Source

Schmid P, Cortes J, Pusztai L, McArthur H, Kümmel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M. Pembrolizumab for early triple-negative breast cancer. New England Journal of Medicine. 2020 Feb 27;382(9):810-21. https://www.nejm.org/doi/10.1056/NEJMoa1910549?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed 

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