Trial results for pembrolizumab (Keytruda) in treating patients with hormone receptor positive, localized inflammatory breast cancer (IBC) were posted on ClinicalTrials.gov on 2026-01-22. The study reported a median Disease Free Survival (DFS) of 4.22 years in patients who did not achieve a pathological complete response to chemotherapy and were receiving hormone therapy.
Background
Pembrolizumab is an immunotherapy with monoclonal antibodies. It is designed to help the body's immune system attack cancer cells and may interfere with the ability of tumor cells to grow and spread. This trial specifically investigated its use in patients with hormone receptor positive, localized inflammatory breast cancer who were receiving hormone therapy and had not achieved a pathological complete response to prior chemotherapy.
Trial design
The Phase 2 trial (NCT02971748) investigated pembrolizumab in patients with hormone receptor positive, localized inflammatory breast cancer. The study enrolled 36 participants with conditions including Anatomic Stage IIIB and IIIC Breast Cancer AJCC v8, Breast Inflammatory Carcinoma, and Prognostic Stage IIIB and IIIC Breast Cancer AJCC v8. Participants were receiving hormone therapy and had not achieved a pathological complete response to chemotherapy.
Key results
The trial results included data on Disease Free Survival (DFS) and treatment-related adverse events.
- For the outcome of "Disease Free Survival (DFS)" in the group receiving pembrolizumab and hormonal therapy, the median DFS was 4.22 years. The data also reported a 95% Confidence Interval, though the specific values were not provided.
- Regarding "Participants With Treatment-Related Adverse Events" in the same treatment group, the highest reported count for a single adverse event was 7 participants. Other reported counts for specific adverse events included 4 participants, 3 participants, and 2 participants, along with several events affecting 1 participant each.
What this means
The reported median Disease Free Survival (DFS) of 4.22 years offers an initial indication of the potential efficacy of pembrolizumab when added to hormone therapy in this specific patient population. These patients have hormone receptor positive, localized inflammatory breast cancer and did not achieve a pathological complete response to prior chemotherapy, representing a challenging clinical scenario. The safety data, while not fully detailed, indicates that treatment-related adverse events were observed, with the highest count for any single event being 7 participants. Further context and detailed analysis would be required to fully understand the clinical significance of these findings, particularly in comparison to standard care or other treatment options.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02971748, titled "Pembrolizumab in Treating Patients With Hormone Receptor Positive, Localized Inflammatory Breast Cancer Who Are Receiving Hormone Therapy and Did Not Achieve a Pathological Complete Response to Chemotherapy," were posted on 2026-01-22 on clinicaltrials.gov.