Immunotherapy treatment trial for patients with triple-negative breast cancer

Study ID: S1418

A randomized, phase 3 trial to evaluate the efficacy and safety of MK-3475 (pembrolizumab) as adjuvant therapy for triple receptor-negative breast cancer with ≥ 1 cm residual invasive cancer or positive lymph nodes (ypN+) after neoadjuvant chemotherapy

This is a treatment trial for certain patients who have been diagnosed with triple receptor-negative breast cancer. Participants will be randomized, with some patients being treated with the immunotherapy drug pembrolizumab (popularly known as Keytruda®) intravenously.

Inclusion criteria:

  • Histologically confirmed triple-negative w/residual invasive breast cancer; no metastatic disease (i.e., must be M0)
  • Preferred axillary lymph node sampling performed after completion of neoadjuvant chemo
  • Documented pathologic involvement of the axillary nodes, minimum of five available unstained slides from the residual (post-neoadjuvant) invasive tumor in primary site or lymph node
  • Must have had neoadjuvant chemotherapy followed by surgery
  • Patients may receive post-operative (adjuvant) chemotherapy for up to 24 weeks of duration (e.g., 8 cycles of capecitabine as in the CREATE-X trial) after completion of surgery at the discretion of the treating physician
  • Must have resolution of adverse event(s)
  • Must have completed their final breast surgery (rendering them free from disease)
  • No prior immunotherapy with anti-PD-L1, anti-PD-1, anti-CTLA4 or similar drugs
  • No plans for concomitantly biologic therapy, hormonal therapy, other chemotherapy, surgery or other anti-cancer therapy except radiation therapy while receiving treatment on this protocol

Inclusion Snapshot

  • Must have been diagnosed with triple-negative breast cancer with residual invasive breast cancer and no metastatic disease
  • Must have had neoadjuvant chemotherapy followed by surgery
  • Must not have been previously treated with immunotherapy

Contact Information

Lankenau Institute for Medical Research trial