Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of breast cancer

Leisha A. Emens, Sylvia Adams, Ashley Cimino-Mathews, Mary L. Disis, Margaret E. Gatti-Mays, Alice Y. Ho, Kevin Kalinsky, Heather L. McArthur, Elizabeth A. Mittendorf, Rita Nanda, David B. Page, Hope S. Rugo, Krista M. Rubin, Hatem Soliman, Patricia A. Spears, Sara M. Tolaney, Jennifer K. Litton

Research output: Contribution to journalArticlepeer-review


Breast cancer has historically been a disease for which immunotherapy was largely unavailable. Recently, the use of immune checkpoint inhibitors (ICIs) in combination with chemotherapy for the treatment of advanced/metastatic triple-negative breast cancer (TNBC) has demonstrated efficacy, including longer progression-free survival and increased overall survival in subsets of patients. Based on clinical benefit in randomized trials, ICIs in combination with chemotherapy for the treatment of some patients with advanced/metastatic TNBC have been approved by the United States (US) Food and Drug Administration (FDA), expanding options for patients. Ongoing questions remain, however, about the optimal chemotherapy backbone for immunotherapy, appropriate biomarker-based selection of patients for treatment, the optimal strategy for immunotherapy treatment in earlier stage disease, and potential use in histological subtypes other than TNBC. To provide guidance to the oncology community on these and other important concerns, the Society for Immunotherapy of Cancer (SITC) convened a multidisciplinary panel of experts to develop a clinical practice guideline (CPG). The expert panel drew upon the published literature as well as their clinical experience to develop recommendations for healthcare professionals on these important aspects of immunotherapeutic treatment for breast cancer, including diagnostic testing, treatment planning, immune-related adverse events (irAEs), and patient quality of life (QOL) considerations. The evidence-based and consensus-based recommendations in this CPG are intended to give guidance to cancer care providers treating patients with breast cancer.

Original languageEnglish (US)
Article numbere002597
JournalJournal for immunotherapy of cancer
Issue number8
StatePublished - Aug 13 2021


  • breast neoplasms
  • clinical trials as topic
  • guidelines as topic
  • immunotherapy

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Molecular Medicine
  • Oncology
  • Pharmacology
  • Cancer Research


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