Triple-negative breast cancer (TNBC): guideline history

Anchored to: FDA accelerated approval of sacituzumab govitecan (April 2020) and approval of pembrolizumab with chemotherapy for PD-L1 CPS 10 or above (November 2020, KEYNOTE-355)

• addedMetastatic, later lines: Sacituzumab govitecan after at least two prior therapies.
• addedMetastatic, first line, PD-L1 CPS 10 or above: Pembrolizumab with chemotherapy as a preferred first-line regimen.

Anchored to: FDA approval of neoadjuvant and adjuvant pembrolizumab (July 2021, KEYNOTE-522); withdrawal of the atezolizumab TNBC indication (August 2021, IMpassion131)

• addedStage II-III, neoadjuvant: Pembrolizumab with carboplatin-paclitaxel then anthracycline-cyclophosphamide, continued after surgery, as the preferred regimen for stage II-III disease.
• removedMetastatic, first line, PD-L1-positive: Atezolizumab with nab-paclitaxel removed after the sponsor withdrew the US indication when IMpassion131 failed to confirm IMpassion130.

Anchored to: FDA approvals of adjuvant olaparib for germline BRCA carriers (March 2022, OlympiA) and trastuzumab deruxtecan for HER2-low disease (August 2022, DESTINY-Breast04)

• addedAdjuvant, germline BRCA, high risk: Olaparib for one year after chemotherapy in germline BRCA-mutated high-risk HER2-negative disease.
• addedMetastatic, HER2-low, after chemotherapy: Trastuzumab deruxtecan for HER2-low (IHC 1+ or 2+/ISH-negative) disease after one prior chemotherapy, including triple-negative disease that is HER2-low.

Anchored to: Annals of Oncology publication, 2024

• addedStage II-III, neoadjuvant: Neoadjuvant pembrolizumab with chemotherapy, continued after surgery, recommended for stage II-III TNBC [I, A; ESMO-MCBS A].
• addedAdjuvant, germline BRCA: One year of adjuvant olaparib for germline BRCA carriers with high-risk disease [I, A].