Evaluate the Clinical Benefit of a Post-operative Treatment Associating Radiotherapy + Nivolumab + Ipilimumab Versus Radiotherapy + Capecitabine for Triple Negative Breast Cancer Patients With Residual Disease

Phase 2 Unknown 95 enrolled Centre Leon Berard

RandomizedParallel-groupOpen-labelTreatment

Summary

To evaluate the clinical benefit of a post-operative adjuvant therapy combining radiotherapy + Nivolumab + Ipilimumab versus radiotherapy + Capecitabine in Triple Negative Breast Cancer (TNBC) patients with residual disease after neoadjuvant chemotherapy.

Timeline

Start: 2019-07-02
Primary completion: 2024-03-15
Completion: 2024-05-01

Outcome

Missed primary endpoint

paper did not significantly improve DFS compared to capecitabine in TNBC patients with RCB II-III PMID 41314029 ↗

Publications

Tredan O, Loirat D, Chabaud S, Toussaint P, Petit T, Viret F, Levy C, Robert A, Grenier J, Mansi L, Spano JP, Patsouris A, Derbel O, Jouannaud C, Ferrero JM, Frenel JS, Molin Y, Doublet L, Heudel PE, Pierga JY, Garin G, Perol D, Bachelot T. Nivolumab in combination with ipilimumab versus capecitabine as post-operative treatment for triple negative breast cancer patients with residual disease after neoadjuvant chemotherapy: a multicentre, randomized, open-label phase II trial - BREASTIMMUNE-03. Breast. 2026 Feb;85:104648. doi: 10.1016/j.breast.2025.104648. Epub 2025 Nov 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Capecitabine	Small molecule	1000 mg/m2	—
Subject	Ipilimumab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Nivolumab	Monoclonal antibody	360 mg	Intravenous