Phase II Trial of Pembrolizumab/Chemotherapy With Live Biotherapeutic Product MO-03 in Patients With Early Stage Triple Negative Breast Cancer

This is a single-arm and single site phase II trial combination of chemotherapy and pembrolizumab with LBP MO-03 in 50 trial participants with early triple negative breast cancer. MO-03 will be given at a dose of 4 x 10e9 CFU per capsule, 1 capsule taken orally twice daily. Patients will receive standard of care pembrolizumab 200 mg every 3 weeks in concurrent with a regimen of chemotherapy. Please refer to Table 2 for a summary of the chemo-immunotherapy with pembrolizumab containing regimens. Patients will continue to take MO-03 up until the day prior to surgery (lumpectomy or mastectomy). Post-surgery, patients will come in for a 2-week follow-up and then enter survival follow-up annually for 5 years.

NCT Number	NCT07552181
Lead Sponsor	Yuan Yuan Collaborators: Osel, Inc., Miyarisan Pharmaceuticals, Co., Ltd.
Conditions	TNBC - Triple-Negative Breast Cancer, TNBC, Early Stage Triple-Negative Breast Carcinoma
Enrollment	50 participants
Start Date	2026-09
Primary Completion	2035-09 (estimated)
Study Completion	2035-09 (estimated)
Updated on ClinicalTrials.gov	2026-08-05