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.
Female or male age ≥ 18 years of age.
Patients with high-risk early stage triple negative breast cancer. Triple negative status will be defined as ER≤10%, PR≤10%, HER2 negative (by FISH) per ASCO-CAP guidelines.
Clinically staging T1c any N M0 or any T N1-3 M0.
Willing to provide FFPE from baseline standard of care biopsy and post-treatment residual tumor at the time of surgery.
Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration.
Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated.
Participant must not have uncontrolled diabetes or hypertension in the opinion of treating investigator.
Participant must not have had a major surgery within 14 days prior to screening.
Yuan Yuan
Lead sponsor
Cedars-Sinai Medical Center
Sponsor institution
Osel, Inc.
Collaborator
Miyarisan Pharmaceuticals, Co., Ltd.
Collaborator