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.
Single group
Live biotherapeutic product: MO-03 1 capsule PO BID
DrugLive biotherapeutic product: MO-03 1 capsule PO BID + standard of care pembrolizumab and carbo-docetaxel or carbo-paclitaxel followed by Adriamycin cyclophosphamide
Pathological Complete Response (pCR)
Pathological complete response (pCR) will be defined as the absence of invasive residual disease in the breast and lymph nodes. This will be assessed at the time of surgery. Pathological complete response will be evaluated using residual cancer burden (RCB) classifier defined by ASCO/CAP guidelines.
Event Free Survival (EFS)
Event free survival is measured from the time of surgery to the first occurrence of any of the following events: disease progression or recurrence (local, regional, or distant), or death from any cause. During 5 year follow up.
Invasive Disease-Free Survival (IDFS)
Invasive disease-free survival is measured from the time of surgery until recurrence of invasive breast cancer (local, regional, or distant), death from any cause, or up to 5 years after treatment, whichever occurs first
Overall Survival (OS)
Overall survival is defined as the rate of patients who remain alive at the end of follow-up.
Patient Quality of Life
Change in patient's quality of life scores by PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue from baseline to the 6-month post-operative follow-up visit.
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Yuan Yuan
Lead sponsor
Cedars-Sinai Medical Center
Sponsor institution
Osel, Inc.
Collaborator
Miyarisan Pharmaceuticals, Co., Ltd.
Collaborator
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