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

NCT07552181 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IIT2024-04-YUAN-PREVAIL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

TNBC - Triple-Negative Breast Cancer; TNBC; Early Stage Triple-Negative Breast Carcinoma

Keywords

Pembrolizumab; Neoadjuvant Chemo-Immunotherapy; TNBC; High-risk early stage TNBC

Outcome Measures

Primary Outcomes (1)

• 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.

  Time of Surgery

Secondary Outcomes (7)

• Event Free Survival (EFS)

  Up to 5 years after surgery

• Invasive Disease-Free Survival (IDFS)

  Up to 5 years after treatment

• Overall Survival (OS)

  Up to 5 years after treatment

• Patient Quality of Life

  6 month

• Patient Quality of Life

  6 month

Study Arms (1)

Single Arm

EXPERIMENTAL

Live biotherapeutic product

Drug: Live biotherapeutic product: MO-03 1 capsule PO BID

Interventions

Live biotherapeutic product: MO-03 1 capsule PO BID DRUG

Live biotherapeutic product: MO-03 1 capsule PO BID + standard of care pembrolizumab and carbo-docetaxel or carbo-paclitaxel followed by Adriamycin cyclophosphamide

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ECOG 0-1
• Patients must have adequate organ function as defined in the following. Specimens must be collected within 28 days prior to the start of study treatment.
• For patients who will receive regimen 1 only: Participants must have adequate cardiac function. Participants must have left ventricular ejection fraction ≥ 50% as assessed by either ECHO or MUGA within 28 days prior to the start of treatment. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must be class 2B or better.
• Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 28 days of the start of treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Male participants: A male participant must agree to use a contraception as detailed in Appendix B of this protocol during the treatment period and for at least 120 days after the last dose of MO-03 and refrain from donating sperm during this period.
• Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix B), not breastfeeding, and at least one of the following conditions applies:
• i. Not a woman of childbearing potential (WOCBP) as defined in Appendix B OR ii. Females of child-bearing potential must be willing to use effective contraception during study and for 120 days after the last dose of MO-03.
• Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

You may not qualify if:

• 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.
• Note: No testing for Hepatitis B is required unless mandated by local health authority.
• 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.
• Participant must not have severe infection within 14 days prior to enrollment.
• Prohibited Treatments and/or Therapies:
• Any prior chemotherapy, biological therapy, immunotherapy for the current breast cancer diagnosis prior to start of study intervention
• Prior use of immune checkpoint inhibitor is prohibited
• Prior breast surgery or radiation therapy for current invasive breast cancer
• Participants must not have a diagnosis of immunodeficiency and be receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to enrollment.
• Participants must not have active autoimmune disease that has required systemic treatment in 2 years prior to enrollment (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroidreplacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
• Participants must not have a history of (non-infectious) pneumonitis that required steroids or has current (non-infectious) pneumonitis.
• Any live vaccine within 30 days prior to the first dose of study drug and for 3 months after chemo-immunotherapy. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
• Participants on any dose of warfarin. Use of low molecular weight heparin, antithrombin agents, anti-platelet agents or factor Xa inhibitors is allowed

Sponsors & Collaborators

• Yuan Yuan: lead
• Osel, Inc.: collaborator
• Miyarisan Pharmaceuticals, Co., Ltd.: collaborator

Study Sites (3)

Cedars-Sinai Medical Center Beverly Hills

Beverly Hills, California, 90211, United States

Location

CS Cancer at Valley Oncology Medical Group

Tarzana, California, 91356, United States

Location

Hunt Cancer Institute, an Affiliate of CS Cancer

Torrance, California, 90505, United States

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yuan Yuan, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Jin Sun Lee-Bitar, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Navigator

CONTACT

3104232133; GroupCancerTrialInformation@cshs.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2035
• Study Completion (Estimated): September 1, 2035
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (3)