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Clinical trialNCT07552181Not, yet, recruitingPhase 2Interventional

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

SponsorYuan YuanEnrollment50Early Stage Triple-Negative Breast CarcinomaTNBCTNBC - Triple-Negative Breast Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

3 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Cedars-Sinai Medical Center Beverly Hills

    Beverly Hills, California, United States

    Karissa Britten, MDMaryliza El-Masry, MDPhilomena McAndrew, MDYuan Yuan, MD
  • Cs Cancer at Valley Oncology Medical Group

    Tarzana, California, United States

    Mazen Jizzini, MDNatasha Banerjee, MDRyan Ponec, MD
  • Hunt Cancer Institute, An Affiliate of Cs Cancer

    Torrance, California, United States

    Andrew Horodner, MDDavid Chan, MDHugo Hool, MDJustin Tiulim, MDSwati Skiaria, MDSyed Jilani, MDThomas Lowe, MDVanessa Dickey, MD

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Live biotherapeutic product: MO-03 1 capsule PO BID
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Sept 2026
Primary completion
30 Sept 2035
Completion
30 Sept 2035
Last update posted
5 Aug 2026
Registered enrollment
50
Registry id
NCT07552181
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.