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NCT07552181 · ClinicalTrials.gov registry record · Phase 2
Phase II Trial of Pembrolizumab/Chemotherapy With Live Biotherapeutic Product MO-03 in Patients With Early Stage Triple Negative Breast Cancer
A Phase 2 study, sponsored by Yuan Yuan.
- Not yet
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT07552181: Clinical Trial Phase 2 study, sponsored by Yuan Yuan.
NCT07552181 is a Phase 2 study that has not yet begun recruiting, run by Yuan Yuan. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07552181, a Phase 2 study, has not yet begun recruiting, sponsored by Yuan Yuan.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Live biotherapeutic product: MO-03 1 capsule PO BID
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2026-09 |
| Est. Completion | 2035-09 |
| Phase | Phase 2 |
What is known before NCT07552181 opens enrollment
NCT07552181 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Live biotherapeutic product: MO-03 1 capsule PO BID is the first listed.
NCT07552181 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07552181 about?
NCT07552181 is a clinical study titled "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 sta...
What is the current status of trial NCT07552181?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2026-09. Estimated completion is 2035-09.
What interventions are being tested in trial NCT07552181?
The interventions under investigation include: Live biotherapeutic product: MO-03 1 capsule PO BID (DRUG).
Who is sponsoring clinical trial NCT07552181?
This trial is sponsored by Yuan Yuan, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07552181's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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