TNBC - Triple-Negative Breast CancerPhase 2NCT07552181
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 testing Live biotherapeutic product: MO-03 1 capsule PO BID in people with TNBC - Triple-Negative Breast Cancer and TNBC, run by Yuan Yuan at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TNBC - Triple-Negative Breast Cancer, TNBC, Early Stage Triple-Negative Breast Carcinoma
- What is being tested?
- Live biotherapeutic product: MO-03 1 capsule PO BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2026to Sep 2035
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- 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.
Who cannot join
- 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.
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- 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
- Participants may not use any other live biotherapeutic products (LBP) or supplementary use of probiotics in pill form during their participation in the study (e.g., Ferring's Rebyota, Vowst)
- Participants may not be currently participating in or participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
- Known allergy to any of the components within the study agents and/or their excipients (i.e., corn starch, lactose, microcrystalline cellulose, croscarmellose sodium or magnesium stearate).
- Medical history and concurrent diseases:
- Any prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least five years
- Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (Note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention
- History of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- Known history of active TB (Mycobacterium tuberculosis)
- Intercurrent or historic medical condition that increases subject risk in the opinion of the Investigator. Eligibility may be revisited for intercurrent medical conditions once resolution/recovery is deemed adequate by the investigator (e.g., recovery from major surgery, completion of treatment for severe infection).
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Has had an allogenic tissue/solid organ transplant.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yuan Yuan, MD contact
United States3 sites
Cedars-Sinai Medical Center Beverly Hills
Beverly Hills, California, 90211
Clinical Trial Recruitment Navigator, 310-423-5842, GroupCancerTrialInformation@cshs.org
Yuan Yuan, MD
CS Cancer at Valley Oncology Medical Group
Tarzana, California, 91356
Ryan Ponec, MD
Natasha Banerjee, MD
Hunt Cancer Institute, an Affiliate of CS Cancer
Torrance, California, 90505
Sarah Valdez, 3107503300 ext. 73422, sarah.valdez@tmphysicians.com
David Chan, MD
About this study
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.
- Being tested
- Live biotherapeutic product: MO-03 1 capsule PO BID
- Keywords
- Pembrolizumab, Neoadjuvant Chemo-Immunotherapy, TNBC, High-risk early stage TNBC
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live biotherapeutic product: MO-03 1 capsule PO BIDDrug
Live biotherapeutic product: MO-03 1 capsule PO BID + standard of care pembrolizumab and carbo-docetaxel or carbo-paclitaxel followed by Adriamycin cyclophosphamide
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Live biotherapeutic product Receives: Drug: Live biotherapeutic product: MO-03 1 capsule PO BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time of Surgery
Secondary outcomes (7)
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.
Measured: Up to 5 years after surgery
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
Measured: Up to 5 years after treatment
Overall Survival (OS)
Overall survival is defined as the rate of patients who remain alive at the end of follow-up.
Measured: Up to 5 years after treatment
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.
Measured: 6 month
Patient Quality of Life
Change in patient's quality of life scores by PROMIS-29 (Patient-Reported Outcomes Measurement Information System) from baseline to the 6-month post-operative follow-up visit.
Measured: 6 month
Patient Quality of Life
Change in patient's quality of life scores by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30) from baseline to the 6-month post-operative follow-up visit.
Measured: 6 month
Safety and Toxicity of MO-03
Safety and toxicity will be assessed by the number of adverse events at least possibly related to MO-03 per NCI's CTCAE v5.0 from baseline until the post-operative/EOT visit.
Measured: From Baseline till end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2035 (estimated)
- Study completionSep 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBC - Triple-Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuan Yuan
- Sponsor type
- University, hospital or other
- Collaborators
- Osel, Inc., Miyarisan Pharmaceuticals, Co., Ltd.
- Responsible party
- Sponsor-investigator, Yuan Yuan, Cedars-Sinai Medical Center
- Investigators
- Yuan Yuan, MD, Principal investigator, Cedars-Sinai Medical CenterJin Sun Lee-Bitar, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552181
- Sponsor's protocol ID
- IIT2024-04-YUAN-PREVAIL
- Status last verified
- Aug 2026
- First submitted
- 13 Apr 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Pembrolizumab/Chemotherapy With Live Biotherapeutic Product MO-03 in Patients With Early Stage Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07552181
- Acronym / sponsor ID
- IIT2024-04-YUAN-PREVAIL
- Keywords
- Pembrolizumab, Neoadjuvant Chemo-Immunotherapy, TNBC, High-risk early stage TNBC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yuan YuanUniversity, hospital or other
- Collaborators
- Osel, Inc., Miyarisan Pharmaceuticals, Co., Ltd.
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2035 (estimated)
- Study completion
- Sep 2035 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Live biotherapeutic product: MO-03 1 capsule PO BIDLive biotherapeutic product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live biotherapeutic product: MO-03 1 capsule PO BIDLive biotherapeutic product: MO-03 1 capsule PO BID + standard of care pembrolizumab and carbo-docetaxel or carbo-paclitaxel followed by Adriamycin cyclophosphamide | Drug | Single Arm |
Primary outcome
Pathological Complete Response (pCR)
Time frame: Time of Surgery
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.
7 secondary outcomes
Event Free Survival (EFS)
Time frame: Up to 5 years after surgery
Invasive Disease-Free Survival (IDFS)
Time frame: Up to 5 years after treatment
Overall Survival (OS)
Time frame: Up to 5 years after treatment
Patient Quality of Life
Time frame: 6 month
Patient Quality of Life
Time frame: 6 month
Patient Quality of Life
Time frame: 6 month
Safety and Toxicity of MO-03
Time frame: From Baseline till end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuan Yuan, MD contact
Yuan Yuan, MD principal investigator
Cedars-Sinai Medical Center
Jin Sun Lee-Bitar, MD principal investigator
Cedars-Sinai Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Live biotherapeutic product: MO-03 1 capsule PO BID in people with TNBC - Triple-Negative Breast Cancer and TNBC, run by Yuan Yuan at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Navigator (310-423-5842, GroupCancerTrialInformation@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: Time of Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.