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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Yuan Yuan
Study ID
NCT07552181
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Sep 30, 2026
Status verified
May 2026
Primary completion
Sep 30, 2035
Completion
Sep 30, 2035

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Live biotherapeutic product

Primary Outcome Measure

Pathological Complete Response (pCR) [ Time Frame: Time of Surgery ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical Center Beverly HillsBeverly HillsCalifornia90211
Clinical Trial Recruitment Navigator
[email protected]
3104232133
Yuan Yuan, MD (PRINCIPAL_INVESTIGATOR)
Philomena McAndrew, MD (SUB_INVESTIGATOR)
Karissa Britten, MD (SUB_INVESTIGATOR)
Maryliza El-Masry, MD (SUB_INVESTIGATOR)
CS Cancer at Valley Oncology Medical GroupTarzanaCalifornia91356
Ryan Ponec, MD (SUB_INVESTIGATOR)
Natasha Banerjee, MD (SUB_INVESTIGATOR)
Mazen Jizzini, MD (SUB_INVESTIGATOR)
Hunt Cancer Institute, an Affiliate of CS CancerTorranceCalifornia90505
Sarah Valdez
[email protected]
3107503300
David Chan, MD (SUB_INVESTIGATOR)
Vanessa Dickey, MD (SUB_INVESTIGATOR)
Hugo Hool, MD (SUB_INVESTIGATOR)
Swati Skiaria, MD (SUB_INVESTIGATOR)
Syed Jilani, MD (SUB_INVESTIGATOR)
Andrew Horodner, MD (SUB_INVESTIGATOR)
Thomas Lowe, MD (SUB_INVESTIGATOR)
Justin Tiulim, MD (SUB_INVESTIGATOR)

Find similar trials in Beverly Hills, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Cedars-Sinai Medical Center Beverly Hills· Beverly Hills, CACS Cancer at Valley Oncology Medical Group· Tarzana, CAHunt Cancer Institute, an Affiliate of CS Cancer· Torrance, CA

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