Pembrolizumab + Chemotherapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of treatments for individuals with early-stage triple-negative breast cancer. It includes chemotherapy, pembrolizumab (an immune therapy), and a live biotherapeutic product called MO-03. Researchers aim to determine if this combination can improve outcomes before surgery. Individuals diagnosed with high-risk early-stage triple-negative breast cancer who have not previously received treatment for this condition may be suitable candidates. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant advancements in cancer care.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot use certain treatments like live vaccines, warfarin, or other live biotherapeutic products during the study. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research on the safety of MO-03, a live biotherapeutic product used with pembrolizumab and chemotherapy for breast cancer, lacks clear data at this time. However, its presence in a Phase 2 trial indicates that earlier studies have already assessed its initial safety. This phase evaluates the treatment's effectiveness while continuing to monitor safety.
Pembrolizumab, a component of this treatment, has FDA approval for other uses, confirming its well-established safety profile. It is generally well-tolerated, though some individuals may experience fatigue or nausea.
Participants should consult their healthcare provider about potential risks and benefits before joining the trial.12345Why do researchers think this study treatment might be promising for breast cancer?
Pembrolizumab combined with chemotherapy is unique because it leverages the immune system to fight breast cancer. Unlike traditional chemotherapy, which directly targets cancer cells, pembrolizumab is an immunotherapy that helps the immune system recognize and destroy cancer cells more effectively. Researchers are excited because this approach could enhance the overall effectiveness of treatment by potentially reducing tumor size more significantly and improving survival rates, offering a promising new avenue for patients with breast cancer.
What evidence suggests that this treatment might be an effective treatment for breast cancer?
Research has shown that pembrolizumab, when combined with chemotherapy, yields promising results for treating triple-negative breast cancer. Studies have found that it can help the immune system fight cancer cells, leading to better patient outcomes. Although specific information on MO-03 is limited, using pembrolizumab with chemotherapy has proven effective in similar cases. This trial will further investigate these benefits by adding MO-03 to the treatment plan, aiming to strengthen the body's natural defenses and improve survival rates.46789
Who Is on the Research Team?
Yuan Yuan, MD
Principal Investigator
Cedars-Sinai Medical Center
Jin Sun Lee-Bitar, MD
Principal Investigator
Cedars-Sinai Medical Center
Are You a Good Fit for This Trial?
This trial is for adults (18+) with high-risk, early-stage triple negative breast cancer who have good organ and heart function. Both men and women can join if they use effective birth control during treatment. Participants must be healthy enough to undergo surgery and provide tissue samples.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab and chemotherapy with LBP MO-03 until the day prior to surgery
Post-surgery Follow-up
Participants undergo a 2-week follow-up after surgery
Long-term Follow-up
Participants enter survival follow-up annually for 5 years
What Are the Treatments Tested in This Trial?
Interventions
- MO-03
Trial Overview
The study tests a combination of standard chemotherapy, pembrolizumab (an immunotherapy), and an oral live biotherapeutic product called MO-03 in people with early triple negative breast cancer. All participants receive the same treatments before surgery.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Live biotherapeutic product
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yuan Yuan
Lead Sponsor
Osel, Inc.
Industry Sponsor
Miyarisan Pharmaceuticals, Co., Ltd.
Collaborator
Citations
Sacituzumab Govitecan in Untreated, Advanced Triple- ...
Sacituzumab govitecan led to significantly longer progression-free survival than chemotherapy among patients with advanced triple-negative ...
Real-world use and survival outcomes of sacituzumab ...
While patients with metastatic, pretreated HR + /HER2− breast cancer generally have better five-year survival rates than those with TNBC, ...
Real-World Clinical Outcomes With Sacituzumab Govitecan in ...
Our multi-institutional study demonstrates that sacituzumab govitecan is effective in heavily pretreated patients with metastatic triple-negative breast cancer.
ASCENT-03 Data Show Consistent Safety With ...
Sacituzumab govitecan showed manageable safety vs chemotherapy in first-line TNBC, with fewer dose changes and faster AE resolution.
5.
cancernetwork.com
cancernetwork.com/view/phase-iii-ascent-study-metastatic-tnbc-halted-due-compelling-efficacyPhase III ASCENT Study of Metastatic TNBC Halted Due to ...
Further, the clinical benefit rate was found to be 45.4%. Median progression-free survival was 5.5. months (95% CI, 4.1-6.3), and overall survival was 13.0 ...
HER2+ mBC: Safety Outcomes From the DESTINY ...
Insight on the safety events observed in the DESTINY-Breast03 trial and how this translates to real-world adverse event management in HER2+ ...
Antitumor Activity and Safety of Trastuzumab Deruxtecan in ...
Most patients (53/54; 98.1%) experienced ≥ 1 treatment-emergent adverse event (TEAE; grade ≥ 3; 34/54; 63.0%). Common (≥ 5%) grade ≥ 3 TEAEs ...
Trastuzumab deruxtecan (T-DXd) vs ...
We report updated survival results, including efficacy and safety, after median duration of follow-up of 41 mo. Methods: Pts were randomized 1:1 ...
Study Details | NCT03529110 | DS-8201a Versus T-DM1 ...
This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or ...
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