Pumitamig for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment, pumitamig, combined with chemotherapy to determine its effectiveness for certain types of breast cancer. Participants will be randomly assigned to receive either pumitamig plus chemotherapy or a placebo (a harmless pill resembling the real drug) plus chemotherapy. The trial targets individuals with advanced breast cancer that cannot be treated with a specific type of immunotherapy. Those whose breast cancer has spread or recurred and who have not succeeded with other treatments might qualify. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications. However, you cannot have received certain treatments like systemic anticancer therapy for advanced disease or high-dose corticosteroids recently. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that Pumitamig is likely to be safe for humans?
Research has shown that pumitamig, when combined with chemotherapy, is generally safe. In past studies, most patients handled the treatment well. Importantly, no new safety issues emerged, and few patients discontinued the treatment due to side effects. These results suggest that pumitamig is safe for people, although individual experiences may differ.12345
Why do researchers think this study treatment might be promising?
Pumitamig is unique because it combines with the treatment of physician's choice (TPC) chemotherapy to target breast cancer cells more precisely. Unlike standard treatments that rely solely on chemotherapy, Pumitamig introduces a new active ingredient, BNT327, which may enhance the effectiveness of the chemotherapy regimen. Researchers are excited about this treatment because it could offer improved outcomes by potentially increasing the cancer-killing power of existing chemotherapy options.
What evidence suggests that pumitamig might be an effective treatment for breast cancer?
Research has shown that Pumitamig, which participants in this trial may receive, may help treat breast cancer. In one study, when combined with chemotherapy, 78.6% of patients with advanced triple-negative breast cancer responded positively. Another report found a 76.3% positive response rate in a group of patients evaluated for effectiveness. Pumitamig is a treatment that enhances the immune system's ability to target cancer cells. These results suggest that Pumitamig could be effective for breast cancer patients, particularly those with more aggressive forms.34678
Who Is on the Research Team?
BioNTech Responsible Person
Principal Investigator
BioNTech SE
Are You a Good Fit for This Trial?
This trial is for adults with a specific type of advanced breast cancer called Triple-Negative or ER-low/HER2-negative. They must have at least one measurable tumor and cannot be eligible for certain immunotherapy plus chemo treatments based on their PD-L1 status. Participants need to provide a tissue sample and be in good physical condition (ECOG 0 or 1).Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pumitamig or placebo in combination with chemotherapy until disease progression, intolerable toxicity, withdrawal, death, or trial termination
Safety Follow-up
Participants are monitored for safety for up to 90 days after the last dose of trial treatment
Survival Follow-up
Participants are monitored for survival status until death, withdrawal of consent, loss of contact, or sponsor decision
What Are the Treatments Tested in This Trial?
Interventions
- Pumitamig
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioNTech SE
Lead Sponsor
Prof. Dr. Ugur Sahin
BioNTech SE
Chief Executive Officer since 2008
MD from University of Cologne
Prof. Özlem Türeci
BioNTech SE
Chief Medical Officer since 2018
MD from Saarland University
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania