Patritumab Deruxtecan + Pembrolizumab for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
Researchers are looking for new ways to treat triple-negative breast cancer (TNBC) and hormone receptor (HR) low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. The main goals of this study are to learn:* About the safety of the study treatments and if people tolerate them* If people who receive patritumab deruxtecan, pembrolizumab, and chemotherapy before surgery have fewer cancer cells removed during surgery compared to those who receive only pembrolizumab (pembro) and chemotherapy.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What safety information is available for Pembrolizumab in cancer treatment?
Pembrolizumab, used in cancer treatment, has been associated with a 1.2% risk of fatal adverse events, which can vary by cancer type and when combined with chemotherapy. Common serious side effects include infections, heart problems, and lung inflammation, and it can also cause skin reactions and autoimmune issues affecting various organs.12345
How is the drug Patritumab Deruxtecan + Pembrolizumab different from other breast cancer treatments?
This treatment combines Patritumab Deruxtecan, an antibody-drug conjugate that targets cancer cells, with Pembrolizumab, an immune checkpoint inhibitor that helps the immune system attack cancer. This combination is unique because it uses both targeted therapy and immunotherapy to potentially enhance the treatment's effectiveness against breast cancer.16789
What data supports the effectiveness of the drug Patritumab Deruxtecan + Pembrolizumab for breast cancer?
Research shows that pembrolizumab, when combined with other treatments like trastuzumab, has shown clinical benefits in advanced breast cancer, particularly in cases resistant to previous treatments. This suggests that pembrolizumab can enhance the immune system's ability to fight cancer, which may support its use in combination with other drugs for breast cancer.810111213
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for people with early-stage, high-risk triple-negative or hormone receptor-low positive/HER-2 negative breast cancer that hasn't spread. Participants should be relatively healthy and active (ECOG 0-1), have a good heart function (LVEF ≥50%), and no history of certain infections or treatments like anti-PD-1/L1/L2 agents.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive neoadjuvant pembrolizumab and other agents for 12 weeks
Surgery
Participants undergo surgery for breast cancer 3 to 6 weeks after last dose of neoadjuvant treatment
Adjuvant Treatment
Participants receive adjuvant pembrolizumab and additional treatment of physician's choice for approximately 30 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Patritumab Deruxtecan
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Daiichi Sankyo
Industry Sponsor
Hiroyuki Okuzawa
Daiichi Sankyo
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University
Yuki Abe
Daiichi Sankyo
Chief Medical Officer since 2023
MD