Pembrolizumab + T-DM1 for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a combination of two drugs, pembrolizumab (an immunotherapy drug) and T-DM1 (also known as trastuzumab-DM1, an antibody-drug conjugate), to determine their effectiveness in treating metastatic breast cancer, which has spread beyond the breast. The goal is to assess whether these drugs, when combined, can improve outcomes for patients with HER2-positive breast cancer, a type that tests positive for a protein promoting cancer cell growth. Ideal participants have confirmed stage IV HER2-positive breast cancer and have previously received treatments like trastuzumab and a taxane. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new combination therapy.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop any biologic or investigational therapy at least 21 days before joining. If you're on bisphosphonates, you can continue taking them during the study. Avoid using potent CYP3A4 inhibitors like ketoconazole and erythromycin while on T-DM1.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using pembrolizumab with trastuzumab emtansine (T-DM1) is generally safe and well-tolerated. In earlier studies, patients with advanced breast cancer who hadn't received T-DM1 before were treated with this combination. These studies found the treatment safe, with no major safety issues reported, and it was manageable for the patients.
The studies continue to explore the best dose and any possible side effects, but the combination appears promising in terms of safety. Participants in these studies help researchers understand how these drugs work together, and their involvement is crucial for improving breast cancer treatment.12345Why are researchers excited about this trial's treatments?
Pembrolizumab combined with Trastuzumab-DM1 is unique because it leverages a dual approach to treat breast cancer. While standard treatments typically focus on either immune system activation or targeted therapy, this combination uses pembrolizumab to enhance the immune system's ability to detect and destroy cancer cells. At the same time, Trastuzumab-DM1 delivers targeted chemotherapy directly to the cancer cells, minimizing damage to healthy tissues. Researchers are excited about this treatment because it offers the potential for increased effectiveness by combining these two powerful mechanisms, potentially leading to better outcomes for patients.
What evidence suggests that this combination treatment could be effective for metastatic breast cancer?
This trial will evaluate the combination of pembrolizumab and T-DM1 for patients with advanced breast cancer. Studies have shown that using pembrolizumab with T-DM1 is safe and manageable. Pembrolizumab helps the body's immune system fight cancer, while T-DM1 targets cancer cells directly, aiming to avoid damage to normal cells. Research has shown that T-DM1 alone is more effective than trastuzumab, another breast cancer treatment, especially for HER2-positive breast cancer. Although early data is still being gathered, these findings suggest that combining these treatments might improve patient outcomes by using both immune and targeted methods.34678
Who Is on the Research Team?
Sara Tolaney, MD MPH
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for adults with stage IV breast cancer that has spread, who have previously been treated with trastuzumab and a taxane. They must not be pregnant or breastfeeding, agree to use contraception, and have no severe allergies to the drugs being tested. Participants should not have untreated brain metastases or active infections requiring IV antibiotics.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Pembrolizumab and T-DM1 intravenously on day 1 of each 3-week cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall survival and disease progression
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- Trastuzumab-DM1
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Merck Sharp & Dohme LLC
Industry 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