Gemcitabine + Trastuzumab + Pertuzumab for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a combination of three drugs to treat advanced HER2 positive breast cancer in women who have already tried other treatments. The combination includes a chemotherapy drug called gemcitabine and two drugs, trastuzumab and pertuzumab, that stop cancer cells from growing. Pertuzumab was originally developed independently from trastuzumab and later found to work well together when combined with trastuzumab. The goal is to see if this new combination is more effective and safe.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that patients should have progression of disease on their current therapy, which might imply a change in treatment.
Is the combination of Gemcitabine, Trastuzumab, and Pertuzumab safe for humans?
The combination of Trastuzumab and Pertuzumab, often used with chemotherapy, has been studied for safety in treating HER2-positive breast cancer. Common side effects include diarrhea, rash, and nasopharyngitis (cold-like symptoms), but no new safety concerns were identified in recent studies. Continuous monitoring of Pertuzumab's safety is recommended.12345
How is the drug combination of Gemcitabine, Trastuzumab, and Pertuzumab unique for breast cancer treatment?
This drug combination is unique because it combines Gemcitabine, a chemotherapy drug, with Trastuzumab and Pertuzumab, which are both targeted therapies that work together to block the HER2 protein on cancer cells, potentially enhancing the treatment's effectiveness against HER2-positive breast cancer.678910
What data supports the effectiveness of the drug combination Gemcitabine, Trastuzumab, and Pertuzumab for breast cancer?
Who Is on the Research Team?
Chau Dang, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with stage IV HER2-positive breast cancer who've had up to three prior chemotherapies in the metastatic setting and have previously been treated with trastuzumab + pertuzumab or pertuzumab-based therapy. Participants must have a good performance status, stable brain lesions if present, normal heart function, and acceptable blood counts and liver function. Pregnant individuals or those with severe past reactions to study drugs, hepatitis B/C, or recent serious heart issues cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive gemcitabine, trastuzumab, and pertuzumab intravenously. Gemcitabine is administered weekly on days 1 and 8 every 3 weeks, trastuzumab every 3 weeks or weekly, and pertuzumab every 3 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment using progression-free survival and response criteria.
What Are the Treatments Tested in This Trial?
Interventions
- Gemcitabine
- Pertuzumab
- Trastuzumab
Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Hoffmann-La Roche
Industry Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD
Hartford HealthCare
Collaborator