Lapatinib + Trastuzumab for HER2 Positive Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two treatments, lapatinib (Tykerb) and trastuzumab (Herceptin, Trazimera, Herzuma, or Ontruzant), to evaluate their combined effectiveness for patients with HER2-positive breast cancer that has spread locally or to other parts of the body. The goal is to determine if these medications can stop or slow tumor growth by blocking key enzymes and tumor growth pathways. People with HER2-positive breast cancer that has spread and who frequently experience issues with this type of cancer might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications, but it does prohibit certain medications that affect liver enzymes (CYP3A4 inhibitors or inducers). It's best to discuss your current medications with the trial team to see if any adjustments are needed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using lapatinib and trastuzumab together is generally safe for treating HER2-positive breast cancer. Studies indicate that this combination can improve treatment outcomes without causing excessive side effects, which remain manageable for most patients.
In one study, patients who took both drugs responded better than those who took just one. Another study found that the treatment effectively controlled the disease.
While these results are encouraging, each patient is unique. Side effects can vary, and not everyone will experience the same outcomes. Prospective trial participants should discuss with their doctor whether this treatment might be suitable.12345Why are researchers excited about this trial's treatments?
Researchers are excited about combining Lapatinib and Trastuzumab for HER2-positive breast cancer because it offers a unique dual-targeting approach. Unlike traditional treatments that might focus solely on stopping cancer cell growth, this combination targets two different aspects of the HER2 receptor, which is overactive in these cancer cells. This dual action not only has the potential to more effectively halt cancer progression but also to delay or prevent resistance to treatment, offering new hope for patients with this aggressive cancer type.
What evidence suggests that lapatinib and trastuzumab might be an effective treatment for HER2-positive breast cancer?
Research has shown that using lapatinib and trastuzumab together can effectively treat HER2-positive breast cancer. This trial will test the combination, which studies have found leads to better outcomes, with more patients experiencing a complete disappearance of cancer signs in tissue samples after treatment. Trastuzumab alone has shown success rates of 26% when used initially and 15% in later treatments. Lapatinib controls the disease in about 61.7% of patients. Together, these drugs appear more powerful against cancer cells.23567
Who Is on the Research Team?
Daneng Li, MD
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
This trial is for adults aged 60 or older with HER2 positive breast cancer that's either locally advanced or has spread to other body parts. Participants must be able to take oral meds, have a life expectancy over 12 weeks, and an ECOG status of <=2. They should not have active heart disease, infections like HIV, unstable brain metastases, or conditions affecting medication absorption.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lapatinib ditosylate orally once daily and trastuzumab intravenously once weekly or once every 3 weeks. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Long-term follow-up
Participants are periodically monitored for overall survival and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Lapatinib
- Trastuzumab
Lapatinib is already approved in United States, European Union for the following indications:
- Advanced or metastatic breast cancer in combination with capecitabine for patients whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab
- Advanced or metastatic breast cancer in combination with capecitabine for patients whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
GlaxoSmithKline
Industry Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School
Novartis
Industry Sponsor
Vasant Narasimhan
Novartis
Chief Executive Officer since 2018
MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government
Shreeram Aradhye
Novartis
Chief Medical Officer since 2022
MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania