Lapatinib + Trastuzumab for HER2 Positive Breast Cancer
Trial Summary
What is the purpose of this trial?
This phase II trial studies the side effects and how well lapatinib ditosylate and trastuzumab work in treating older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or to other parts of the body (metastatic). Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or tumor cancer-killing substances to them. Giving lapatinib ditosylate together with trastuzumab may kill more tumor cells.
Research Team
Daneng Li, MD
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
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
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
Treatment Details
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