Lapatinib + Trastuzumab for Breast Cancer
(HELEX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new breast cancer treatment using a combination of drugs: lapatinib (Tykerb) and trastuzumab (Herceptin), with letrozole (Femara) added for some participants. The goal is to determine if this combination can effectively target and treat breast cancers that overexpress HER2, a protein that can promote tumor growth. The trial seeks women with locally advanced, HER2-positive breast cancer, meaning their cancer has high levels of this specific protein. Participants will be divided into two groups, one receiving a 24-week treatment and the other a 12-week treatment. Women with other serious health conditions or previous breast cancer treatments in the last five years are not eligible. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot take any investigational drugs or lapatinib prohibited medications while participating.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using lapatinib and trastuzumab together has been safe in past studies. For example, one study found that patients who took both drugs responded well, achieving good control over their cancer. Most participants did not experience severe side effects, indicating the combination was generally well-tolerated.
Another study demonstrated that these drugs effectively controlled the disease. Most patients could continue the treatment, suggesting it was manageable for them.
Both lapatinib and trastuzumab are already used to treat breast cancer, providing extensive safety information. This makes using both drugs together a well-researched option with a strong safety record. However, like any treatment, side effects can occur, so discussing these with a doctor is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Lapatinib and Trastuzumab for breast cancer because it targets cancer cells in two powerful ways. Unlike some treatments that focus on either HER2 or hormone receptors, this combo addresses both, potentially making it effective for a broader range of patients. Lapatinib blocks signals that encourage cancer cell growth, while Trastuzumab attaches to the HER2 protein on cancer cells, marking them for destruction. For patients with hormone receptor-positive cancers, adding Letrozole helps by further disrupting cancer growth fueled by hormones. This multi-pronged approach could lead to better outcomes compared to current treatments that often target just one pathway.
What evidence suggests that this trial's treatments could be effective for breast cancer?
Research has shown that combining lapatinib and trastuzumab can be effective for certain breast cancers, particularly HER2-positive breast cancer, where cancer cells have high levels of the HER2 protein. One study found that using both drugs together resulted in no detectable cancer cells in about 47% of cases, outperforming the use of either drug alone. In studies with mice, this combination also reduced tumor growth and sometimes caused tumors to disappear completely. In this trial, participants will receive either a 24-week or a 12-week regimen of lapatinib plus trastuzumab. Those who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy. Overall, evidence suggests that using lapatinib and trastuzumab together targets cancer cells more effectively than using them separately.24678
Who Is on the Research Team?
Mothaffar Rimawi, MD
Principal Investigator
Baylor College of Medicine
Are You a Good Fit for This Trial?
This trial is for women over 18 with advanced breast cancer larger than 2 cm, HER2 positive, and no Stage IV disease. They must have a life expectancy over 6 months, good performance status, normal organ function tests, and no other cancers or severe illnesses in the last five years. Participants cannot be pregnant and must agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lapatinib plus trastuzumab for either 12 weeks or 24 weeks, with endocrine therapy for ER/PR positive patients
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants may continue to receive lapatinib plus trastuzumab in an extended regimen to assess long-term safety and tolerability
What Are the Treatments Tested in This Trial?
Interventions
- Lapatinib
- Letrozole
- 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?
Baylor Breast Care Center
Lead Sponsor
Translational Breast Cancer Research Consortium
Collaborator
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