Trastuzumab Emtansine for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called trastuzumab emtansine to determine if it can shrink or halt the growth of cancers with a specific genetic change known as HER2 amplification. The treatment combines targeted therapy and chemotherapy, designed to attack cancer cells directly. Participants receive the treatment through an IV every three weeks. Suitable candidates for this trial have cancers with HER2 amplification but do not have breast or stomach cancer and have not received certain similar treatments before. As a Phase 2 trial, the 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 be on certain blood thinners like warfarin or long-acting anti-platelet agents like clopidogrel. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that trastuzumab emtansine is likely to be safe for humans?
Research has shown that trastuzumab emtansine, or T-DM1, is generally well-tolerated. It combines a targeted therapy with a chemotherapy drug. Studies have found it safe for treating certain types of cancer.
Some patients might experience side effects like tiredness, nausea, and low blood cell counts. More serious effects, such as liver or heart problems, are less common but can occur. Monitoring for these during treatment is important.
The safety of trastuzumab emtansine has been tested in cancer patients before. While it may cause more side effects than trastuzumab alone, it remains a reliable option for those with HER2-positive cancers. Patients should discuss any concerns with their healthcare provider to understand what to expect during treatment.12345Why do researchers think this study treatment might be promising?
Trastuzumab emtansine is unique because it combines the targeted action of trastuzumab, which homes in on the HER2 protein commonly found in some cancers, with a powerful chemotherapy agent called emtansine. This combination allows it to deliver chemotherapy directly to the cancer cells while minimizing damage to healthy cells, which is different from traditional treatments that often affect both. Researchers are excited because this targeted approach can potentially lead to fewer side effects and more effective treatment outcomes compared to standard chemotherapy options.
What evidence suggests that trastuzumab emtansine might be an effective treatment for cancer?
Research has shown that trastuzumab emtansine, or T-DM1, effectively treats certain cancers with a genetic change called HER2 amplification. Studies indicate that T-DM1 can significantly shrink cancer or halt its growth. In previous studies, 75.7% of patients experienced cancer shrinkage, and some had complete responses, meaning no cancer was detectable. Additionally, T-DM1 has helped patients live longer and delay disease progression compared to some other treatments. This targeted therapy works by attaching to cancer cells and delivering a chemotherapy drug directly to them, enhancing its effectiveness. Participants in this trial will receive trastuzumab emtansine as the investigational treatment.678910
Who Is on the Research Team?
Komal Jhaveri
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
This trial is for patients with cancers like lymphoma or solid tumors that have a specific genetic change (HER2 amplification). They must not have had certain prior treatments, agree to use contraception, and meet health criteria such as adequate hemoglobin levels and heart function. People with breast or gastric cancer, severe allergies to the drug being tested, or serious nerve damage are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive trastuzumab emtansine intravenously over 30-90 minutes on day 1, with cycles repeating every 21 days in the absence of disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-ups every 3 months if less than 2 years from study entry, and then every 6 months for year 3
What Are the Treatments Tested in This Trial?
Interventions
- Trastuzumab Emtansine
Trastuzumab Emtansine is already approved in United States, European Union, United Kingdom for the following indications:
- Metastatic breast cancer in patients whose tumors overexpress the HER2 protein and who have received prior therapy with trastuzumab and a taxane, either separately or in combination.
- Adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment
- Metastatic breast cancer in patients whose tumors overexpress the HER2 protein and who have received prior therapy with trastuzumab and a taxane, either separately or in combination.
- Metastatic breast cancer in patients whose tumors overexpress the HER2 protein and who have received prior therapy with trastuzumab and a taxane, either separately or in combination.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor