Learn about a clinical research study evaluating an investigational combination regimen for people living with HER2+ breast cancer that has grown, spread, or cannot be removed by surgery.
The investigational combination of drugs involved in this clinical research study are tucatinib,* trastuzumab, and pertuzumab. Tucatinib has been approved by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Swissmedic, Health Canada, and the Therapeutic Goods Administration (TGA) in Australia for those living with HER2-positive breast cancer that has grown, spread to other parts of the body, or can’t be removed by surgery.
You will be given the study drugs in 21-day cycles. This means you’ll take tablets every day during each cycle and receive trastuzumab and pertuzumab on day 1 of each 21-day cycle. On some days, you will need to go to the clinic where the clinical research study is taking place.
The idea of taking part in a clinical research study might be scary. You should know that participant safety is our number one priority during every stage of the study process. All clinical research studies are carefully supervised, monitored, and documented. Every clinical research study is reviewed and approved by a special group of people called an Institutional Review Board (IRB) or Ethics Committee (EC), which is made up of scientists, nonscientist professionals, and members of the public. They make sure that participants’ rights are protected, and they seek to avoid exposure to unnecessary risks. IRBs and ECs will approve only studies that they think could help answer important medical questions.
For more information about clinical trials, visit
https://clinicaltrials.gov/ct2/about-studies/learn.
While the study is ongoing, a team of study doctors and nurses at the study site will closely monitor your health. If you have questions or concerns at any point throughout the study, a study staff member is available. The study staff can also tell you about their COVID-19 safety protocols.
There are also risks involved in the HER2CLIMB-05 study, including possible side effects from study treatment. This investigational drug may have little, if any, benefit to you.
Your participation is voluntary, and you are free to withdraw at any time, for any reason. Although others can help you make up your mind, the final decision is yours to make. Your privacy will be maintained throughout the study.
Participants play an important role in clinical trials. It is only through the completion of clinical trials that investigational medications can be evaluated and, if proven safe and effective, approved for a particular use.
Breast cancer develops when cells within the breast begin to grow and divide uncontrollably.1 There are different types of breast cancer that impact how breast cancer presents and how people respond to treatment.1 Both men and women can get breast cancer.2
HER2 is a protein.3 HER2 proteins are receptors on breast cells.4 A normal amount of HER2 is healthy – it helps to control how cells grow, divide, and repair themselves.4 However, having high levels of HER2 can cause the cell to grow out of control.4
If you have breast cancer, your doctor will likely test the levels of HER2 to find out if you're “positive” or “negative.” HER2+ (or HER2-positive) means that the breast cancer cells contain higher levels than normal of HER2.5 HER2+ breast cancers tend to grow and spread faster than other breast cancers.6
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A clinical research study, also known as a clinical trial, is a scientific study that evaluates the safety and effectiveness of a study medication. Qualified doctors, nurses, and other medical professionals are responsible for conducting the study.
It is only through the completion of clinical research studies that study medications can be evaluated and, if proven safe and effective, approved for a particular use. Different regulatory bodies in different countries may provide this approval after a thorough review, such as the US Food and Drug Administration (FDA). Prescription medications in use today were first proven safe and effective during research studies.
An investigational study drug is a medication that has not been approved by regulatory or health authorities (eg, the US Food and Drug Administration [FDA], European Medicines Agency [EMA], or appropriate regulatory authorities in each country) for prescription use. Before a trial ever allows people to join, it must go through approvals and reviews by organizations and agencies like the FDA as well as scientists, doctors, and community members to make sure it is generally safe and ethical for people to take part.
Tucatinib is approved by the FDA and other regulatory agencies for use in combination with trastuzumab and capecitabine in metastatic HER2+ breast cancer in certain treatment situations. However, it has not been approved in combination with trastuzumab and pertuzumab, which is why it is considered investigational in this clinical research study.