A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer
This study is for people in the UK with HER2-positive breast cancer that has spread (metastatic disease). If your cancer has continued to grow despite previous treatments (like T-DXd), this study might be for you. It aims to find out if a new drug called zanidatamab, when given with chemotherapy, is more effective and safer than a standard drug called trastuzumab, also given with chemotherapy. Both zanidatamab and trastuzumab are types of medicines that specifically target the HER2 protein on cancer cells. Researchers want to compare how well these combinations work, their side effects, and how they affect a patient's daily life and physical ability. The study is in Phase 3, meaning it's a large trial testing a promising treatment against a current standard.
At a glance
What is this study about?
This research study is looking for better treatments for a type of breast cancer called HER2-positive metastatic breast cancer. 'Metastatic' means the cancer has spread to other parts of the body. 'HER2-positive' means the cancer cells have a lot of a protein called HER2 on their surface, which helps them grow. Unfortunately, sometimes current medicines stop working, or patients can't tolerate them.
The main aim of this study is to compare two different treatment approaches. One approach uses a newer drug called zanidatamab, combined with chemotherapy. The other approach uses a standard drug called trastuzumab (often known by its brand name, Herceptin), also combined with chemotherapy. Both zanidatamab and trastuzumab are designed to block the HER2 protein, hopefully stopping the cancer from growing. Researchers want to see which combination works better at shrinking the cancer and keeping it under control, and which combination has fewer side effects.
Taking part in this study would involve receiving one of these two drug combinations. You wouldn't get to choose which one you receive; it would be decided by chance, like flipping a coin. The chemotherapy drug you receive would be chosen by your doctor from a few standard options. The study will also look at how patients feel on these treatments, including their general well-being and ability to do daily activities. This research is important because it could lead to new and more effective treatments for people living with HER2-positive metastatic breast cancer.
Key takeaways
- This study is for HER2-positive breast cancer that has spread and needs new treatment options.
- It compares a new drug (zanidatamab) with a standard one (trastuzumab), both with chemotherapy.
- Participation involves regular clinic visits, assessments, and taking study medication.
- You will be closely monitored for how the treatment is working and any side effects.
- The goal is to find more effective and safer treatments for this type of cancer.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old. Your cancer must be confirmed as HER2-positive breast cancer that has spread to other parts of your body. It's important that your cancer has already been treated with a specific type of medication (T-DXd) and has either progressed or you couldn't tolerate that treatment.
You also need to have received at least two, but no more than four, previous HER2-targeted treatments for your metastatic breast cancer. If you had HER2-targeted treatment before surgery (neo-adjuvant) or after surgery (adjuvant) and your cancer returned within six months, that counts as one of your previous treatments. Your doctor will choose a chemotherapy drug for you from a list of standard options, and you must be suitable for one of them.
Other important points for eligibility include having a good general health status, with your key organs (like heart, liver, and kidneys) working well enough. If you have cancer that has spread to your brain but it's been treated and isn't currently active, you might still be able to join. Your doctor will also need to believe you have a life expectancy of at least six months. They will check all these details carefully to make sure the study is safe and appropriate for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Is your breast cancer HER2-positive and has it spread to other parts of your body?
- Has your cancer progressed on a previous treatment called T-DXd (or you couldn't tolerate it)?
- Have you had at least 2, but no more than 4, previous HER2-targeted treatments for your metastatic cancer?
- Are you generally well enough for chemotherapy and other study treatments?
- Are your heart, liver, and kidneys working well enough, as determined by your doctor?
What does participation involve?
If you decide to join this study, you will be assigned by chance (like drawing lots) to receive one of two treatment combinations: either zanidatamab plus chemotherapy, or trastuzumab plus chemotherapy. The chemotherapy drug will be chosen by your doctor from a few standard options (Eribulin, Vinorelbine, Gemcitabine, or Capecitabine).
Taking part will involve regular visits to the clinic for your treatment and check-ups. During these visits, the study team will carry out various assessments, such as blood tests, scans, and physical examinations, to monitor your health and how well the treatment is working. You will also be asked to complete questionnaires about your symptoms and how you are feeling, which helps the researchers understand the treatment's impact on your daily life. The total duration of your participation in the study will depend on how you respond to the treatment and the study's protocol, but there will be regular follow-up appointments even after treatment ends.
Potential risks and benefits
Locations (166)
- Mayo Clinic Scottsdale - PPDSVerified postcodePhoenix, United States· Recruiting
- Arizona Oncology Tucson - WilmotVerified postcodeTucson, United States· Withdrawn
- University of Arizona Cancer CenterVerified postcodeTucson, United States· Recruiting
- The Oncology Institute Of Hope And InnovationVerified postcodeCerritos, United States· Recruiting
- Los Angeles Hematology Oncology Medical Group GlendaleVerified postcodeGlendale, United States· Recruiting
- USC-Norris Comprehensive Cancer Center - Investigational Drug Service IDSVerified postcodeLos Angeles, United States· Recruiting
- UCSF at Mission Bay MBVerified postcodeSan Francisco, United States· Recruiting
- University of Colorado-Cancer Center-PPDSVerified postcodeAurora, United States· Recruiting
- Rocky Mountain Cancer CentersVerified postcodeDenver, United States· Recruiting
- Medstar Georgetown University HospitalVerified postcodeWashington D.C., United States· Recruiting
- Washington Cancer CenterVerified postcodeWashington D.C., United States· Recruiting
- Florida Cancer Specialists Research SouthVerified postcodeFort Myers, United States· Recruiting
Common questions
What is HER2-positive breast cancer?
It's a type of breast cancer where the cancer cells have a lot of a protein called HER2, which helps them grow. Treatments that target this protein can often be very effective.
What does 'metastatic' mean?
Metastatic means the cancer has spread from where it started to other parts of the body, such as the bones, liver, or lungs.
What's the difference between zanidatamab and trastuzumab?
Both are drugs designed to target the HER2 protein on cancer cells. Trastuzumab (Herceptin) is a standard treatment, while zanidatamab is a newer drug being tested to see if it works as well or better, particularly after other treatments haven't helped.
Will I know which treatment I am receiving?
No, you will be assigned to one of the two treatment groups by chance. This is important to ensure the study results are fair and unbiased.
What if the treatment isn't working for me?
Your health will be closely monitored throughout the study. If the treatment isn't working or if you experience severe side effects, the study team will discuss your options with you, and you can withdraw from the study at any time.
How to find out more
Clinical Trial Disclosure & Transparency
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.