A Phase IIIB, Multinational, Multicenter, Randomized, Open-Label Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administrationin Participants with Early or Locally Advanced/ Inflammatory HER2-Positive Breast Cancer
This research study is about treating a specific type of breast cancer called HER2-positive breast cancer, which can be early, locally advanced, or inflammatory. The main goal is to find out if patients prefer to receive a new combination medicine called Phesgo at home rather than in a hospital setting. This medicine is given as an injection under the skin. Researchers will also look at how effective the treatment is, based on whether the cancer cells disappear, and how it affects patients' quality of life. The study will also track any side effects to ensure the treatment is safe for patients.
At a glance
What is this study about?
This study is designed for people with HER2-positive breast cancer, which includes cases that are caught early, have spread a bit nearby (locally advanced), or are inflamed. HER2-positive means the cancer cells have too much of a protein called HER2, which helps them grow. There are now medicines that specifically target this protein.
The main point of this research is to see if patients prefer getting their cancer treatment, a combination medicine called Phesgo (which contains pertuzumab and trastuzumab), at home rather than having to go to the hospital. This medicine is given as an injection just under the skin. We want to understand if receiving treatment in the comfort of one's own home can make a real difference to patients' experience.
Beyond patient preference, the study will also carefully look at how well the treatment works to shrink or get rid of the cancer. Researchers will also be checking on patients' overall well-being and quality of life during the treatment. Safety is a top priority, so all potential side effects will be closely monitored. This helps doctors understand the full picture of using this treatment outside the hospital.
Key takeaways
- Compares home vs. hospital treatment for HER2-positive breast cancer.
- Using a new combined injection called Phesgo.
- Mainly focuses on patient preference for where they receive treatment.
- Also evaluates how well the treatment works and any side effects.
- Aims to improve convenience and quality of life for patients.
Who may be eligible?
To join this study, participants generally need to be at least 18 years old. Both men and women can take part.
You would need to have been diagnosed with HER2-positive breast cancer. This includes breast cancer that is in its early stages, has grown into nearby tissues, or is causing inflammation. Your doctors will be able to tell you if your cancer fits these descriptions.
There might be other specific health requirements or conditions that would mean you can or cannot take part. These are put in place to ensure the study is safe for everyone involved and that the results are as clear as possible. Your doctor will discuss all the details with 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?
- Have you been diagnosed with HER2-positive breast cancer?
- Is your breast cancer early, locally advanced, or inflammatory?
- Are you able to attend regular hospital appointments as required?
- Are you willing to complete questionnaires about your experience?
What does participation involve?
If you decide to join this study, you would receive treatment for your HER2-positive breast cancer. Some of this treatment, specifically the Phesgo injection, would be given either at home or in the hospital, depending on which group you are in and your preferences. You would also receive other standard cancer treatments, such as infusions at the hospital.
Throughout the study, you would have regular appointments for check-ups, blood tests, and scans to monitor your health and how the treatment is working. You would also be asked to complete questionnaires about your preferences for treatment location and your quality of life. The exact number of visits and the duration of the study would depend on your specific treatment plan, but cancer treatments like this often involve several months of therapy followed by ongoing monitoring.
Potential risks and benefits
Locations (3)
- —UnverifiedSpain
- —UnverifiedBulgaria
- —UnverifiedCroatia
Common questions
What is HER2-positive breast cancer?
It's a type of breast cancer where the cancer cells have too much of a protein called HER2, which helps them grow quickly.
What is Phesgo?
Phesgo is a combination medicine that targets the HER2 protein, given as an injection under the skin for HER2-positive breast cancer.
Why would I get treatment at home?
This study is looking into whether patients prefer to receive their Phesgo injections at home instead of having to travel to the hospital.
Will I still need to go to the hospital?
Yes, even if you receive some injections at home, you will still have hospital appointments for other treatments and regular check-ups.
What are adverse events?
These are any unwanted or unexpected medical problems that happen during the study, like side effects from the medication.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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