A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy
This study, called a Phase 3 trial, investigated new ways to treat a type of breast cancer called HER2-positive. This was for people who had already received chemotherapy and other HER2-targeted treatments before surgery, but still had some cancer remaining. The study compared two different treatments: a drug called atezolizumab, which helps the body's immune system fight cancer, and another drug called trastuzumab emtansine, which is a targeted therapy. Some participants also received a dummy treatment (placebo) alongside trastuzumab. The main goal was to see if these new approaches could stop the cancer from returning. This study is no longer enrolling new participants.
At a glance
What is this study about?
This study focused on a specific type of breast cancer known as HER2-positive. If you have been diagnosed with this type of cancer and had treatment before surgery (like chemotherapy and other HER2-targeting drugs), but some cancer cells were still found after your operation, then this study was designed for people like you. The goal was to find a treatment that could lower the chance of the cancer coming back.
Researchers wanted to compare different medication combinations. One group of participants received a drug called atezolizumab along with trastuzumab emtansine. Atezolizumab is an immunotherapy, which means it works by helping your own immune system to fight the cancer. Trastuzumab emtansine is a targeted drug that delivers chemotherapy directly to cancer cells. Another group received trastuzumab emtansine with a placebo. The study was structured so that neither the participants nor their doctors knew which treatment they were receiving, to ensure fair results. This type of study is called a 'randomised, double-blind placebo-controlled' trial.
While this study is no longer accepting new patients, the information gathered from it is important for future breast cancer treatments. It helps doctors understand which treatments are most effective and safe for people with HER2-positive breast cancer, especially for those at higher risk of their cancer returning after initial treatment.
Key takeaways
- This study investigated new treatments for HER2-positive breast cancer at high risk of returning.
- It involved comparing immunotherapy (atezolizumab) and targeted therapy (trastuzumab emtansine) with standard treatment.
- The study aimed to reduce the chance of cancer coming back after surgery.
- It was a large-scale (Phase 3) trial, designed to provide strong evidence.
- The study is now closed to new participants but its findings will help future patients.
Who may be eligible?
This study was for adults aged 18 or older, of any gender. To be considered, you would have needed to have invasive HER2-positive breast cancer that was confirmed by lab tests. An important requirement was that you had already completed chemotherapy treatment before your breast cancer surgery, and this treatment must have included certain drugs like taxane and trastuzumab. Crucially, after your surgery, there must have still been some cancer cells found in your breast or nearby lymph nodes.
You also needed to be in reasonably good general health, with a good ability to perform daily activities. Your heart function, which would have been checked with a test called an LVEF, needed to be at a certain level. People with very early-stage cancers (like some T1 cancers) or those with cancer that had spread to other parts of the body (Stage IV) were not eligible. Also, if you had certain other health conditions, such as severe nerve damage, specific lung problems, autoimmune diseases, or other serious illnesses, you couldn't join. You also couldn't have previously received certain similar cancer drugs.
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.
- I had HER2-positive breast cancer.
- I had chemotherapy and trastuzumab before my breast cancer surgery.
- Some cancer was still found in my breast or lymph nodes after surgery.
- I was generally in good health and able to do my daily activities.
- My cancer had not spread to other organs (Stage IV).
What does participation involve?
As this study is now closed to new participants, we can't describe what taking part would involve in real-time. However, typically, a study like this would involve regular hospital visits for check-ups, blood tests, and to receive the study medications. You would have had follow-up appointments over several years to monitor your health and see if the cancer returned. The total duration of active treatment and follow-up can vary greatly in clinical trials, but typically involves a commitment over a number of years.
Potential risks and benefits
Locations (238)
- Alabama OncologyVerified postcodeBirmingham, United States
- Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical CenterVerified postcodeBuena, United States
- UCLA Medical CenterVerified postcodeSanta Monica, United States
- Innovation Clinical Research InstituteVerified postcodeWhittier, United States
- Florida Cancer SpecialistsVerified postcodeWest Palm Beach, United States
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb HospitalVerified postcodeCarrollton, United States
- University of IowaVerified postcodeIowa City, United States
- New England Cancer SpecialistsVerified postcodeWestbrook, United States
- The Valley HospitalVerified postcodeParamus, United States
- Levine Cancer InstituteVerified postcodeCharlotte, United States
- Abramson Cancer Center; Univ of Pennsylvania; Clinical Research UnitVerified postcodePhiladelphia, United States
- The West ClinicVerified postcodeGermantown, United States
Common questions
What is HER2-positive breast cancer?
HER2-positive breast cancer has a lot of a protein called HER2, which helps cancer cells grow. Treatments targeting this protein are often very effective.
What does 'adjuvant' mean?
In cancer treatment, 'adjuvant' treatment is given after the main treatment (like surgery) to lower the chance of the cancer coming back.
What is a 'placebo'?
A placebo is a dummy treatment that looks like the real drug but contains no active medicine. It's used in studies to fairly compare new treatments.
What does Phase 3 mean for a study?
Phase 3 studies are large trials that compare a new treatment with existing standard treatments to confirm its effectiveness and safety before it can be approved for general use.
Is this study still looking for patients?
No, this particular study is no longer accepting new patients. It closed for new screening on June 4, 2024.
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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