Evaluating 6-months of HER2-targeted Therapy in Patients With HER2 Positive Early-stage Breast Cancer That Achieve a Pathological Complete Response to Neoadjuvant Systemic Therapy
This study is for people with an early form of HER2-positive breast cancer. Researchers want to see if a shorter 6-month course of HER2-targeted treatment (Trastuzumab) is effective for patients who have already had initial chemotherapy and HER2 treatment, and whose cancer has completely disappeared after that first phase. Currently, this treatment usually lasts for 12 months. The study hopes to find out if reducing the treatment time by half is safe and works just as well. This could mean fewer side effects, like heart problems, and fewer trips to the hospital, making treatment easier for patients while still keeping the cancer at bay.
At a glance
What is this study about?
This study is investigating a new way to treat early-stage breast cancer that has a specific marker called HER2. For many years, a drug called Trastuzumab has been very effective in helping to prevent HER2-positive breast cancer from coming back, often cutting the risk by almost half. This drug is usually given for a full year after initial treatments, alongside other therapies.
However, this year-long treatment can sometimes cause side effects, particularly affecting the heart. It also means frequent hospital visits and can be quite costly. Doctors are keen to find out if some patients, who respond very well to their initial cancer treatment, might need less of this drug and still get the same good results. If we can shorten the treatment time safely, it could mean fewer side effects for patients, less time spent in hospital, and potentially lower healthcare costs.
This study will focus specifically on patients whose cancer has completely disappeared from their breast and lymph nodes after they've had chemotherapy and HER2-targeted treatment before surgery. These patients have shown a very good response, and the study aims to see if giving them Trastuzumab for only 6 months, instead of 12, is just as effective in stopping the cancer from returning. This is a "real-world" study, which means it will look at how this shorter treatment works in many different hospitals.
Key takeaways
- This study evaluates if 6 months of HER2 therapy is enough for some breast cancer patients.
- It focuses on patients whose cancer completely disappeared after initial treatment.
- The usual treatment length is 12 months, but a shorter duration may reduce side effects.
- The study aims to improve patient experience and treatment methods.
- It's for early-stage, HER2-positive breast cancer.
Who may be eligible?
This study is looking for adults aged 18 or older of any gender who have early-stage breast cancer (meaning it hasn't spread to other parts of the body). Your cancer must be considered HER2-positive based on specific medical tests. You need to have received chemotherapy and HER2-targeted therapy before your surgery, and after this treatment, all the cancer in your breast and nearby lymph nodes must have completely gone away.
It's important that you have received less than 6 months of the HER2-targeted therapy before joining this study. You should also be able to understand and answer questionnaires in English or French.
You cannot join if any cancer cells remained after your initial treatment or if your cancer has spread. You also can't take part if you have any medical reasons that prevent you from safely continuing with HER2-targeted therapy, or if there's anything else that would make it difficult for you to follow the study's plan.
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?
- Do you have early-stage HER2-positive breast cancer?
- Did all your cancer disappear from your breast and lymph nodes after your initial chemotherapy and HER2 treatment?
- Have you received less than 6 months of HER2-targeted therapy so far?
- Can you understand and complete questionnaires in English or French?
What does participation involve?
If you decide to take part in this study, you will receive HER2-targeted therapy for 6 months. This treatment typically involves coming to the hospital for infusions every 3 weeks. You will have regular check-ups and tests throughout this period to monitor your salud and how you are responding to the treatment. The total duration of active treatment in the study will be 6 months, followed by follow-up appointments to check on your long-term health and ensure the cancer doesn't return.
Potential risks and benefits
Locations (1)
- The Ottawa Hospital Cancer CentreVerified postcodeOttawa, Canada
Common questions
What does 'HER2-positive breast cancer' mean?
HER2-positive means the cancer cells have too much of a protein called HER2. This protein helps cancer cells grow, and specific medicines can block it.
What is 'Trastuzumab'?
Trastuzumab is a medicine that specifically targets the HER2 protein on cancer cells, helping to stop their growth and prevent the cancer from returning.
What does 'pathological complete response' (pCR) mean?
A pCR means that after your initial chemotherapy and HER2 treatment, doctors couldn't find any remaining cancer cells in your breast or lymph nodes when they examined them under a microscope.
Why is the study looking at 6 months instead of 12 months of treatment?
Doctors want to see if giving the treatment for a shorter time (6 months) is just as effective for patients who respond very well to initial treatment, potentially reducing side effects and hospital visits without affecting outcomes.
Will my regular doctors still be involved?
Yes, your regular medical team will continue to be involved in your care and will work closely with the study team if you choose to participate.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.