Chemotherapy-free Trastuzumab and Pertuzumab in HER2-positive Breast Cancer: FDG-PET Response-adapted Strategy.
This study is for people with a type of breast cancer called HER2-positive. We want to see if treating this cancer with two special drugs, Herceptin and Perjeta, sometimes combined with other hormone treatments, can shrink tumours before surgery without needing chemotherapy right away for everyone. We're using special scans to see early on how well the treatment is working. This helps us decide if chemotherapy might be needed later or not. The study also aims to check how well these treatments prevent the cancer from coming back over three years. We hope to find better ways to personalise breast cancer treatment to improve outcomes for patients.
At a glance
What is this study about?
This study is focused on people who have a specific type of breast cancer called HER2-positive breast cancer. This means the cancer cells have a lot of a protein called HER2, which helps them grow. The study is trying to find out if we can treat this kind of cancer effectively using two special drugs, Herceptin (pertuzumab) and Perjeta (trastuzumab), which target the HER2 protein, sometimes with hormone therapy, *before* someone has surgery. The idea is to shrink the tumour as much as possible first.
What makes this study special is that it uses a new approach. We'll be using special scans (FDG-PET scans) early in the treatment to see how much the tumour has shrunk. This helps doctors see which patients are responding well to the Herceptin and Perjeta treatment alone, and which patients might need chemotherapy added on. This could mean some people avoid chemotherapy altogether, or only have it if necessary.
The main goals are to see how well this 'chemotherapy-free' approach works at shrinking tumours before surgery, and to track patients for three years to see how well it prevents the cancer from coming back. By personalising treatment based on how the tumour responds, we hope to make treatment more effective and reduce side effects for people with HER2-positive breast cancer.
Key takeaways
- Targets HER2-positive breast cancer.
- Tests Herceptin and Perjeta, sometimes without initial chemotherapy.
- Uses scans to tailor treatment.
- Aims to reduce chemotherapy side effects for some.
- Compares different treatment plans.
- Includes long-term follow-up for three years.
Who may be eligible?
This study is looking for both women and men, aged 18 or older, who have been diagnosed with early-stage, operable HER2-positive breast cancer. Your cancer must be confirmed as HER2-positive by special tests.
To join, your overall health should be good, meaning you can carry out your daily activities without much trouble. Your latest scans or tests should show your tumour is a certain size, typically at least 1.5 centimetres. Also, your blood tests must show that your kidneys, liver, and blood cell counts are working well enough to safely receive the study treatments.
You cannot have had any chemotherapy, radiation, or anti-HER2 treatments for your breast cancer before this study. If you have other serious health conditions that might interfere with the study treatments, you may not be able to participate. The study team will review all your medical information carefully to see if you're a good fit.
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 newly diagnosed, operable HER2-positive breast cancer?
- Have you started any previous cancer treatments for this breast cancer?
- Are you in generally good health and able to do your daily activities?
- Are your blood tests for kidney, liver, and blood count within a healthy range?
What does participation involve?
If you join this study, you'll be assigned by chance to one of two main groups. One group will get Herceptin and Perjeta along with chemotherapy (docetaxel and carboplatin). The other group will receive Herceptin and Perjeta, possibly with hormone therapy depending on your cancer type. You'll have special scans (PET/CT scans) at the start and again after about two months to see how your tumour is responding. Depending on these scan results, your treatment plan might be adjusted.
All treatments will be given over several months before your surgery. After surgery, you'll continue with Herceptin and Perjeta for up to 18 cycles (about a year), plus any other standard treatments like hormone therapy or radiotherapy, as advised by your doctors. You'll have regular follow-up appointments and scans to monitor your health and ensure the treatment is effective. The total duration of the active treatment phase can be around a year and a half, with follow-up for three years.
Potential risks and benefits
Locations (56)
- Institute Jules BordetVerified postcodeBrussels, Belgium
- CLCC d'Auvergne. Centre Jean Perrin.Verified postcodeClermont-Ferrand, France
- Institute de Cancerologie de LaurraineVerified postcodeNancy, France
- Groupe Hospitalier DiaconessesVerified postcodeParis, France
- Hopital TenonVerified postcodeParis, France
- Hospital Georges PompidouVerified postcodeParis, France
- Centre Paul StraussVerified postcodeStrasbourg, France
- Institut Claudius RégaudVerified postcodeToulouse, France
- Kliniken Essen MitteVerified postcodeEssen, Germany
- Klinikum der Med. Fakultät HalleVerified postcodeHalle, Germany
- National center for tumor disease NCTVerified postcodeHeidelberg, Germany
- Städtisches Klinikum "St. Georg" LeipzigVerified postcodeLeipzig, Germany
Common questions
What is HER2-positive breast cancer?
It's a type of breast cancer where cancer cells have too much of a protein called HER2, which makes them grow faster.
What are Herceptin and Perjeta?
These are special drugs that target the HER2 protein on cancer cells, helping to stop their growth.
What does 'chemotherapy-free' mean in this study?
It means some patients might get Herceptin and Perjeta without chemotherapy first, reducing side effects for those who respond well.
What is an FDG-PET scan?
It's a special scan that helps doctors see how active or 'metabolic' your cancer cells are, showing how well treatment is working.
How long will I be in this study?
The active treatment phase could last about 18 months, with follow-up appointments for a total of three years.
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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