Pembrolizumab and Chemotherapy Treatment or no Treatment Guided by the Level of TILs in Resected Early-stage TNBC
This study is for people with early-stage triple-negative breast cancer (TNBC), a type that affects younger women more often. Doctors usually recommend surgery and chemotherapy for TNBC, but this study questions if everyone needs the full chemotherapy treatment. Researchers are looking at special immune cells called TILs (tumour-infiltrating lymphocytes) found within the cancer. If a tumour has a lot of these TILs, it might mean the body is already fighting the cancer well. The study aims to see if patients with higher levels of TILs can have their chemotherapy reduced or even completely avoided, while still getting good results. It compares different treatment plans, with some patients potentially receiving a new drug called Pembrolizumab and paclitaxel, while others might receive no chemotherapy at all and just be carefully monitored.
At a glance
What is this study about?
This research is looking into how we treat a specific type of breast cancer called triple-negative breast cancer (TNBC). This type of cancer tends to affect younger women and can be more aggressive than other types. Currently, most people with early-stage TNBC have surgery, often followed by chemotherapy and sometimes radiotherapy. While chemotherapy is very effective, it can also have long-lasting side effects that affect a person's quality of life.
Doctors have noticed that some patients with early-stage TNBC, especially those with small tumours and no spread to lymph nodes, seem to do very well, even without extensive chemotherapy. This study focuses on a key factor: 'tumour-infiltrating lymphocytes' (TILs). These are immune cells that have entered the tumour, suggesting the body's immune system is already trying to fight the cancer. The idea is that if a tumour has many TILs, it might not need as much chemotherapy, or perhaps none at all.
The ETNA study is designed to explore this idea. It aims to find out if it's safe and effective to reduce or even skip chemotherapy for certain patients with early-stage TNBC who have high levels of TILs. The study will divide patients into different groups based on their TIL levels and age. Some groups might receive a combination of Pembrolizumab (a new type of immune-boosting drug) and Paclitaxel (a chemotherapy drug), while others with very high TILs might just be monitored closely without any active cancer treatment, to see if they still achieve excellent outcomes. This could help tailor treatments more precisely, potentially reducing side effects for many patients.
Key takeaways
- This study evaluates different treatments for early-stage triple-negative breast cancer.
- It investigates if high levels of immune cells (TILs) in the tumour mean less chemotherapy is needed.
- Some patients may receive a new immune-boosting drug (Pembrolizumab) and chemotherapy (Paclitaxel).
- Other patients with very high TILs might receive no chemotherapy and be closely monitored.
- The study aims to personalise treatment, potentially reducing side effects for some.
Who may be eligible?
This study is looking for people aged 18 or older who have been diagnosed with early-stage triple-negative breast cancer. To be suitable, your cancer needs to be a specific size (not too large) and must not have spread to your lymph nodes or other parts of your body.
Your breast cancer must have been completely removed by surgery, either through breast-conserving surgery or a mastectomy. After surgery, the edges of the removed tissue should be clear of cancer cells. You will also need to have had a check of your lymph nodes under your arm to confirm they are clear. Your general health should be good, meaning you can carry out your daily activities without too much difficulty.
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 triple-negative breast cancer?
- Has your breast cancer been completely removed by surgery?
- Do your lymph nodes show no sign of cancer spread?
- Is your general health good, allowing you to carry out daily activities?
What does participation involve?
If you join this study, you'll be placed into one of two groups based on the level of immune cells (TILs) in your tumour and your age.
One group will receive a drug called Pembrolizumab every three weeks for nine cycles, alongside Paclitaxel chemotherapy once a week for 12 cycles. Each cycle involves specific appointments for treatment. The other group will not receive any active treatment; instead, they will have regular check-ups every six months to monitor their health carefully. The total duration of your active treatment or monitoring will vary depending on your assigned group, and the study team will explain all scheduled visits and assessments in detail.
Potential risks and benefits
Locations (44)
- CHU Amiens Picardie_Site SudVerified postcodeAmiens, France· Recruiting
- Institut Sainte CatherineVerified postcodeAvignon, France· Recruiting
- Centre Hospitalier de la Côte BasqueVerified postcodeBayonne, France· Recruiting
- Institut BergoniéVerified postcodeBordeaux, France· Not yet recruiting
- Polyclinique Bordeaux Nord AquitaineVerified postcodeBordeaux, France· Recruiting
- Centre François BaclesseVerified postcodeCaen, France· Recruiting
- Pôle Santé RepubliqueVerified postcodeClermont-Ferrand, France· Recruiting
- Centre Jean PerrinVerified postcodeClermont-Ferrand, France· Recruiting
- Centre Georges-François LeclercVerified postcodeDijon, France· Not yet recruiting
- Hôpital Franco-Britannique-Fondation Cognacq-JayVerified postcodeLevallois-Perret, France· Not yet recruiting
- CHU de LimogesVerified postcodeLimoges, France· Recruiting
- Centre Léon BérardVerified postcodeLyon, France· Recruiting
Common questions
What is triple-negative breast cancer?
It's a type of breast cancer that doesn't have three specific features (estrogen or progesterone receptors, and HER2 protein), making typical hormone therapies or HER2-targeted drugs ineffective.
What are TILs?
TILs, or Tumour-Infiltrating Lymphocytes, are immune cells (like white blood cells) that have moved into your cancer. A high number of TILs can be a sign your body's immune system is fighting the cancer.
Is Pembrolizumab chemotherapy?
No, Pembrolizumab is an immunotherapy drug, not traditional chemotherapy. It works by helping your own immune system fight the cancer more effectively.
Why might I not get chemotherapy?
If your tumour has a very high level of TILs, meaning your body's immune system is already reacting strongly to the cancer, the study is exploring whether less or no chemotherapy is needed for you.
How long will the study last for me?
The active treatment involves 9 cycles of Pembrolizumab and 12 cycles of Paclitaxel, or regular check-ups every six months if you are in the monitoring group. The overall follow-up period will be discussed by your doctor.
How to find out more
Telma ROQUE, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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