NeoAdjuvant Dynamic marker - Adjusted Personalized Therapy comparing sacituzumab govitecan+pembrolizumab vs. SoC chemotherapy in clinical stage II-III, triple-negative early breast cancer (ADAPT-TN-IV)
This research study, called ADAPT-TN-IV, is looking for people with a type of early breast cancer known as triple-negative breast cancer. It's a Phase III study, which means it’s testing new treatments compared to standard ones, hoping to prove they are better. The study compares a combination of two drugs, sacituzumab govitecan (sometimes known as Trodelvy) and pembrolizumab (sometimes known as Keytruda), against the usual chemotherapy treatment. The main goal is to see if the new combination can lead to a longer period without the cancer returning or getting worse, and to see if it can make the cancer disappear completely from the breast and lymph nodes before surgery. This helps doctors learn the best ways to treat this specific type of cancer.
At a glance
What is this study about?
This study, called ADAPT-TN-IV, is focused on helping people with a specific type of early breast cancer. This type is known as 'triple-negative breast cancer.' It's called triple-negative because the cancer cells don't have certain features (receptors for oestrogen, progesterone, or HER2 protein) that other breast cancers might have. This means some common treatments, like hormone therapy or HER2-targeted drugs, don't work for it, making it more challenging to treat.
The study is comparing two different treatment approaches. One approach is the standard chemotherapy that doctors currently use for this type of cancer. The other approach involves a new combination of two medicines: sacituzumab govitecan and pembrolizumab. Sacituzumab govitecan is designed to deliver chemotherapy directly to cancer cells. Pembrolizumab helps your body's immune system fight the cancer. By comparing these, doctors hope to find a more effective way to treat triple-negative early breast cancer.
The main aim is to see if the new drug combination can prevent the cancer from returning or spreading for a longer time, measured over 36 months. Another important goal is to see how many people have no signs of cancer left in their breast and lymph nodes after the treatment but before surgery. This is called a 'pathologic complete response' (pCR) and is a good sign that the treatment has worked very well. The study also looks at how the treatments affect people's quality of life and any side effects.
Key takeaways
- This study is for early-stage triple-negative breast cancer.
- It compares new drug combinations with standard chemotherapy.
- A main goal is to see if the cancer stays away longer with the new treatment.
- It also checks if the cancer disappears completely before surgery.
- You'll be closely monitored for treatment effects and side effects.
- The study aims to find better treatments for this specific cancer type.
Who may be eligible?
To join this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.
Crucially, you would need to have been diagnosed with triple-negative early breast cancer that is in stages II or III. This means the cancer is still in its early stages but might have grown into nearby tissues or spread to nearby lymph nodes, but not to distant parts of the body.
There will be other specific medical details your doctor will check to make sure the study is a safe and suitable option for you. This could include checking your general health and other medical conditions you might have.
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 triple-negative early breast cancer?
- Is your cancer considered Stage II or III?
- Are you able to attend regular clinic appointments and follow-up checks?
- Are you open to potentially receiving a new investigational treatment?
What does participation involve?
If you join this study, you will receive either the new combination treatment (sacituzumab govitecan and pembrolizumab) or the standard chemotherapy. Which treatment you receive will be decided by chance, like flipping a coin. Both treatments are given as infusions into a vein.
You will have regular visits to the clinic for your treatments and to have checks, like physical exams, blood tests, scans (ultrasound, mammography, or MRI), and possibly biopsies. These checks will help doctors see how you are responding to the treatment and manage any side effects. You'll also be asked about your quality of life.
The initial treatment period before any surgery will be followed by surgery, and then continued monitoring for at least 36 months (three years) to see how you are doing in the long term. The exact number and timing of visits will be detailed by the study team, but it will involve consistent follow-up.
Potential risks and benefits
Locations (1)
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Common questions
What is triple-negative breast cancer?
It's a type of breast cancer where the cells don't have three specific features that other breast cancers might have, meaning some common treatments won't work for it.
What does 'Phase III' mean for a study?
Phase III means it's a large-scale study testing a new treatment against a standard one to see if it's better or safer, before it can be widely used.
What are the main treatments being tested?
The study compares standard chemotherapy with a combination of two new drugs: sacituzumab govitecan (Trodelvy) and pembrolizumab (Keytruda).
How long will I be followed in the study?
You'll be monitored for at least 36 months (three years) after registration to see how the treatment affects your cancer in the long term.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time without it affecting your future medical care.
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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