Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab
This study investigates if some people with an early form of breast cancer, called triple-negative breast cancer (TNBC), who have responded very well to their initial treatment, can safely avoid further immunotherapy after surgery. Currently, after initial chemotherapy and immunotherapy, people often continue with immunotherapy for several months. This trial aims to see if simply observing patients (watching them closely without extra treatment) is just as effective as continuing pembrolizumab for preventing the cancer from returning. Researchers will compare how well both groups do and also look at their quality of life and the effects on the NHS. The study is for adults whose cancer has completely gone from the breast and lymph nodes after their first round of treatment.
At a glance
What is this study about?
Imagine you or someone you know has been diagnosed with early triple-negative breast cancer. This type of cancer is often treated with a combination of chemotherapy and a special drug called pembrolizumab (an immunotherapy) before surgery. Immunotherapy works by helping your body's own defence system fight the cancer cells.
For many patients, this initial treatment is very successful, meaning that when doctors examine the removed breast tissue after surgery, they find no cancer cells left. This is called a 'pathologic complete response,' and it's a very good sign. Currently, the usual practice is for these patients to continue taking pembrolizumab for about 27 weeks (around six months) after their surgery. This study wants to find out if this extra treatment is always necessary for everyone who has had such a good response.
The main question this study is trying to answer is: if your cancer has completely gone after your initial treatment, is it just as safe and effective to simply watch you closely (without giving more pembrolizumab) as it is to continue with the drug for another few months? The researchers believe that for some people, stopping treatment earlier might be a good option, potentially leading to fewer side effects and a better quality of life, without increasing the risk of the cancer coming back.
Key takeaways
- This study evaluates if some triple-negative breast cancer patients can safely stop immunotherapy after a good response to initial treatment.
- It compares continuing pembrolizumab with just observation after surgery.
- The goal is to see if observation is equally effective at preventing cancer recurrence and improves quality of life.
- You must have had no cancer left after your initial treatment to be eligible.
- Taking part involves regular check-ups and questionnaires over several years.
Who may be eligible?
This study is for adults (18 years or older) who have been diagnosed with early triple-negative breast cancer that was at a certain stage (Stage II or III) before they started treatment. A key requirement is that after having chemotherapy combined with pembrolizumab before surgery, and then having surgery, there must be no cancer cells left in the breast or the lymph nodes that were removed. Your doctors will confirm this after looking at the tissue under a microscope.
You also need to be fit enough for daily activities. Your breast cancer must be "triple-negative," which means it doesn't have certain features that other cancer drugs target. You must have completed at least 6 cycles of the combined chemotherapy and pembrolizumab treatment before your surgery. Finally, you would need to join the study within 12 weeks of your surgery.
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 or older?
- Do you have early-stage triple-negative breast cancer?
- Did you receive chemotherapy with pembrolizumab BEFORE your surgery?
- After your surgery, did your doctors confirm that there were NO cancer cells left in your breast or lymph nodes?
- Was your surgery within the last 12 weeks?
- Are you generally well enough for daily activities?
What does participation involve?
If you decide to take part, you'll be put into one of two groups by chance, like flipping a coin. One group will continue to receive pembrolizumab treatment, given as an infusion into a vein, every few weeks for about 27 weeks after surgery. The other group will be carefully watched without receiving further pembrolizumab.
Regardless of your group, you'll have regular check-ups and follow-up appointments. These will involve doctors examining you, blood tests, and possibly scans. You'll also be asked to complete questionnaires about your quality of life, which means how you are feeling and coping with your daily activities. There might also be requests for tissue samples (like from a biopsy) and you'll typically have follow-up for several years to see how you're doing in the long term.
Potential risks and benefits
Locations (838)
- University of Alabama at Birmingham Cancer CenterVerified postcodeBirmingham, United States· Active not recruiting
- Thomas HospitalVerified postcodeFairhope, United States· Recruiting
- Mobile Infirmary Medical CenterVerified postcodeMobile, United States· Recruiting
- University of South Alabama Mitchell Cancer InstituteVerified postcodeMobile, United States· Recruiting
- Katmai Oncology GroupVerified postcodeAnchorage, United States· Recruiting
- CTCA at Western Regional Medical CenterVerified postcodeGoodyear, United States· Recruiting
- Kingman Regional Medical CenterVerified postcodeKingman, United States· Recruiting
- Cancer Center at Saint Joseph'sVerified postcodePhoenix, United States· Recruiting
- Mayo Clinic Hospital in ArizonaVerified postcodePhoenix, United States· Recruiting
- Highlands Oncology Group - FayettevilleVerified postcodeFayetteville, United States· Recruiting
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - JonesboroVerified postcodeJonesboro, United States· Recruiting
- University of Arkansas for Medical SciencesVerified postcodeLittle Rock, United States· Recruiting
Common questions
What is 'triple-negative breast cancer'?
It's a type of breast cancer that doesn't have the three most common markers (estrogen receptor, progesterone receptor, and HER2 protein). This means it doesn't respond to treatments that target those markers, making other treatments like chemotherapy and immunotherapy very important.
What does 'pathologic complete response' mean?
It's excellent news! It means that after your initial treatment (chemotherapy and pembrolizumab before surgery), when doctors looked at the removed breast tissue and lymph nodes under a microscope, they found no remaining cancer cells. This shows the treatment was highly effective.
What is pembrolizumab and how does it work?
Pembrolizumab is a type of immunotherapy. It helps your body's immune system (its natural defence) to recognise and fight off cancer cells more effectively. It's often given through a drip into your arm.
Will I know which group I'm in?
Yes, you will know whether you are continuing with pembrolizumab or being observed. You will be assigned to a group by chance, like drawing lots, to ensure the study is fair.
How long will I be followed up if I join this study?
You will be followed up for several years to make sure researchers can fully understand the long-term effects of each approach on your health and cancer recurrence.
How to find out more
Sara Tolaney, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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