Breast Cancer Clinical Trials and Other Research
Clinical trials at MSK
At MSK, we can offer some people the latest treatments possible through our clinical trials. In fact, almost every cancer treatment used today began as a clinical trial.
MSK is a leader in cancer clinical trials. We often have many trials at a time, researching different types of cancers.
MSK is home to one of the largest clinical trial programs in the country. This means that we offer more cancer clinical trials than many other cancer centers in the U.S.
We offer clinical trials in Manhattan and at some of our regional locations, including:
- Long Island: Commack and Nassau
- New Jersey: Basking Ridge, Bergen, and Monmouth
- Westchester: West Harrison
MSK runs one of the country’s largest cancer clinical trials programs. An MSK clinical trial may give you access to new treatments that are not yet available at most hospitals. Watch our short video that can help you decide if a clinical trial is right for you.
MSK experts can help you understand your choices and whether a clinical trial is right for you.
There are different kinds of clinical trials. These research studies help find new and better ways to prevent, diagnose, and treat cancer. They also may help support people living with cancer.
- Treatment trials test new therapies for breast cancer. Treatment trials test new drugs, drug combinations, and devices. They test new ways of doing procedures, surgery, or radiation therapy. They also test treatments that could have fewer side effects.
- Prevention trials test better ways to prevent people from getting breast cancer or lower the chances people will get breast cancer.
- Diagnostic trials study better tests and procedures used to diagnose breast cancer.
- Screening trials test better ways to find breast cancer, even before you have symptoms.
- Quality-of-life trials study ways to help people with breast cancer live more comfortably.
Joining a clinical trial is voluntary. The choice is yours. You can stop anytime if you feel uncomfortable or do not want to stay in the trial.
In all MSK clinical trials, our doctors and scientists work closely together. Their job is to make sure people who join clinical trials are kept safe.
Before you decide to join a clinical trial, MSK researchers will talk with you about what to expect. They will talk about any possible issues and answer all your questions.
Clinical trials are not just for people who have advanced cancer. They’re not just for people who tried all other treatments.
You may have many questions about cancer research, such as:
- Do you have to pay to join a clinical trial?
- What is an informed consent and why is it so important?
- What if you get a placebo (pluh-SEE-boh)? (A placebo is something that’s not a real treatment.)
Clinical trials are research studies. All clinical trials are done in steps, called phases. These phases are numbered 0, 1, 2, 3, and 4 (0, I, II, III, and IV).
New cancer treatments must go through different phases before they’re available for everyone. If the treatment is successful in one phase, it will move on to the next one. People most often take part in just one phase of a clinical trial.
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Phase 1
The first step in testing a new treatment is called a phase 1 clinical trial. Researchers want to learn the right dosage of a drug that works best for a certain type of cancer. They want to understand how the treatment affects the body.
Sometimes the treatments work, but researchers do not know for sure they will work. That’s why phase 1 studies most often involve only 20 to 80 people.
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Phase 2
A phase 2 clinical trial most often studies how well a new treatment works in a bigger group. It can involve up to 100 people who have a similar type of cancer. Treatment uses the dose and method that the phase 1 trial found was safest and worked best.
Some phase 2 research studies use a method called randomization to assign people to a treatment group. People are chosen by chance to join a group.
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Phase 3
Phase 3 clinical trials compare new breast cancer treatments with standard treatments. They often involve between 300 and 3,000 people.
In phase 3 trials, researchers try to see which treatment is safer and works best. They test which treatment helps people live longer, with a better quality of life. They look for whether there are fewer side effects, and whether cancer came back in fewer people.
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Phase 4
A phase 4 clinical trial studies a treatment after the FDA approves it. It assesses the side effects, risks, and benefits of a drug or other therapy. The trial lasts a long period of time and tests more people than phase 3 trials. Thousands of people are in a phase 4 trial.
There are no phase 4 clinical trials at MSK.
Open breast cancer clinical trials at MSK
As a research institution, MSK runs one of the world’s largest cancer clinical trials programs.
Demystifying Clinical Trials: A Guide to The Science of Hope
Dr. Diane Reidy-Lagunes talks with Dr. Alex Drilon, Chief of MSK’s Early Drug Development Service. They answer the most common questions about joining clinical trials.
MSK has hundreds of clinical trials aimed at improving care for many types of cancer. We have more than 900 cancer clinical trials at MSK. Our experts can talk with you about which clinical trials may be right for you.
You can read about some of the areas we’re exploring right now in our breast cancer clinical trials.
- We’re studying how to treat breast cancer that has spread to the brain: Our researchers are evaluating if a new drug therapy is safe and effective in people with breast cancer that has spread to the brain.
- We’re assessing heart problems caused by breast cancer treatment: Some breast cancer treatments can worsen the heart’s ability to pump as well as it should. Our team is exploring a new drug for heart problems caused by breast cancer treatment.
- We’re learning how breast cancer treatment can affect sexual and reproductive health over several years. MSK researchers are monitoring women ages 50 and younger to learn more about early menopause, and sexual or fertility problems.
- We’re testing whether aerobic training may help people being treated for breast cancer. Our team is comparing different amounts of exercise on making the heart and lungs stronger during breast cancer treatment.
MSK’s goal is to help everyone who is eligible to join the latest clinical trials, no matter where you live. Our Cancer Health Equity Research Program is a special partnership between MSK researchers and community doctors. It brings MSK clinical trials to people at their local hospitals.
Innovations at MSK
Our experts are always finding new ways to treat breast cancer and manage side effects. Explore breast cancer news from MSK.
This patient group has traditionally done poorly, and adding the third drug, inavolisib, really made a big difference,” says medical oncologist Dr. Komal Jhaveri, who helped lead the trial.
Common questions about MSK’s breast cancer clinical trials
Are you thinking about joining a research study as part of your cancer care? It’s normal to have questions about clinical trials. Here are the answers to some of the most common questions we get from our patients about clinical trials.
Do I have to pay to be in a breast cancer clinical trial?
People often do not pay extra out-of-pocket costs for treatments studied in a trial. Most often, the clinical trial’s sponsor pays for all research-related costs and any special testing.
We will ask you or your health insurer to pay for anything that’s standard cancer treatment. Examples are routine tests, treatments, or procedures.
Before you join a clinical trial, we will give you an informed consent document. It tells you what you must pay for and what the clinical trial pays for.
MSK financial counselors can help you manage any insurance and financial questions about clinical trials.
How do I know if I can join a breast cancer clinical trial?
All clinical trials have guidelines that say who can join, called eligibility criteria.
Many things affect whether you’re able to join a clinical trial. Examples are your age, gender, the type and stage of your disease, past treatments, and other health conditions.
MSK follows eligibility rules to keep you safe. These rules make sure researchers can collect the information they need.
MSK strongly encourages people from all races, genders, ages, and backgrounds to join clinical trials. It’s very important for research studies to include people from many backgrounds.
At what point in my treatment can I join a breast cancer clinical trial? Can I quit any time?
You can look for clinical trials any time during your care. You can even join when you first learn you have cancer.
Please consider joining a clinical trial from the very start of your treatment if there’s one right for you.
For some clinical trials, you must already have tried certain treatments before you’re eligible to join.
Talk with your doctor about whether joining a clinical trial is right for you.
You can leave a clinical trial at any time and for any reason.
Are breast cancer clinical trials safe?
Every clinical trial must be approved and monitored by an Institutional Review Board (IRB). The IRB makes sure the risks are as low as possible and are worth any possible benefits.
MSK’s IRB includes doctors, nurses, community advocates, and others. They make sure the clinical trial follows all federal rules, protects your rights, and keeps you safe.
Once the IRB approves the clinical trial, researchers must follow a careful plan, called a protocol. It describes exactly what will happen during the research study. You will know all the details of the protocol before you join any clinical trial.
Where does MSK offer breast cancer clinical trials?
MSK offers clinical trials, including phase 1 trials, at many of our locations.
We have locations in New York City, New Jersey, Westchester County, and on Long Island.
MSK clinical trials are also offered through our MSK Cancer Alliance partner in Hartford, Connecticut.
We offer clinical trials at these MSK locations:
- Long Island: Commack and Nassau
- New Jersey: Basking Ridge, Bergen, and Monmouth
- Westchester: West Harrison
We encourage people from all races, genders, ages, and backgrounds to join clinical trials. It’s how researchers can learn if a new treatment works for everyone, not just one group of people. Read why Theresa wanted to join cancer research that focused on women of color.