If your doctor has diagnosed you with breast cancer, you’ll want to know about all of your treatment options. Beyond surgery, chemotherapy, radiation therapy, and other standard therapies, there are promising new ways to treat breast cancer. Researchers carry out clinical trials to study these new treatments, and need people with breast cancer to join them. Clinical trials aren't for everyone, but they can give you more treatment options if you qualify and want to join.
What Is a Clinical Trial?
A clinical trial is a type of study that examines whether a new method for finding, preventing, or treating a disease works well and is safe. There are different types of clinical trials that researchers could use to study breast cancer:
- Natural history studies gather information about how diseases and health change over time.
- Prevention trials look for better ways to stop diseases in people who haven't had them or to prevent them from coming back. These may include medicines, vaccines, or lifestyle changes.
- Screening trials find the best methods to discover diseases or health issues.
- Diagnostic trials work on improving tests and procedures for diagnosing diseases.
- Treatment trials test new medicines, drug combinations, or new surgery and radiation methods.
- Quality-of-life trials, also known as supportive care trials, aim to find ways to help people with long-term illnesses feel better and improve their quality of life.
Many times, researchers will start by testing their ideas in a lab during animal studies. The ideas that show the most potential move to the next stage, clinical trials, where researchers learn more about the pros and cons and how well a treatment works. Researchers carry out clinical trials in phases:
- Phase I. Researchers try out a new drug or treatment in a small group of people for the first time. The goal is to see if it's safe and to find any side effects.
- Phase II. Researchers give the drug or treatment to a larger group of people to see if it works and to judge it further.
- Phase III. Researchers give the drug or treatment to large groups of people to see if it works, check for side effects, compare it to other treatments, and gather information for future use.
- Phase IV. After the FDA approves a drug and it becomes available, researchers watch its safety. They look for more information about the drug's pros and cons, as well as the best way to use it.
Current Clinical Trials and Emerging Therapies for Early Breast Cancer
Current clinical trials for early breast cancer are testing new treatments, especially for high-risk or triple-negative types. They’re also trying to reduce treatment for low-risk patients. Other studies are looking at new drugs, techniques such as T cell therapy, different radiation schedules, and ways to manage side effects.
Treatment and drug trials
- Combination therapies. Studies such as the OFSET trial are testing the addition of chemotherapy to hormonal therapy for premenopausal women with ER-positive/HER2-negative cancer. Other trials, such as the DEBRA trial, compare the typical treatment of radiation and hormone therapy with hormone therapy alone.
- New drug investigations. Clinical trials are testing new drugs, such as camizestrant in the CAMBRIA-2 trial and enzalutamide.
- Cellular therapies. Researchers are using cellular therapies, such as tumor-infiltrating lymphocytes (TILs), to treat solid tumors, including breast cancer. Another study is testing engineered T cells to fight cancer.
Reducing and improving treatment
- Reducing radiation. The PROSPECT trial is studying whether women with low-risk early breast cancer can safely skip radiation treatment after surgery by using extra imaging.
- Shorter radiation courses. The FAST-Forward trial compared a one-week radiation treatment to the standard three-week treatment to find out if the shorter course worked as well.
- Hormonal therapy trials. Some trials are looking at new ways to use hormonal therapy, including lower doses of tamoxifen in the LoTam trial.
Trials for subtypes of breast cancer
- Triple-negative breast cancer. Scientists are studying whether people with early-stage triple-negative breast cancer who responded completely to treatment before surgery still need more treatment afterward. The study aims to find out if just watching them works as well as continuing the usual treatment (pembrolizumab) in preventing the cancer from returning.
- HER2-positive breast cancer. The ATEMPT 2.0 trial is studying how well early-stage HER2-positive breast cancer responds to different combination therapies (trastuzumab-emtansine, trastuzumab SC, paclitaxel) post-surgery.
- Hormone receptor-positive, HER2-negative breast cancer. The lidERA trial is looking at how well a new medicine, giredestrant, works compared to standard hormone therapy for people diagnosed with early-stage, estrogen receptor-positive, HER2-negative breast cancer.
Managing side effects
- Aromatase inhibitor pain. The Online Program for Aromatase Inhibitor Pain Trial is designed to see if an online program can help people living with early-stage breast cancer better manage bone, joint, and muscle pain from aromatase inhibitors, a type of hormone therapy for cancer.
Who Is a Good Fit for a Breast Cancer Clinical Trial?
To join a clinical trial, you’ll first need to meet certain requirements. The study researchers will want to know:
- The type of cancer you have
- The stage of your condition
- Your age and gender
- Other treatments you’ve had
- Other long-term health conditions you live with
- If you’re pregnant or plan to become pregnant
- How well your liver and kidneys work
- Medicines you take
- Your overall health
It’s crucial that you’re up-front with the study team about your medical history so they can try to avoid negative impacts of the treatment. They should also let you know about any possible side effects, so you have all of the facts before deciding whether to join.
Diversity in clinical trials
Another important part of clinical trials is making sure the participants represent the general population and the people who will likely use the treatment. In the U.S., racial and ethnic minorities and older adults may be underrepresented in clinical trials. Including more of these groups in clinical studies could help develop better treatments and improve health outcomes for everyone.
Pros and cons of joining a clinical trial
All medical treatments have potential benefits and drawbacks, and clinical trials are no exception. Taking part allows you to be more involved in your own health care and may give you access to new treatments before they’re available to the public. During the study, doctors will provide care and closely watch your progress. By joining, you’re also helping advance medical research, which can benefit other patients now and in the future.
There are also some risks to consider when joining a clinical trial. You might have unpleasant, serious, or even life-threatening side effects. Taking part could mean more doctor visits, treatment sessions, or hospital stays than with standard care, and the trial treatment may not work as well as traditional options. Also, taking part in a clinical trial is voluntary, and you can stop at any time and for any reason.
How to Join a Breast Cancer Clinical Trial
To join a clinical trial for breast cancer, first talk to your doctor. They’ll know if one is happening and whether you’re a good fit. You’ll then complete the informed consent process to make sure you understand the details of the study before you officially sign an agreement. That’s followed by a screening to confirm you’re eligible for the study.
Questions for Your Doctor About Clinical Trials and Emerging Therapies
You likely have many questions about clinical trials and other emerging therapies. To remember everything you want to ask, make a list of questions. Think about asking a friend or family member to join you for appointments to help take notes and remember what the doctor or researchers said. Here are some questions you can ask:
- What is the goal of the study?
- What phase is this study?
- Who will take part in the study?
- Have you tested this treatment before?
- Why do you think the treatment will work?
- What tests and treatments will I need?
- What are the potential risks, side effects, and benefits, and how do they compare to the treatment I’m using now?
- How could the trial impact my day-to-day life?
- How long could the trial last?
- Will I need to stay in the hospital during the trial?
- How often will I need to go to the hospital for treatment?
- Who will pay for the treatment?
- Will you pay me back for out-of-pocket expenses?
- Will I need follow-up care?
- Will I know whether the treatment is working?
- Will I receive the trial results?
- Who will be responsible for my care?
- Who do I contact with questions about the trial?
Show Sources
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SOURCES:
Stanford Medicine: “About Clinical Trials.”
Memorial Sloan Kettering Cancer Center: “Questions to Ask Your Doctor About Clinical Trials,” “How to Join a Clinical Trial,” “A Phase III Study Comparing the Usual Treatment of Radiation Therapy and Hormonal Therapy versus Hormonal Therapy Alone for the Treatment of Low-Risk, Early-Stage Breast Cancer.”
Mount Sinai: “How to Join a Clinical Trial.”
National Cancer Institute: “Steps to Find a Clinical Trial.”
Moffitt Cancer Center: “Am I A Candidate for a Clinical Trial?”
Breastcancer.org: “Featured Clinical Trials for Breast Cancer,” “OFSET Clinical Trial for Early-Stage Breast Cancer.”
Clinicaltrials.gov: “ATEMPT 2.0: Adjuvant T-DM1 vs TH.”
Lancet: “Postoperative radiotherapy omission in selected patients with early breast cancer following preoperative breast MRI (PROSPECT): primary results of a prospective two-arm study.”
Radiotherapy & Oncology: “Patient- and clinician-assessed five-year normal tissue effects following one-week versus three-week axillary radiotherapy for breast cancer: Results from the phase III FAST-Forward trial randomised nodal sub-study.”
Yale School of Medicine: “LoTam: A Randomized, Phase III Clinical Trial of Low-Dose Tamoxifen for Selected Patients With Molecular Low-Risk Early-Stage Breast Cancer.”
Cancer Research UK: “Research into treatment for early breast cancer.”
Contemporary Clinical Trials: “Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change.”
Pfizer: “How to Participate in a Clinical Trial.”
