Understanding Clinical Trials for Advanced Breast Cancer

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We have come a long way with available treatments for advanced breast cancer, but researchers are continuously striving for improved outcomes. Every new medication, procedure, or device developed for treating breast cancer must first undergo rigorous clinical trials to test its safety and effectiveness before it can become a standard treatment. In fact, clinical trials are absolutely necessary to make any advances in medicine. But according to the American Cancer Society, less than 5% of adults with cancer actually participate in clinical trials, posing quite a challenge for researchers. Is this due to lack of knowledge about clinical trials? Not knowing where to find them? Fear of participation? Let’s shed some light on clinical trials and hopefully pave the way for continued breast cancer research.

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Why are clinical trials important for advanced breast cancer?

Advanced breast cancer refers to Stage IV, or metastatic breast cancer, which is cancer that has spread to other parts of the body. Though treatable, there is currently no cure. Additionally, between 20 and 30% of patients with early stage breast cancer will eventually become metastatic. If we ever want to learn how to put an end to advanced breast cancer or prevent early stage cancer from spreading or recurring, clinical trials are needed to find the answers.  

How do breast cancer clinical trials work?

There are different stages, or phases, that take place when investigating a new breast cancer treatment. After a treatment has been carefully studied in a lab, clinical trials may begin.  

  • Phase 1 trials help determine if a treatment is safe for human use. A small group of volunteer participants are carefully monitored for side effects and different drug dosages may be tested. At this level, establishing treatment safety is more important than evaluating its effect on breast cancer.

  • Phase 2 trials will look to see if the treatment actually works against breast cancer using the dose or method that has been established in phase 1. If the treatment appears to work, it will move on to the next phase.

  • Phase 3 trials examine if the new treatment is better than what is currently being used. Participants in phase 3 trials will be randomly selected to get the new treatment versus the standard treatment. If the new treatment is found to be safer or more effective, it may be submitted to the Food and Drug Administration (FDA) for approval.

  • Phase 4 trials continue to monitor and study the effects of the new FDA-approved treatment over the long-term.

What clinical trials are available for advanced breast cancer?

Participation in clinical trials may be low because many breast cancer patients simply don’t know what options are available. If you are interested in volunteering for a trial, talk to your doctor. Each study will have a specific set of criteria you must meet to be eligible, such as your stage of breast cancer or previous treatments, and your doctor can help guide you in the right direction.

There are also clinical trial lists you can search online:

What should be considered before enrolling in a breast cancer trial?

If you are eligible for a clinical trial, there are several things you should discuss with your doctor and/or the research coordinator for the study. This includes:

  • The purpose of the study

  • Risks versus benefits of participation

  • What is required from you? How long will you be in the study? Do you have to travel to receive treatment? How often do you need to be seen?

  • How are medical expenses covered? What is paid for through the study versus your insurance or out of pocket?

  • Who you can contact with any questions or concerns?

It’s important to think about your motivation for joining a trial as well. Are you hoping for the chance to receive a cutting-edge treatment that is not available otherwise? Are you simply happy to be contributing to breast cancer research and looking to help others in the future? Being honest with yourself will help ensure that you’re making the right decision on whether or not to participate.

Remember also that taking part in a trial is voluntary. You reserve the right to opt out at any time if you change your mind.

What is the biggest misconception about participating in clinical trials?

Many patients are hesitant to participate in a clinical trial because they fear they are taking a chance at receiving a placebo, or inactive form of treatment. However, it is unethical to put a patient at risk if there is an effective form of treatment available. Patients with advanced breast cancer who enroll in a clinical trial will either be given the standard line of treatment or the treatment that is being studied. A true placebo, where the patient essentially receives no treatment, can only be used when there is no known treatment for a particular condition.

What types of breast cancer treatment have resulted from clinical trials?

Some of biggest discoveries in breast cancer treatment have been the development of hormone therapy, like Tamoxifen, and anti-HER2 therapy, such as Trastuzumab (Herceptin). Once researchers were able to identify specific proteins on the surface of some breast cancer cells that allowed them to grow, clinical trials were used to develop drugs to block these proteins and stop the cancer from growing.

Looking into the future, clinical trials are studying how to use the body’s immune system to fight advanced breast cancer and stop recurrences. This type of treatment, known as immunotherapy, has been effective for other forms of cancer such as melanoma, but researchers are hopeful that further studies will lead to breakthroughs in treating breast cancer as well.

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Medical Reviewer: William C. Lloyd III, MD, FACS
Last Review Date: 2019 Jul 20

  1. Breast Cancer: About Clinical Trials. American Society of Clinical Oncology. http://www.cancer.net/cancer-types/breast-cancer/about-clinical-trials

  2. Clinical Trials. Susan G. Komen. http://ww5.komen.org/BreastCancer/ClinicalTrials.html

  3. Immunotherapy for High-Risk or Metastatic Breast Cancer. The University of Texas MD Anderson Cancer Center. https://www.mdanderson.org/publications/oncolog/july-2015/immunotherapy-trials-offer-hope-to-patient...

  4. NIH Clinical Research Trials and You. National Institutes of Health. https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics

  5. The Basics of Clinical Trials. American Cancer Society. https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/c...

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