How to Apply to a Breast Cancer Clinical Trial

Breast cancer survival rates have improved significantly in the past 30 years, thanks to advancements in how the disease is diagnosed and treated. Clinical trials are one of the key reasons more women are surviving breast cancer than ever. 

Breast cancer clinical trials are research studies that test the effectiveness and safety of new ways to detect, treat, and improve a person's quality of life for all types and stages of breast cancer. Every treatment currently available underwent testing in clinical trials before getting approval from the U.S. Food and Drug Administration (FDA). These trials allow people with breast cancer to try new approaches and treatment methods. 

This article covers how to find and enroll in breast cancer clinical trials, what to expect, and research advancements achieved thanks to these vitally important studies. 

Benefits of Clinical Trial Participation

New breast cancer treatments undergo extensive testing in research labs and animal studies before undergoing testing in clinical trials with human volunteers. Clinical trial participants help researchers understand how a new treatment works and determine if it is more effective than current treatments. 

Several benefits to participating in a clinical trial include:

• Accessing promising new therapies
• Contributing to research discoveries
• Close monitoring by a team of healthcare providers
• Lower costs
• Taking an active role in your care

For some with breast cancer, a clinical trial may be the best treatment option available and offer hope for improved outcomes.

Possible Risks 

There are potential risks and drawbacks to participating in a clinical trial, such as: 

• A lack of treatment choice (e.g., the randomized possibility of receiving standard or no intervention or a placebo, rather than the treatment under investigation)
• Unexpected side effects
• Healthcare and travel costs
• Time commitment due to more frequent medical appointments and testing

Breast Cancer Research Advancements

Researchers worldwide are working to find safe and effective methods for preventing, detecting, diagnosing, and treating breast cancer. Breakthroughs in research advance our understanding of how metastatic breast cancers develop and spread in the body and lead to more effective, targeted therapies.

Clinical trials play a critical role in developing new standards of care and treatment breakthroughs for people with breast cancer. Recent discoveries have significantly improved survival rates and quality of life for people with breast cancer.

Qualifications

Every clinical trial has eligibility criteria—requirements you must meet to participate in the trial. These requirements help researchers ensure study results are as accurate as possible and cannot be attributed to other factors beyond the tested treatment. 

Eligibility criteria vary from study to study, though certain requirements for specific groups of people may include:

• Type and/or stage of breast cancer
• Treatment history
• Specific genetic markers in tumors
• Other medical conditions

Medical Documentation

Before joining a clinical trial, the research team will ask you to share your detailed medical history. This should include information about your breast cancer diagnosis, pathology report, tumor testing, imaging scan results, past treatments, and medications you’re currently taking.

This information helps investigators determine if you meet the eligibility criteria or have characteristics (exclusion criteria) that would prevent you from joining the study. 

Location 

Breast cancer clinical trials occur in hospitals, clinics, medical centers, and cancer centers throughout the U.S. and worldwide. Some trials take place in one location, while others take place across several sites. 

You may find a clinical trial you are eligible for in your area, but other trials may require you to travel. If you meet the eligibility criteria for a clinical trial that is far from home, you may have to pay out of pocket for your travel-related expenses, including transportation, lodging, and food.

Clinical Trial Finder 

Talk with your healthcare provider if you’re interested in joining a clinical trial. They can discuss whether it’s a good option and help you find clinical trials you may be eligible for in your area.

Online clinical trial databases allow you to search for publicly and privately funded trials recruiting participants. You can search for clinical trials based on your breast cancer type, stage, and location. Breast cancer clinical trial databases include:

• ClinicalTrials.gov
• National Cancer Institute
• BreastCancerTrials.org
• Lazarex Cancer Foundation
• CenterWatch
• EmergingMed

How to Enroll in a Breast Cancer Clinical Trial 

If you find a clinical trial you’re interested in joining, the first step is for you or your healthcare provider to contact the study’s research coordinator. You can usually find contact information for the research team in the study description. 

Pre-Enrollment

Before enrolling in a clinical trial, you will attend a screening appointment. During this visit, the research team will provide you with details of the study and review your medical history to determine your eligibility.

The research team goes through the informed consent process with you, reviewing details of the study, including:

• What to expect 
• What treatment is undergoing testing
• Potential risks and benefits 
• Required tests or procedures
• Your out-of-pocket costs for the trial (if any) 
• Alternative treatments if you choose not to participate

This is a good time to ask any questions about the trial. Taking notes during this appointment and bringing along a family member or friend for support can will also likely prove beneficial.

If you choose to join the study, your healthcare provider will ask you to sign a consent form that outlines the study details. You can review this with them before signing it. 

During the Clinical Study 

After signing the consent form, you may need imaging or blood tests to confirm your eligibility and ensure your safety throughout the trial. When the trial begins, the new treatment will be administered on a schedule similar to that of standard therapies.

Most clinical trials closely monitor participants, which may mean more frequent appointments and tests to determine how the treatment is working and how your body is responding. The research team will want to know if you are experiencing any side effects or new symptoms, so be sure to communicate how you feel throughout the study.

If at any point you decide you no longer want to participate in the study, you can leave it at any time, for any reason.

Debriefing

A debriefing occurs when your participation in the clinical trial is complete. During debriefing, you have the opportunity to discuss the trial's details with the research team, ask questions, and share any additional experiences related to the clinical trial. You will receive and/or read a debriefing statement that generally includes:

• The goals of the study
• A full explanation of the treatment that was tested
• The results of the study (if available) or information on how you will be informed of the results when available 
• Information about additional research and/or support services 
• Researchers' contact information 
• A thank you for your participation

Costs and Affordability 

Before you decide to join a clinical trial, it’s important to understand your out-of-pocket costs. For most clinical trials, the study sponsor covers the cost of the new treatment and any additional lab tests and imaging scans performed for the purposes of the study.

Health insurance often covers costs related to treating breast cancer, including visits with your healthcare provider, hospital stays, standard cancer treatments, and medications prescribed to reduce cancer symptoms and side effects from treatment. 

When you participate in a clinical trial, you can anticipate extra medical appointments so your healthcare provider and researchers can carefully monitor your progress. In some cases, the study sponsor covers the cost of these additional appointments, but not always. If you travel to participate in a trial, you may also have additional transportation, lodging, food, and child care expenses. 

Summary

Advancements in preventing and treating breast cancer are often possible because of clinical trials. For some, participation in clinical trials is the best treatment option. If you are interested in participating in a clinical trial, speak to your healthcare provider to learn about the benefits and risks and whether you are eligible.

The benefits of participating in a clinical trial include access to new therapies, close monitoring, and the ability to contribute to research. Some potential risks include unexpected side effects, a lack of treatment options, and increased cost and travel time. Choosing to join a clinical research trial for breast cancer treatment is a big decision that you should discuss with your healthcare provider.

A Word From Verywell 

Choosing to join a clinical trial is a big decision. Before you decide, ensure you have all the information you need to make an informed decision and are aware of the potential benefits and risks. You may want to talk to your healthcare provider about your options or find support and guidance in online or in-person breast cancer support groups.