Clinical Trials for Breast Cancer Treatment: A Step-by-Step Guide

Quick summary

Chances are, as you explore breast cancer treatments, someone will mention the possibility of joining a clinical trial. Your oncologist may recommend it, if she knows of one that might be appropriate, or family and friends who've battled cancer may suggest joining a trial. Trials are often worth considering when an oncologist doesn't think the standard treatments have a promising outcome -- or when you or the person in your care could participate while getting other treatment. But how do you find a trial that's right for you and your family, and what's involved in getting into one? Here's a step-by-step plan to take you through the process.

Gather the data you'll need for your search.

The oncologist you're seeing may know of and recommend a particular trial, but often this isn't the case. (And just because she doesn't recommend a trial doesn't mean there isn't a great one out there that's a good match.) Hundreds and hundreds of clinical trials are going on across the country at any given time, and oncologists can't keep up with all of them.

To find appropriate clinical trials, you'll be searching research databases, and you'll need certain information to do so. Start by collecting as much specific data about the diagnosis and prognosis as you can. Clinical trials are often limited to patients with a particular type of cancer, at a particular stage, that has been classified a certain way (operable versus inoperable, for example), so you'll need to know all that to begin your search. You'll also need the treatment history and details of other medical conditions for you or the person in your care, so keep those medical records nearby while you research.

One thing that's essential to consider: Some trials won't accept patients who've already received other treatment, such as radiation or chemotherapy. This means you'll have the most options if you consider a clinical trial early on. Later on, your choices will be limited to trials aimed at patients who've already tried a particular therapy. If, initially, your doctor recommends a course of treatment but lets you know that it has a limited chance of success, that's the time to begin searching for a clinical trial that might offer treatment with a better possible outcome. If, on the other hand, the oncologist thinks there's a good chance of survival with immediate chemo or another such treatment, it may not be advisable to go with a clinical trial.

Familiarize yourself with the clinical trials database.

The national database of all ongoing clinical trials, maintained by the National Institutes of Health, is the place to start your research. Another database , maintained by the National Cancer Institute, allows you to search by zip code (or by a specified number of miles from any given zip code), which is useful if travel for the trials isn't an option. Keep in mind, though, that it could be worth traveling if the right trial is only available elsewhere.

You can search these databases by condition (such as breast cancer ), by the name of a particular drug being tested, by sponsor, or by location. You can also customize your search by typing in a string of terms, such as inflammatory breast cancer, stage IV.

Make your search as specific as possible.

For a clinical trial to yield useful results, researchers usually must restrict the patients who participate, so certain factors won't throw off the conclusions. To do this, they set up specific eligibility criteria, often called inclusion criteria and exclusion criteria. For example, inclusion criteria for the trial of a new chemo agent might specify that the trial is recruiting patients who've already undergone a mastectomy -- or the opposite may be true; researchers may want only patients who haven't yet undergone surgery.

Many times, some criteria will be indicated in the name of the trial itself, but it's best to read through the study methodology to see if it's a good fit. Researchers may exclude for age, gender, use of other medications, or complicating health conditions.

Try to narrow your search using any information you have about the specifics of your breast cancer. Details that can narrow your search include whether the breast cancer is metastatic (meaning it has spread beyond the original area) or recurrent, the type of tumor involved, and any drug or therapy regimen used. So, for example, a clinical trial for breast cancer might specify that it's only for patients who've undergone a modified radical mastectomy for a tumor that's estrogen receptor-positive and has not yet been treated with radiation.

Analyze the clinical trials available by phase.

The testing process for new drugs and treatments is rigorous, requiring multiple steps so that researchers have plenty of chances to monitor risks and spot side effects. Drugs and treatments undergoing testing usually go through four phases:

Phase I: Used to research how to set up larger trials. A phase I trial is usually very small, requiring just a few volunteers, and focuses on basic safety and efficacy, as well as how to administer the drug and the best dose to test.

Phase II: Organized to systematically test safety and effectiveness.

Phase III: Set up to compare safety and effectiveness against existing drugs and treatments, phase III trials are very large, usually with thousands of participants. They're held at multiple locations, participants are randomly assigned to receive either the new treatment or standard treatment, and processing all the data usually requires several years. The majority of trials breast cancer patients enter are phase III trials.

Phase IV: This involves a follow-up study, usually conducted after the drug or treatment receives FDA approval, focusing on monitoring long-term safety and efficacy.

A drug that's in a phase III trial has been tested on more patients and subjected to more scrutiny for possible side effects than a drug in a phase I or II trial, so it's usually best to opt for the latest phase available.

Make the call.

Once you have a short list of trials that sound promising, you'll need to contact the research team for each trial. Usually a research nurse or investigator in charge of screening for the trial will have the initial conversation with you. This is also a chance for you to ask basic questions about the trial. These might include:

  • Why do the researchers think the approach being tested may be effective?
  • Has this drug or treatment been tested in other trials?
  • Who's sponsoring, reviewing, and approving the study -- for instance, is it sponsored by the National Cancer Institute or a drug company?
  • What are the credentials and experience of the research team?
  • What procedures are in place for monitoring the safety of the study participants?
  • How long will the study last?

In turn, the research nurse will ask you questions to determine if you or the person in your care is a good candidate for the trial. Have medical records handy, as she may ask you to provide specific information, such as the names of drugs taken or the most recent platelet or red or white blood cell count . If the research team determines from your answers that things look promising, the trial manager will then set up an appointment for the official screening. If the trial is nearby, this screening may take place in person; if not, it's sometimes possible to do the initial screening over the phone after providing the necessary records via mail or e-mail.