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5 Things You Should Know About Breast Cancer Trials

Posted on August 01, 2012

If you’re thinking breast cancer clinical trials are only for women with metastatic breast cancer, you might be surprised by what you read next. We recently sat down with Elly Cohen, PhD – Program Director of the non-profit organization BreastCancerTrials.org. We were impressed by how muchBreastCancerTrials.org has done to make all clinical trials about breast cancer accessible to women impacted by the disease. We asked Elly if she’d write a guest blog post sharing what every woman dealing with breast cancer should know about clinical trials.

After being diagnosed with early-stage breast cancer in 1998, I had the option of having either a lumpectomy, followed by radiation, or a mastectomy. My mother, who was diagnosed with early-stage breast cancer in 1974, was offered only a mastectomy. The reason I had options was because two landmark clinical trials confirmed that women who have breast-conserving surgery followed by radiation have the same survival rates as women who have a mastectomy.

These studies dramatically changed how breast cancer was treated. But they did even more: they validated clinical trials as the gold standard for comparing one medical treatment to another.

Since that time, doctors have relied on the findings from clinical trials to guide all aspects of breast cancer care, from diagnosis to treatment to survivorship. These include advances in chemotherapy and hormone therapy as well as targeted anti-HER2 therapy, starting with Herceptin® and, most recently Perjeta®, which was recently approved for the treatment of HER2-positive metastatic breast cancer. Some of the latest trials to get underway are evaluating novel biological agents, anti-cancer vaccines, and “smart bombs” equipped with delivery systems aimed specifically at tumor cells. Might one or more of these treatments prevent breast cancer from recurring, make metastatic breast cancer a chronic disease, or eradicate breast cancer all together? Clinical trials will give us the answers.

Advancing breast cancer care through clinical trials requires an ongoing partnership between patients and clinical investigators. Today, there are more than 500 breast cancer trials taking place throughout the U.S. Yet, a relatively small number of patients volunteer for studies. As advocates, it is important that we help educate others in the breast cancer community about the importance of clinical trials. One of the ways we can do this is by dispelling the commonly held myths that are often barriers to participation. In our work at BreastCancerTrials.org, we have found four of the most common myths to be:

    • Myth: Clinical trials are only for people with metastatic breast cancer.
    • Fact: There are treatment trials for breast cancer patients at all stages of disease. Breast cancer trials also look at prevention, screening, and quality of life, including those for post-treatment survivors looking at long-term consequences of cancer and its treatment.
    • Myth: If I take part in a treatment trial, I might be given a placebo (sugar pill).
    • Fact: All patients who join cancer treatment trials receive at least the standard of care. Only in the rare instance that there is no standard of care would patients in a control group receive a placebo.
    • Myth: Any new breast cancer treatment can be studied in a clinical trial.
    • Fact: A new breast cancer treatment is tested in humans only after there is good scientific evidence from laboratory and animal studies that the treatments will be potentially safer or better than the current standard therapy.
  • Myth: Researchers do not treat clinical trial participants well.
  • Fact: Patients in clinical trials are cared for by a team of healthcare providers and are monitored closely during the course of the study. A survey conducted by the Coalition of Cancer Cooperative Groups found that the vast majority of cancer survivors who had taken part in clinical trials were very satisfied with their experience.
  • Myth: If I choose to enter a breast cancer trial, I have to stay in the trial, no matter what.
  • Fact: You can change your mind and stop participating in the trial at any time, for any reason.

As advocates, we should also encourage patients to discuss the availability of trials with their doctor, and if their physician is not supportive, to consider a second opinion. We should also let breast cancer patients know about the resources that are available to find clinical trials they may qualify for. These include the site I have helped develop, BreastCancerTrials.org, which matches users to trials based on their personal health history, as well as the government registries ClinicalTrials.gov (run by the National Library of Medicine) and Cancer.gov (run by the National Cancer Institute). The Love/Avon Army of Women, which alerts members to new studies via email, is another important way for women to learn about breast cancer research.

Clinical trials may not be right for every one. And there might not always be an appropriate trial available at the right time. But as a community of patients and survivors, we can play a significant role in advancing breast cancer care by simplyconsidering trials as a routine option for care throughout our cancer journey, and encouraging others we meet to do so as well.

Elly Cohen, PhD is the Program Director of BreastCancerTrials.org and a breast cancer survivor of 14 years.

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