Breast Cancer Treatment Emerges from Clinical Trial: A Case Study

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We are at an exciting time in the history of cancer treatments. Over the past decade, the diligent work of doctors and scientists, along with thousands of patients who participate in clinical trials, have unlocked cancer pathways leading to important discoveries in treating a variety of cancers.

What is a Clinical Trial?

Basically, clinical trials try to find out if a new medication or treatment is better than what is already available, and what the side effects might be. Sometimes it's important to learn if no treatment is better than any.

Why Participate? A Story Close to Home

Several years ago, one of my patients who had breast cancer that had spread to her bones (metastatic breast cancer), decided to enroll in a clinical trial at Harvard Medical Center. The study was testing a new drug in combination with the existing standard treatment—an anti-hormonal therapy (a drug called femara or letrozole)—for treating advanced metastatic breast cancer.

The treatments worked exceeding well and the large tumor in her breast completely disappeared, and multiple tumors in her bones shrank.

Given the promising results, the FDA approved the drug (palbociclib) for use in combination with anti-hormonal therapy. Women taking the combination lived at least 10 months longer than those on letrozole alone.

There are many similar recent success stories.

Who Should Participate?

Having patients willing to take part in clinical trials is at the heart of research that advances cancer care and the search for a cure. A discussion with your doctor is essential in helping you make the decision to participate, as there are many factors to consider.

Here are some answers to questions patients frequently ask:

Q: Is it true that I might get a “sugar pill” and not active or effective treatment?

A: Although some clinical trial may have a “sugar pill” or placebo, most don’t, and this is always clearly described. While it is possible the experimental drug may turn out to be less effective than standard treatment, in most trials the experimental drug is given in combination with standard treatment, making this less likely.

Q: Can I stop once I start treatments?

A: Patients have the right to withdraw from clinical trials anytime for any reason.

Q: Could the experimental drug be unsafe?

A: The new drug has been through two phases of testing before entering the third phase where it is compared to an approved drug or treatment. Safety is paramount in any clinical trial, although not all side effects may be known or anticipated. At the first sign of any serious side effects, treatments are stopped. Clinical trials are carefully monitored by regulatory agencies.

Q: Should I participate in a clinical trial only after exhausting all available treatments?

A: Although this is true for many cancers with established treatments and robust benefits, it is always helpful to enroll in clinical trials early when feeling well, especially if the cancer has limited standard treatment options.

Q: Will my insurance cover clinical trials?

A: While it can be a challenge to get approval with some insurance companies, most do cover clinical trials. Knowledgeable support staff works through the details with patients planning to enroll.

The Ann B. Barshinger Cancer Institute has several clinical trials open for a variety of cancers. Our partnership with the University of Pennsylvania Health System is providing access to many more cancer trials. We can also help patients find clinical trials throughout the country and even worldwide.

Only with continued research can we make progress in our fight against cancer, and for that, we need the support of everyone involved—our professionals, our medical institutions, and above all, our patients.

author name

Shyam S. Balepur, MD

Shyam S. Balepur, MD, is a medical oncologist and hematologist at Lancaster General Health Hematology & Medical Oncology. Dr. Balepur’s areas of expertise include cancers of the blood, brain, and digestive system.

Education: Medical School–Osmania Medical College, India; Residency–University of Virginia; Fellowship–Georgetown University Hospital, Washington, DC.

Call: 717-544-9400

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