By Dr. Kathleen Ruddy

Clinical trials of investigational drugs require two groups of volunteers, one to receive the new drug and one to receive standard treatment. Comparing results between both groups determines the efficacy of the drug. Newly designed basket studies will provide similar information more quickly.

How are traditional clinical trials designed to test the efficacy of a new cancer drug?

Traditionally, a new (i.e., investigational) cancer drug must be tested in two groups of volunteers. One group receives the new drug while the other group receives standard treatment. If both groups of volunteers are equally matched for variables like age, extent of disease, prior exposure to other treatments, then any differences in the outcome (e.g., progression of disease or survival) can be attributed to the new drug. Side effects of the new drug can also be revealed by comparing both groups of volunteers. If the volunteers do not know whether they are receiving the new drug or standard treatment, the trial is said to be “blinded”. If the investigators who are conducting the trial are also not aware of which volunteer is receiving the new drug or standard treatment, then the trial is said to be “double-blinded”.

What are the drawbacks of traditional clinical trials for investigational cancer drugs?

Traditionally, clinical trials can take as long as ten years before it is known if a new drug is safe and effective in treating a particular cancer. Additionally, patients who enroll in traditional clinical trials hope to have a chance of benefitting from a new drug, but they may end up being part of the group of volunteers that receives standard treatment, and, so, have no chance of enjoying the potential benefit that might come from the new drug.

What are basket studies?

Basket studies are an entirely new way of investigating the potential benefits of new cancer drugs. Because scientists can now identify dozens of cancer mutations based on improved technology in gene sequencing of tumors, drug makers are able to develop agents that effectively block these mutations. Some of these new mutation-blocking drugs have proven extremely powerful in prolonging survival in patients with aggressive and advanced cancer.

Basket studies are designed to enroll cancer patients into a clinical trial based on the kind of mutations found in their tumors, regardless of the origin of the tumor. Patients with melanoma, lung cancer, breast cancer, and brain cancer might have tumors that all share a similar genetic mutation and, therefore, may benefit from a drug that blocks that mutation. Instead of conducting traditional clinical trials composed of patients who share the same tumor, basket studies are designed to study cancer patients whose tumors share the same mutation.

What are the advantages of basket studies compared to traditional clinical trials?

Basket studies move much faster and require very few patients, relatively speaking (e.g., less than 50 compared to thousands of volunteers.) Because patients with similar mutations are grouped together in a single ‘basket’, the need to duplicate the trial for each and every type of cancer is alleviated. As importantly, every volunteer in a basket study receives the new drug – every volunteer is given a shot at the chance for an improved outcome.

When will basket studies get underway?

Memorial Sloan-Kettering Cancer Center and other major cancer research centers in the country have begun conducting basket studies. A large national program called Match that will involve thousands of patients whose tumors will be screened for similar genetic mutations will begin this year.

 

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