What is a basket clinical trial for cancer and how is it different from traditional cancer trials?
Historically, cancer trials have been designed to prove drug safety and effectiveness for a particular tumor type. In these trials, response to the treatment can vary greatly, even though all of the patients have the same type and stage of cancer, and it was unknown why certain patients responded better than others.
The advent of Next-Generation Sequencing (NGS), also called molecular profiling of tumors, has allowed researchers to discover that tumors with a specific mutation(s) have the potential to respond to a treatment targeted to that mutation. We now know that there are more than 200 separate types and subtypes of cancer and although categorized the same, one person’s lung adenocarcinoma can be much different genetically and molecularly than another’s.
This discovery has led to a new designs of trials, so that genetic alterations that drive tumor formation and growth can be more specifically targeted.
We now know that there are more than 200 separate types and subtypes of cancer
Basket clinical trials have emerged as a key new trial design and are named this because the focus is on a defined tumor mutation (or mutations) instead of a tumor type. Patients who all have a specific tumor mutation, but with varying tumor types, are enrolled into the study and put into individual study arms, or “baskets” by tumor type. For instance, a solid tumor basket trial would look to enroll a number of subjects that could include breast, ovarian, lung, brain, colorectal, gastric, among others and each tumor type would be in its own arm or basket. Investigators would evaluate each arm to determine the rate of response, as well as across all arms in that trial. These types of studies are often for newly defined or rare tumor mutations, where finding a large enough population in one tumor type with that specific mutation, would be very difficult and lengthy.
Current Basket Clinical Trial Cancer Research
The NCI (National Cancer Institute) is currently enrolling 2 large basket studies, the Molecular Analysis for Therapy Choice (MATCH) trial, which will match 1000 solid and lymphoma patients with specific tumor mutations to targeted therapies, in addition to the Molecular Profiling-Based Assignment of Cancer Therapy (MPACT) trial where patients with a particular mutation are randomly assigned to a targeted therapy or non-targeted therapy. Learn more from the American Society of Clinical Oncology
Pharmaceutical and biotechnology trial sponsors are also utilizing the basket clinical trial study design and are currently running trials enrolling patients with various solid tumors and one or more defined tumor mutations.
As investigators learn from these studies and NGS testing becomes more available and affordable we will have increasingly more tumor mutation data, and will advance our understanding of the role tumor mutations play in precision medicine. The hope is that cancer patients will have new targeted therapies that will have a significant impact on cancer care.
Pharmaceutical and biotechnology trial sponsors are also utilizing the basket study design and are currently running trials enrolling patients with various solid tumors and one or more defined tumor mutations
Why Cure Forward?
Whether you’re seeking information about basket clinical trials for cancer or studies related to some other form of cancer, it can be hard to find trials that might be a good match.
Through our Clinical Trial Exchange, Cure Forward collects data on clinical trials and studies from multiple sources making it easier to find all the options that are available for you or your loved one. We work directly with clinical trial recruiters to help introduce their trials to potential candidates.
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