Basket Clinical Trials
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 treatment can vary greatly, even though all of the patients have the same type and stage of cancer. Previously researchers faced the challenge of not knowing 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 modifications in clinical trial design, so that genetic alterations that drive tumor formation and growth can be more specifically targeted.
There are more than 100 separate types and sub-types of cancer.
Basket clinical trials, which are designed to focus on a defined tumor mutation (or mutations) instead of a tumor type, have emerged as a key new trial design. 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, recruiters for a solid tumor basket trial would look to enroll subjects with a similar mutation profile, but different types of cancer. This trial could include patients with breast, ovarian, lung, brain, colorectal, gastric, or other types of cancer, and each tumor type would be in its own arm or basket. Investigators would evaluate each arm to determine the rate of response, in addition to determining the overall response rate 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 a very difficult and lengthy process.
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-tumor and lymphoma patients with specific tumor mutations to targeted therapies and 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 recruiting for trials to study patients with various solid tumors and one or more defined tumor mutation.
As investigators learn from these studies and NGS testing becomes more available and affordable, the repository of tumor mutation data will grow, advancing our understanding of the role tumor mutations play in precision medicine. The hope is that these advances will lead to 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.
When you get started with Cure Forward, your personal Clinical Trial Navigator with help you and you care team build a robust profile inclusive of your full medical history, personal preferences and molecular profile (when applicable), all at no cost. We are able to provide this free service as we focus on building robust profiles so we can match patients with relevant and active clinical trial options, opening the door to advanced treatments and accelerating medical innovation. We work directly with clinical trial recruiters to help introduce their trials to potential candidates.
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