Basket of Baskets trials

Traditional anticancer treatments, like chemotherapy or other drugs, are aimed at treating forms of cancer that affect a specific organ, such as lung, breast, ovary, skin or other organs. They are also used to treat other forms of cancer affecting the blood, the bone marrow, or the lymph nodes, such as leukemia, myeloma, lymphoma, etc). Clinical trials designed to evaluate the efficacy of anticancer drugs involve the participation of patients with the same cancer type, irrespective of the genetic mutations they carry, since these drugs are not mutation-specific. “Target therapies” are newly developed therapies aimed at blocking a specific mutation which characterizes a form of cancer regardless of its site.
“Basket trials” are a new type of clinical studies focused on the treatment of cancer patients carrying a specific mutation (Genes and their mutations), in whom cancer location or type may be different. These patients are treated with the same experimental drug that is supposed to block that mutation. The objective of a Basket trial is to evaluate a single targeted therapy in the context of multiple diseases or disease subtypes. For this reason, Basket trials often adopt a methodological approach called “single-arm” which involves the evaluation of the efficacy of a drug without using a comparator. They are also called “histology agnostic”, as they include cancers with a different histology.
Basket trials can become more complex. For instance:

• Patients within each basket are randomly allocated to a control or to an experimental treatment (randomized Basket trial).
• Multipledrugs are evaluated across a selected number of genetic mutations and cancer locations.

If you have been invited to participate in a Basket of Baskets trial by your treating clinician, there are a few important things you need to know:

• This is a study in which several Basket trials are conducted. It also implies that multiple drugs are evaluated across a selected number of genetic mutations (Genes and their mutations) and cancer locations.
• Your participation in a particular Basket trial is determined by the particular mutation you are carrying.
• All the patients participating in a Basket trial carry the same mutation as yours and will be treated with the same target therapy.

This Basket of Baskets trial has been approved by the Ethics Committee (Clinical trial) and the centers involved in these studies are part of a network of European clinical hospitals specialized in this field. 

The Basket of Baskets trial is composed of two parts:

• Part A (i-Profiler) is the preparatory phase of the study, in which the tissue of your cancer is
  analyzed to find out if it carries any mutations that could be a target for the specific target-
  drug therapy. This will be performed through a laboratory test.
• Part B (i-Basket) is the clinical trial part, in which patients with the same kind of mutation are
  treated with the appropriate target drug. If the i-Profiler phase establishes that you are
  carrying one of the mutations of interest, you will be offered the possibility to be included in
  the Basket trial specific for the mutation (Genes and their mutations) you are
  carrying. 

If your treating clinician establishes you are potentially eligible for the Basket of Baskets trial, you will be asked to read an information sheet and to sign a consent form in order to participate in part A (i-Profiler). (Informed consent) 

If the mutation test shows you are eligible to be included in Part B (iBasket), you will be provided with an additional information sheet and consent form to take part in the clinical trial (Informed consent).