What Are Master Protocols?

Master protocols are clinical trials that are specifically designed to allow researchers to study several molecular markers and targeted therapies simultaneously. These protocols also allow researchers to introduce new therapies into a trial that is already underway.

Researchers are still learning the best way to design these protocols and choose the proper statistical methods for evaluating their findings. Here you can read about how master protocols are being used in breast cancer and other clinical trials.

Want to learn more? The February issue of MTT discussed two types of master protocols: basket trials and umbrella trials.

All about Basket and Umbrella Trials

Basket trials and umbrella trials were created to help researchers study how tumors respond to targeted therapies.

Basket trials, also known as bucket trials, enroll patients whose tumors have a specific genetic mutation, regardless of where their cancer started.

Umbrella trials enroll patients with one type of cancer and have many different treatment arms. Patients are assigned to a specific arm based on the biomarkers seen in their tumor.

The articles below explain the goals of these trials. They also discuss potential challenges and concerns.

You can find all the basket trials enrolling breast cancer patients from BreastCancerTrials.org

Understand Basket and Umbrella Trials

Basket and Umbrella Trials: Past and Now

Basket Trials: Advantages, Challenges and Opportunities

Current Basket Trials:

The Lack of Diversity in Clinical Trials

The lack of diversity in clinical trials continues to draw attention and concern.

Below you will find a recent analysis by journalists that found African Americans and Native Americans are under-represented in clinical trials of new drugs in the U.S., even for types of cancers that disproportionately affects them. There is also an article that looks at the global nature of this problem. 

Perspectives on Clinical Trials

Entering a clinical trial may be an option for many women and men with metastatic breast cancer. As you decide whether to enter a trial, you may want to hear multiple perspectives on clinical trials.

This month, we feature an overview of clinical trials as well as two webinars on metastatic clinical trials–one from the patients’ perspective and one from the oncologists’ perspective.

We also have included a video about the importance of research and clinical trials that features patient advocate Karen Durham. Karen died in March, a few months after the video was made. You can read more about her and her advocacy on the Komen website.

Clinical Trials: Who Gets to Take Part?

Learn more about why more patients will be eligible for clinical trials. It’s also important to know if outcomes and side effects differ based on a participant’s sex, race or age group. The FDA’s Drug Trials Snapshots allows you to see who took part in the clinical trials that led to a drug’s approval and what, if any, differences were seen. And Cancer Today, pulls it all together in this feature on efforts to increase the number and type of participants in clinical trials.