Introduction to MBC Clinical Trials

The idea of finding and participating in a clinical trial can seem daunting. We are here to help. Read here about clinical trials, how they work, why they are important, and how to find a trial that may be right for you.

Commonly Used Terms in Clinical Trials

The lists of eligibility criteria for clinical trials are often long and confusing. So are some terms used to describe the trial types, like dose-escalation, dose-expansion, maximum effective dose, and most effective dose.

Below are links to dictionaries that provide good definitions for and explanations of common terms used in cancer research. When in doubt, contact your doctor or the research team if you have a question about the goals of a study or whether you meet the eligibility criteria.

Tips for Reading Cancer News

Groundbreaking. Game-changing. Promising. These are just some of the words often seen in media coverage of new cancer treatments. But how does a reader or viewer know what’s really groundbreaking and what’s just hype?

Below you will find three articles that explore challenges health care reporters face and biases that can affect what is covered and how.

We’ve also provided five articles that provide tips on how to read health news and how to spot misleading news coverage.

And don’t miss the link to FORCE’s XRAY–Behind the Metastatic Breast Cancer Headlines. XRAY: MBC reviews and rates articles about metastatic breast cancer.

Challenges health care reporters face:

Tips on how to read health news:

What Do Drug Names Mean?

Have you ever wondered: How did trastuzumab (Herceptin) get its name? Or why is the biosimilar for Herceptin called trastuzumab-anns (Kanjinti)?

As the articles below explain, the names of cancer drugs are driven by science and advertising. Each new drug starts off with a name comprised of letters or numbers that means something only to the company that created it. If studies show that the drug is beneficial, and if it is approved by the FDA, it will get a generic name and a brand name. The generic name will contain clues to how the drug works or if it is a biosimilar. Brand names will be chosen based on what companies hope to portray, and what the FDA will allow.

Read on to learn more about the art and science of how drugs get their names.

And for a refresher on biosimilars, check out this past issue of MTT.

OS vs. PFS: What You Need to Know

Clinical trials are set up to look at specific outcomes. Click to read about how progression-free survival (PFS) and overall survival (OS) are used to measure treatment effectiveness.

True or False?

You may be treated with only a placebo in a metastatic breast cancer clinical trial. 

 

Answer: False

A patient with metastatic breast cancer will never receive only a placebo in a clinical trial.

It is possible that a placebo could be given along with the new treatment. But that would only occur if the new treatment was being given along with another drug, and the researchers wanted to see if the two-drug combination had different safety and effects than the one drug alone.

Also, if standard therapy is available, a patient may receive the standard therapy plus the new therapy or the standard therapy plus a placebo. But the patient would never receive the placebo alone.

You can learn more about how and when placebos are used in clinical trials below.

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: