Stage 4 Metastatic Breast Cancer Patient Survey

I’m excited to share some exciting work I’m involved with as a member of The Patient-Centered Dosing Initiative (PCDI).

In 2020, PCDI founder and dear friend, Anne Loeser, along with a small team of patient advocates, launched a patient survey to collect data on treatment-related side effects and how they were managed, knowing that many patients with stage IV metastatic breast cancer were experiencing side effects from the Oncology drugs they were taking that negatively impacted their quality of life.

This groundbreaking survey collected responses from 1,220 patients living with MBC. So impactful was the data, a paper was published, an abstract submitted to ASCO, resulting in Anne being invited to speak at one of largest cancer conferences in the world, ASCO (American Society of Clinical Oncology) in June 2021. Anne’s oral presentation got attention far and wide, by clinicians, researchers AND the FDA!

A few months later, the FDA published an opinion piece stating that patients have spoken, and it’s loud and clear that these drugs (Oncology/cancer treatments) are too toxic! Not long after, FDA launched 2 new projects to address how Oncology drug dosing is obtained and prescribed – Project Optimus, which seeks to address how early phase clinical trials determine dosing of new drugs, and Project Renewal, looking at already FDA approved drugs to determine if data exists that provides evidence of efficacy in a range of doses.

How is the optimal dose determined in Oncology? Historically, in early phase clinical trials, the goal is to find the MTD – maximum tolerated dose. This MTD is then the basis for drug labeling for the RSD ~ recommended starting dose. The problem is that these Phase I & 2 trials only include a very small number of patients, and once the drug is approved, real world patients who are prescribed the drug may not “tolerate” the drug at this recommended starting dose.

The FDA projects, along with the work PCDI is doing, seeks to find the optimal dose, a range of doses that patients can have access to, based upon their own unique personal characteristics. Because 99% of patients with MBC will be on treatment for life, the toxicities from the drugs used to treat the disease can significantly and negatively impact their quality of life. And, as my friend & PCDI lead, Julia Maues says ~ we don’t want to just live longer, we want to live better.

On April 14, 2025, the PCDI launched a new version of the Patient Survey. If you are living with stage 4 metastatic breast cancer, and are interested in taking the survey, please email [email protected] to receive a link, or visit our website www.therightdose.org/survey.

Also, please take a few minutes to listen to this Our MBC Life Podcast with Martha Carlson, Julia Maues, and Stephanie Walker, where more information about the 2020 Patient Survey, history of PCDI, and info about the second version of the patient survey can be found – https://www.ourmbclife.org/

breast cancer MBC Dosing Initiative Patient Survey Stage 4 Metastatic Breast Cancer The Right Dose

Last modified: April 28, 2025