The Patient-Centered Dosing Initiative was started by MBC patient advocates, Anne Loeser and Julia Maués. This movement seeks to educate patients, doctors, and regulatory agencies such as the FDA that giving the right dose of MBC medications (a personalized dose of medication) is important for maximizing effectiveness and minimizing toxicities.
The FDA has taken action by starting Project Optimus, which has issued guidance to pharmaceutical companies to identify doses based on how well they work while minimizing side effects, rather than the highest dose, which is often too toxic. The Patient-Centered Dosing Initiative was highlighted in a workshop at SABCS 2024. Read the articles below to learn more about these efforts.
- Metastatic Trial Talk: Individualized Dosing for People with MBC
- Patient-Centered Dosing Initiative: Patient-Centered Dosing Initiative: The Patient-Centered Dosing Initiative (PCDI) advocates for cancer treatment that balances treatment effectiveness and quality of life
- Patient-Centered Dosing Initiative: The Patient-Centered Dosing Initiative (PCDI) is conducting a new survey about MBC treatment dosing and side effects
- Patient-Centered Dosing Initiative: The FDA is responding to the Patient-Centered Dosing Initiative’s survey findings by implementing Project Optimus (scroll to “FDA Action”)
- Our MBC Life (podcast): This podcast episode breaks down how treatment doses are typically determined during clinical trials and why individualized dosing, based on more than your diagnosis, is so important for people living with metastatic breast cancer
- FDA: Project Optimus provides guidance to pharmaceutical companies so they can select dose(s) that maximize how well a drug works as well as safety and the patient’s ability to tolerate the drug
- Living Beyond Breast Cancer: A workshop at SABCS 2024 was convened to discuss patient-centered dosing efforts
Last Modified on April 24, 2025