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EAQ221CD – Improving Medication Adherence in Metastatic Breast Cancer using a CONnected CUstomized Treatment Platform (CONCURxP)
The study chair for this trial is Gelareh Sadigh, MD (University of California, Irvine). The study co-chair is Ilana Graetz, PhD (Emory University/Winship Cancer Institute).
In 2023, an estimated 300,000 people in the United States will be diagnosed with invasive breast cancer. Approximately 6% will have metastatic breast cancer (MBC) when they are first diagnosed—and an additional 30% with early-stage disease will develop MBC over their lifetime. MBC is incurable, so treatment is focused on extending patients’ survival and improving their quality of life (QOL).
Approximately 60-65% of patients with breast cancer have hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) disease. For them, there is the option to take an oral CDK4/6 inhibitor, including palbociclib, ribociclib, or abemaciclib. These FDA-approved treatments have been shown to double progression-free survival when one is added to hormone therapy. Further, CDK4/6 inhibitors produce a significant overall survival (OS) benefit, with an increase in 5-year OS from 16.8% to 23.2%. Thus, it is critical to provide interventions that support patients in their efforts to adhere to oral CDK4/6 inhibitor therapy.
In a survey of MBC patients, across all oral treatment medications, forgetfulness was the most common reason for non-adherence, followed by side effects. Because CDK4/6 inhibitors have complex dosing schedules, they can be more difficult to manage than other oral treatments—especially for patients who struggle with forgetfulness. The addition of CDK4/6 inhibitors to endocrine therapy is also known to be associated with various treatment-related side effects. A third common barrier to adherence was cost. CKD4/6 inhibitors are expensive, and patients may face high cost-sharing or insurance denials.
The EAQ221CD/CONCURxP study aims to address these barriers. The study plans to enroll 390 patients with HR+/HER2- MBC, and all participants will be asked to have their medication monitored using the WisebagTM. This portable device, which looks like a pouch or lunch bag, has been in use in the broader medical community for several years. It automatically tracks when the device is opened and marks the dose as ‘taken’ in real time directly from the device to an online server without requiring a smartphone.
Participants will be randomized 1:1 to receive either the control arm (usual use of the Wisebag) or the experimental arm (Wisebag plus CONCURxP, the connected customized treatment platform). The intervention will be offered in both English and Spanish.
Following is a summary of the CONCURxP interventional features:
- Provides personalized and interactive text messages notifying patients of missed or double doses and allows them to report reasons for any missed or double doses
- Notifies the provider team to call patients for a personalized clinical intervention when adherence drops below or exceeds a pre-determined threshold
- Connects patients with the Patient Advocate Foundation, a national non-profit financial navigation program, to assist with financial concerns
- Allows the participant and provider team to track real-time adherence using a study web portal
The trial’s primary objective is to compare CDK4/6 inhibitor adherence between the two groups at 12 months after the initiation of medication. The hypothesis is that CONCURxP patients will have higher adherence.
Learn more about EAQ221CD/CONCURxP at ecog-acrin.org.