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Adherence Intervention for Metastatic Breast Cancer

This study is testing a multi-part intervention to help patients with metastatic breast cancer (cancer that has spread) better stick to their prescribed medications. This includes endocrine therapy (ET), CDK4/6 inhibitors (CDK4/6i), and medications for heart disease risk factors like high blood pressure or cholesterol. The study aims to understand if this intervention helps patients take their medicines as prescribed and how well it works for them. You might be able to join if you are 18 or older, have metastatic breast cancer, are taking ET and a CDK4/6i, are also taking medication for heart disease prevention, and have reported some difficulty taking your medications. The study will measure how many participants are using the intervention after 28 weeks. The current status of the study is unclear, and it plans to enroll 35 people.

Study design
This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 35 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed at 28 weeks to see how many are on the multicomponent adherence intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06121453

Adherence Intervention in Patients With Metastatic Breast Cancer

Recruiting
NAAges 18–99InterventionalSupportive care
Columbia University
~35 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Multicomponent Adherence Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants on multicomponent adherence intervention
Measured over at 28 weeks

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
New York1

Who to contact

Research Nurse Navigator
[email protected]
212-342-5162
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Women or men age \>18 years
Diagnosed with stage IV/metastatic breast cancer prescribed endocrine therapy and a CDK4/6i
Prescribed at least 1 antihypertensive or statin medication for CVD prevention or treatment
Self-report of at least some nonadherence ET/CDK4/6i or CVD medication on nonadherence screener or verbally to a treating clinician, or nonadherent to ET, CDK4/6i, and/or CVD medication on pharmacy fill data in the EHR (proportion of days covered over prior 180 days \<80%).

Exclusion

Non-English or Non-Spanish speaking
Not cognitively able to complete study requirements
Inability to provide informed consent for any other reason (e.g, severe psychiatric illness, active substance use)
Unavailable for 28 weeks of follow-up

What this trial measures

  • Number of Participants on multicomponent adherence interventionat 28 weeks

    To determine the preliminary efficacy of a multicomponent adherence intervention that targets digital and pharmaco-equity among patients with metastatic breast cancer with at least some nonadherence to endocrine therapy, CDK4/6 inhibitor, and/or at least one oral cardiovascular disease (CVD) medication (either blood pressure or statin medication), based on its impact on concurrent adherence to endocrine therapy, CDK4/6 inhibitor, and to CVD medication at 28 weeks (or at time of progression of MBC, if prior to 28-week timepoint), assessed by a combination of self-report using the Voils DOSE Nonadherence measure and pharmacy fill data using pharmacy dispensing records available in the Electronic Health Record (EHR).