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A new approach aims to help breast cancer patients with heart risks take their pills consistently

NCT ID NCT06121453

Disease control Sponsor: Columbia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This trial tests a multicomponent adherence intervention designed to help patients with metastatic breast cancer and cardiovascular disease take their endocrine therapy, CDK4/6 inhibitors, and heart medications as prescribed. The study enrolls 35 adults who have reported some nonadherence. Researchers will measure changes in medication adherence and quality of life, and explore how social factors affect medication use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a multicomponent adherence intervention (behavioral support to reduce barriers to medication use)
What this could lead to
If effective, this approach could improve medication adherence and health outcomes for patients managing both metastatic breast cancer and cardiovascular disease.
What could go wrong
This is a small, early-stage trial with only 35 participants, so results may not apply broadly. The intervention relies on self-report and pharmacy data, which may not capture full adherence.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

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