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Blood test may help Fine-Tune breast cancer medication levels

NCT ID NCT06572800

Knowledge-focused Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a blood test called DiviTum-TKa can help doctors check if patients with metastatic breast cancer are taking their CDK4/6 inhibitor medication correctly and if other drugs are interfering. The test measures a marker of cell growth to see if the treatment is working well. The goal was to see if adjusting medication based on test results could improve treatment response in 34 patients.

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

34 people

The number who actually took part.

Started

Sep 2023

Finished

Sep 2025

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 years and older

Sex

Female participants only

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: * Participants must have histologically confirmed metastatic ER-positive (\> 10%), PR-positive or PR-negative, and HER2-negative (0 by immunohistochemistry \[IHC\] or if +1 or +2 by IHC, not amplified by fluorescence in situ hybridization \[FISH\]) breast cancer; ER positivity, PR positivity, and HER2 negativity as per the 2018 joint American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. * Participants must be starting CDK4/6 inhibitor and endocrine therapy as part of first-line therapy per standard of care and be previously CDK4/6 inhibitor-naïve. * Participants must be enrolled prior to starting CDK4/6 inhibitor therapy. * Participants must be ≥ 18 years of age. * Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status \< 3. * Willing and able to provide written informed consent for the trial. Exclusion Criteria: * Participants without evidence of metastatic disease prior to registration. * Participants with prior use of CDK4/6 inhibitor therapy. * Participants who are unable to provide informed consent for the trial.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma Her2-receptor negative breast cancer

As listed by the trial registrant

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

Anatomic stage IV breast cancer ajcc V8 Metastatic HER2-negative breast carcinoma

Contacts and locations

Locations

  • Smilow Cancer Center/Yale-New Haven Hospital

    New Haven, Connecticut, 06510, United States

  • Smilow Cancer Hospital Care Center - Guilford

    Guilford, Connecticut, 06437, United States

  • Smilow Cancer Hospital Care Center - Waterford

    Waterford, Connecticut, 06385, United States

  • Smilow Cancer Hospital Care Center - Westerly

    Westerly, Rhode Island, 02891, United States

  • Smilow Cancer Hospital Care Center at Glastonbury

    Glastonbury, Connecticut, 06033, United States

  • Smilow Cancer Hospital Care Center at Greenwich

    Greenwich, Connecticut, 06830, United States

  • Smilow Cancer Hospital Care Center at Long Ridge

    Stamford, Connecticut, 06902, United States

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105, United States

  • Smilow Cancer Hospital Care Center-Fairfield

    Fairfield, Connecticut, 06824, United States

  • Smilow Cancer Hospital Care Center-Trumbull

    Trumbull, Connecticut, 06611, United States

  • Smilow Cancer Hospital-Derby Care Center

    Derby, Connecticut, 06418, United States

  • Smilow Cancer Hospital-Hamden Care Center

    Hamden, Connecticut, 06518, United States

  • Smilow Cancer Hospital-Orange Care Center

    Orange, Connecticut, 06477, United States

  • Smilow Cancer Hospital-Torrington Care Center

    Torrington, Connecticut, 06790, United States

  • Smilow Cancer Hospital-Waterbury Care Center

    Waterbury, Connecticut, 06708, United States

  • Yale University

    New Haven, Connecticut, 06520, United States

  • Yale-New Haven Hospital North Haven Medical Center

    North Haven, Connecticut, 06473, United States

  • Yale-New Haven Hospital Saint Raphael Campus

    New Haven, Connecticut, 06511, United States

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