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Blood test could revolutionize breast cancer treatment decisions

NCT ID NCT05662345

Knowledge-focused Sponsor: Menarini Silicon Biosystems, INC 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tracks 65 people with metastatic breast cancer to see if a blood test that finds cancer cells (called circulating tumor cells) helps doctors choose the right treatment and check if it's working. Participants give blood samples and doctors answer surveys about how useful the test is. The goal is to learn whether this test improves care, not to test a new drug.

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.

Participants

About 65 people

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

Started

Dec 2022

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Advanced/metastatic breast cancer of following subtypes/lines of systemic therapy in metastatic setting: * Estrogen Receptor (ER)+/Human Epidermal growth factor Receptor 2 (HER2) - patients prior to starting 2nd line or later therapy * Triple Negative (TN) patients prior to starting any line of systemic therapy

Ages

18 years and older

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: 1. Invasive breast cancer with radiographic and/or clinical evidence of advanced metastatic or unresectable disease 2. ER+/HER2- patients prior to starting 2nd line therapy or beyond OR ER/Progesterone Receptor (PR)/HER2-negative (Triple Negative) patients prior to starting any line of therapy 3. Measurable and/or non-measurable disease is allowed 4. Male or female breast cancer is allowed 5. Age \> 18 years 6. Willingness to provide mandatory blood specimens 7. Willing to return to enrolling institution for follow up imaging at least once Exclusion Criteria: 1. Life expectancy of ≤ 6 months 2. Inability to provide blood samples based on the judgment of the treating provider

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm

As listed by the trial registrant

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

Metastatic breast cancer

Contacts and locations

Locations

  • MCHS Eau Claire

    Eau Claire, Wisconsin, 54703, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Health System Albert Lea

    Albert Lea, Minnesota, 56007, United States

  • Mayo Clinic Health System Mankato

    Mankato, Minnesota, 56001, United States

More trials for these conditions

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