ACT-MBC: A Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer (MBC) (ACT-MBC)

March 16, 2026 updated by: Menarini Silicon Biosystems, INC

ACT-MBC: A Prospective Observational Impact Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer

ACT-MBC prospectively assesses the impact of CTCs on treatment decisions, response assessment and prognosis in MBC patients.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Albert Lea, Minnesota, United States, 56007
        • Mayo Clinic Health System Albert Lea
      • Mankato, Minnesota, United States, 56001
        • Mayo Clinic Health System Mankato
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54703
        • MCHS Eau Claire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To prospectively evaluate the impact of CellSearch CTCs on treatment decisions and response assessment in MBC patients
Time Frame: 3 to 4 months
Assessing proportion of providers that find CellSearch CTCs helpful in determining response to therapy in each unique patient (Questionnaire #2).
3 to 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess barriers and receptiveness of providers in using CTCs in clinical practice
Time Frame: 18 months
Assessing provider perception of the general usefulness of CTC in pre and post-intervention surveys (Questionnaire #1 and #3)
18 months
Evaluate if CTC results correlate with response assessment and disease progression defined by standard of care imaging
Time Frame: 18 months
Compare baseline and on treatment serial CTCs assessment to identify correlations with first restaging studies and with progression free survival
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menarini Silicon Biosystems, INC

Collaborators

Medex15

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2022

Primary Completion (Actual)

November 14, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

December 14, 2022

First Submitted That Met QC Criteria

December 21, 2022

First Posted (Actual)

December 22, 2022

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACT-MBC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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