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NCT Number: NCT05662345

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Health System Albert Lea, Albert Lea, Minnesota, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Invasive breast cancer with radiographic and/or clinical evidence of advanced metastatic or unresectable disease
  • 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
  • Measurable and/or non-measurable disease is allowed
  • Male or female breast cancer is allowed
  • Age > 18 years
  • Willingness to provide mandatory blood specimens
  • Willing to return to enrolling institution for follow up imaging at least once

Exclusion criteria

  • Life expectancy of ≤ 6 months
  • Inability to provide blood samples based on the judgment of the treating provider

Treatment and study plan

CellSearch Circulating Tumor Cells

Diagnostic Test

Serial CTC enumeration

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

  2. 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

Sponsors and collaborators

Lead sponsor

Menarini Silicon Biosystems, INC

Industry

Collaborators

  • Medex15

Registry information

Official study title

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

Acronym: ACT-MBC

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Dec 22, 2022
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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