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

NCT05662345 | Active Not Recruiting FDA Device

• 1 other identifier: ACT-MBC
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• To prospectively evaluate the impact of CellSearch CTCs on treatment decisions and response assessment in MBC patients

  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 Outcomes (2)

• Assess barriers and receptiveness of providers in using CTCs in clinical practice

  18 months

• Evaluate if CTC results correlate with response assessment and disease progression defined by standard of care imaging

  18 months

Interventions

CellSearch Circulating Tumor Cells DIAGNOSTIC_TEST

Serial CTC enumeration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Menarini Silicon Biosystems, INC: lead
• Medex15: collaborator

Study Sites (4)

Mayo Clinic Health System Albert Lea

Albert Lea, Minnesota, 56007, United States

Location

Mayo Clinic Health System Mankato

Mankato, Minnesota, 56001, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MCHS Eau Claire

Eau Claire, Wisconsin, 54703, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cell-Free DNA (cfDNA)

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 22, 2022
• Study Start: December 12, 2022
• Primary Completion: November 14, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

US (4)