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

NCT ID: NCT05662345

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-12

Study Completion Date

2026-10-30

Brief Summary

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

Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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CellSearch Circulating Tumor Cells

Serial CTC enumeration

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medex15

INDUSTRY

Sponsor Role collaborator

Menarini Silicon Biosystems, INC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mayo Clinic Health System Albert Lea

Albert Lea, Minnesota, United States

Site Status

Mayo Clinic Health System Mankato

Mankato, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

MCHS Eau Claire

Eau Claire, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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ACT-MBC

Identifier Type: -

Identifier Source: org_study_id

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