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

Active, not recruiting

• Conditions: Metastatic Breast Cancer

• Registration Number: NCT05662345
• Lead Sponsor: Menarini Silicon Biosystems, INC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-12
• Study First Submitted: 2022-12-14
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2022-12-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-09-01
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To prospectively evaluate the impact of CellSearch CTCs on treatment decisions and response assessment in MBC patients	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 Outcome Measures

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

Trial Locations

Locations (4)

Mayo Clinic Health System Albert Lea; 🇺🇸 Albert Lea, Minnesota, United States

Mayo Clinic Health System Mankato; 🇺🇸 Mankato, Minnesota, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

MCHS Eau Claire; 🇺🇸 Eau Claire, Wisconsin, United States