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

Sponsor

Menarini Silicon Biosystems, INC (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05662345

Collaborator

Medex15 (Other)

Enrollment

Locations

24.6

Anticipated Duration (Months)

32.5

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer	Diagnostic Test: CellSearch Circulating Tumor Cells

Study Design

Study Type:

Observational

Anticipated Enrollment :

65 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 12, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905
2	MCHS Eau Claire	Eau Claire	Wisconsin	United States	54703

Sponsors and Collaborators

Menarini Silicon Biosystems, INC
Medex15

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Menarini Silicon Biosystems, INC

ClinicalTrials.gov Identifier:

NCT05662345

Other Study ID Numbers:

ACT-MBC

First Posted:

Dec 22, 2022

Last Update Posted:

Dec 22, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Breast Neoplasms

Neoplastic Cells, Circulating

Study Results

No Results Posted as of Dec 22, 2022