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

Menarini

Status: Active, not recruiting

Conditions: Metastatic Breast Cancer

Treatments: Diagnostic Test: CellSearch Circulating Tumor Cells

Study type: Observational

Funder types: Industry

Identifiers

NCT05662345

ACT-MBC

Details and patient eligibility

About

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

Enrollment: 65 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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