CellSearch Circulating Tumor Cells: Serial CTC enumeration
Study summary
ACT-MBC prospectively assesses the impact of CTCs on treatment decisions, response assessment and prognosis in MBC patients.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
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).
Trial sites (4)
Facility
City
Region
Status
Mayo Clinic Health System Albert Lea
Albert Lea
Minnesota
Mayo Clinic Health System Mankato
Mankato
Minnesota
Mayo Clinic
Rochester
Minnesota
MCHS Eau Claire
Eau Claire
Wisconsin
More Menarini Silicon Biosystems, INC trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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