Metastatic Breast Cancer
Conditions
Brief summary
ACT-MBC prospectively assesses the impact of CTCs on treatment decisions, response assessment and prognosis in MBC patients.
Interventions
DIAGNOSTIC_TESTCellSearch Circulating Tumor Cells
Serial CTC enumeration
Sponsors
Menarini Silicon Biosystems, INC
Medex15
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed