Metastatic Breast Cancer Clinical Trial
— ACT-MBCOfficial title:
ACT-MBC: A Prospective Observational Impact Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer
ACT-MBC prospectively assesses the impact of CTCs on treatment decisions, response assessment and prognosis in MBC patients.
| Status | Recruiting |
| Enrollment | 65 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | December 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic Health System Albert Lea | Albert Lea | Minnesota |
| United States | MCHS Eau Claire | Eau Claire | Wisconsin |
| United States | Mayo Clinic Health System Mankato | Mankato | Minnesota |
| United States | Mayo Clinic | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Menarini Silicon Biosystems, INC | Medex15 |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To prospectively evaluate the impact of CellSearch CTCs on treatment decisions and response assessment in MBC patients | Assessing proportion of providers that find CellSearch CTCs helpful in determining response to therapy in each unique patient (Questionnaire #2). | 3 to 4 months | |
| Secondary | Assess barriers and receptiveness of providers in using CTCs in clinical practice | Assessing provider perception of the general usefulness of CTC in pre and post-intervention surveys (Questionnaire #1 and #3) | 18 months | |
| Secondary | Evaluate if CTC results correlate with response assessment and disease progression defined by standard of care imaging | Compare baseline and on treatment serial CTCs assessment to identify correlations with first restaging studies and with progression free survival | 18 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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