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Trial Title:
ACT-MBC: A Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer (MBC)
NCT ID:
NCT05662345
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Neoplastic Cells, Circulating
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
CellSearch Circulating Tumor Cells
Description:
Serial CTC enumeration
Summary:
ACT-MBC prospectively assesses the impact of CTCs on treatment decisions, response
assessment and prognosis in MBC patients.
Criteria for eligibility:
Study pop:
Advanced/metastatic breast cancer of following subtypes/lines of systemic therapy in
metastatic setting:
- Estrogen Receptor (ER)+/Human Epidermal growth factor Receptor 2 (HER2) - patients
prior to starting 2nd line or later therapy
- Triple Negative (TN) patients prior to starting any line of systemic therapy
Sampling method:
Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic Health System Albert Lea
Address:
City:
Albert Lea
Zip:
56007
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mina Hanna, MD
Email:
Hanna.Mina@mayo.edu
Investigator:
Last name:
Mina Hanna, MD
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic Health System Mankato
Address:
City:
Mankato
Zip:
56001
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amrit Singh, MBBS
Email:
Singh.Amrit@mayo.edu
Investigator:
Last name:
Amrit Singh, MBBS
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Karthik Giridhar
Email:
giridhar.karthik@mayo.edu
Facility:
Name:
MCHS Eau Claire
Address:
City:
Eau Claire
Zip:
54703
Country:
United States
Status:
Recruiting
Contact:
Last name:
Eyad Al-Hattab
Email:
Hattab.Eyad@mayo.edu
Start date:
December 12, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Menarini Silicon Biosystems, INC
Agency class:
Industry
Collaborator:
Agency:
Medex15
Agency class:
Industry
Source:
Menarini Silicon Biosystems, INC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05662345
