ACT-MBC: A Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer (MBC) (ACT-MBC)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-001745
- Mankato, Minnesota: 21-001745
- Eau Claire, Wisconsin: 21-001745
- Albert Lea, Minnesota: 21-001745
NCT ID: NCT05662345
Sponsor Protocol Number: ACT-MBC
About this study
Collection of blood to track serial circulating tumor cells (CTCs) in subjects with metastatic breast cancer (MBC). Study will also collect data from investigators are Mayo Clinic and the Mayo Clinic Health Systems to determine effectiveness of the proposed process.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 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 in the metastatic setting OR ER/PR/HER2-negative (Triple Negative) patients prior to starting any line of therapy in the metastatic setting.
- Note: ER/PR/HER2 status is defined per the 2018 ASCO/CAP guidelines as follows: ER-positive and PR-positive is defined as ≥ 1% reactive cells by immunohistochemical staining. HER2 Negative Disease is defined by meeting one of the following criteria:
- 0 or 1+ by IHC and not amplified by ISH;
- 0 or 1+ by IHC and ISH not done;
- 2+ by IHC and ISH results are:
- < 6.0 HER2 signals/cell with HER2/CEP17 ratio < 2.0;
- IHC not done and not amplified by ISH.
- Measurable and/or non-measurable disease is allowed.
- Male or female breast cancer is allowed.
- Age > 18 years.
- Willingness to provide mandatory blood specimens.
- Willing to return to enrolling institution for follow up imaging at least once.
Exclusion Criteria:
- Life expectancy of ≤ 6 months.
- Inability to provide blood samples based on the judgment of the treating provider.
Eligibility last updated 12/20/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Karthik Giridhar, M.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Mankato, Minn.
Mayo Clinic principal investigator Amrit Singh, M.B.B.S. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
855-776-0015
|
Eau Claire, Wis.
Mayo Clinic principal investigator Eyad Al-Hattab, M.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
855-776-0015
|
Albert Lea, Minn.
Mayo Clinic principal investigator Mina Hanna, M.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
855-776-0015
|
More information
Publications
Publications are currently not available