ACT-MBC: A Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer (MBC)

N/AActive Not RecruitingNCT05662345

Menarini Silicon Biosystems, INC65 enrolled

Overview

ACT-MBC prospectively assesses the impact of CTCs on treatment decisions, response assessment and prognosis in MBC patients.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Metastatic Breast Cancer

Interventions

CellSearch Circulating Tumor CellsDIAGNOSTIC_TEST

Serial CTC enumeration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Mayo Clinic Health System Albert Lea

Albert Lea, Minnesota, United States

Mayo Clinic Health System Mankato

Mankato, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

MCHS Eau Claire

Eau Claire, Wisconsin, United States

Outcomes

Primary Outcomes

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).

Time frame: 3 to 4 months

Secondary Outcomes

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)

Time frame: 18 months

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

Time frame: 18 months

Data from ClinicalTrials.gov

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