Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT05662345
NCT05662345Active, not recruitingNot Applicable

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

Menarini Silicon Biosystems, INC4 sites in 1 country65 target enrollmentStarted: December 12, 2022Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
65
Locations
4
Primary Endpoint
To prospectively evaluate the impact of CellSearch CTCs on treatment decisions and response assessment in MBC patients
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Invasive breast cancer with radiographic and/or clinical evidence of advanced metastatic or unresectable disease
  • •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
  • •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

Outcomes

Primary Outcomes

To prospectively evaluate the impact of CellSearch CTCs on treatment decisions and response assessment in MBC patients

Time Frame: 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 Outcomes

  • Assess barriers and receptiveness of providers in using CTCs in clinical practice(18 months)
  • Evaluate if CTC results correlate with response assessment and disease progression defined by standard of care imaging(18 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

Loading locations...

Similar Trials

Terminated
Not Applicable
Effectiveness of TCC Followed by MBCT and Predictive Factors (Genetic, Clinical and Cognitive) ResponseAnxious DisorderBipolar DisorderAlcohol Dependence
NCT02472483Centre Hospitalier St Anne158
Completed
Phase 1
Cognitive-Behavioral Treatment of GamblingGamblingMental Health
NCT00118391UConn Health120
Completed
Not Applicable
Comparing the Effectiveness of a Treat-to-target (T2T) Disease Management Strategy vs. Routine Care (RC) in Adult Patients With Moderate to Severe Rheumatoid Arthritis (RA) Treated With Subcutaneous Abatacept (Orencia - SC)Rheumatoid Arthritis
NCT03274141Bristol-Myers Squibb281
Completed
Not Applicable
The Impact of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Glycemic Control in Older Type 2 Diabetes (T2D) Comorbid With InsomniaDiabetes Mellitus, Type 2Insomnia
NCT04831385Chinese University of Hong Kong214
Withdrawn
Not Applicable
Comparing Efficacy of Bone Marrow Aspirate Concentrate (BMAC) Combined With Allograft in Treatment of Calcaneus FracturesFractures, Bone
NCT05017961University of Alabama at Birmingham