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

ACT-MBC: A Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer (MBC)
warning The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05662345
Recruitment Status : **RECRUITING NOW**

First Posted : December 22, 2022

Last Update Posted : December 22, 2022

Sponsor:

Collaborator:

Information provided by (Responsible Party):

Menarini Silicon Biosystems, INC

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Brief Summary:

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

Metastatic Breast Cancer Diagnostic Test: CellSearch Circulating Tumor Cells

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Study Type : Observational
Estimated Enrollment : 65 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: ACT-MBC: A Prospective Observational Impact Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer
Actual Study Start Date : December 12, 2022
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : December 31, 2024
Resource links provided by the National Library of Medicine NIH NLM ABRV BLK 4

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Intervention Details:

  • Diagnostic Test: CellSearch Circulating Tumor Cells

    Serial CTC enumeration

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Primary Outcome Measures :

  1. 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 Outcome Measures :

  1. Assess barriers and receptiveness of providers in using CTCs in clinical practice [ Time Frame: 18 months ]

    Assessing provider perception of the general usefulness of CTC in pre and post-intervention surveys (Questionnaire #1 and #3)

  2. Evaluate if CTC results correlate with response assessment and disease progression defined by standard of care imaging [ Time Frame: 18 months ]

    Compare baseline and on treatment serial CTCs assessment to identify correlations with first restaging studies and with progression free survival

Biospecimen Retention:   Samples With DNA

Cell-Free DNA (cfDNA)

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Information from the National Library of Medicine NIH NLM ABRV BLK 4

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample

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

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

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Responsible Party: Menarini Silicon Biosystems, INC
ClinicalTrials.gov Identifier: NCT05662345    
Other Study ID Numbers: ACT-MBC
First Posted: December 22, 2022    Key Record Dates
Last Update Posted: December 22, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

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Breast Neoplasms
Neoplastic Cells, Circulating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

December 26, 2022Comments OffClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine
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