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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
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 |
| 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 |
- Diagnostic Test: CellSearch Circulating Tumor Cells
Serial CTC enumeration
- 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).
- 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)
- 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: Â Samples With DNA
Cell-Free DNA (cfDNA)
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.
| Ages Eligible for Study:  | 18 Years and older  (Adult, Older Adult) |
| Sexes Eligible for Study: Â | All |
| Accepts Healthy Volunteers: Â | No |
| Sampling Method: Â | 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:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05662345
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Karthik Giridhar     giridhar.karthik@mayo.edu   | |
| MCHS Eau Claire | |
| Eau Claire, Wisconsin, United States, 54703 | |
| Contact: Eyad Al-Hattab     Hattab.Eyad@mayo.edu   | |
Menarini Silicon Biosystems, INC
Medex15
| Responsible Party: | Menarini Silicon Biosystems, INC |
| ClinicalTrials.gov Identifier: | NCT05662345 Â Â |
| Other Study ID Numbers: | ACT-MBC |
| First Posted: | December 22, 2022 Â Â Key Record Dates |
| Last Update Posted: | December 22, 2022 |
| Last Verified: | December 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| 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:
| 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.
