Clinical trial · Observational
Molecular Surveillance In Early Breast Cancer Using The Tumor-Informed ctDNA Assay Myriad Genetics Precise MRD Test; A Prospective Observational Multicenter Study (The MRD Molecular Surveillance Study)
NCT07475923CI-TRIAL-00108499withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI requested
Summary
Brief summary (as posted)
To learn about changes in ctDNA during the diagnosis, treatment, and post-treatment surveillance of EBC.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| ctDNA | — | UNRESOLVED | — |
| Molecular Surveillance | — | UNRESOLVED | — |
| MRD | — | UNRESOLVED | — |
| Observational Study | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draw for the laboratory assessment | Diagnostic Test | — | UNRESOLVED |
| Neoadjuvant treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- Arm A
- description
- Participants in Arm A are receiving neoadjuvant therapy (treatment before breast surgery)
- interventionNames
- Diagnostic Test: Blood draw for the laboratory assessment
- Drug: Neoadjuvant treatment
- label
- Arm B
- description
- Participants in Arm B have early-stage triple negative breast cancer (TNBC) or HER2-positve (HER2+) breast cancer.
- interventionNames
- Diagnostic Test: Blood draw for the laboratory assessment
- Drug: Neoadjuvant treatment
- label
- Arm C
- description
- Participants in Arm C are receiving adjuvant therapy (treatment after breast surgery) with a CDK4/6-inhibitor (such as abemaciclib or ribociclib).
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Eligibility Criteria * Men or women who have a diagnosis of histological confirmed EBC (stage I, II or III) of any histopathology and any subtype (hormone-receptor positive or negative, HER2-positive, or negative). * Have tumor tissue available of sufficient quality for processing by Myriad Genetics. * Participant must be willing to provide serial blood samples at specific timepoints specific for each subgroup of interest per the Schedule of Activities * Age ≥18 years at enrollment * Arm A: Participants undergoing neoadjuvant systemic therapy: those with newly diagnosed untreated EBC of any subtype, stage I-II-II, who are scheduled to receive neoadjuvant systemic therapy of any type (i.e. chemotherapy, targeted therapy, immunotherapy, endocrine therapy) including a combination of agents, prior to undergoing breast surgery * Arm B: Participants with TNBC or HER2-positive EBC (T1a, T1b, N0): those with newly diagnosed and untreated TNBC or HER2-positive EBC who have a plan to undergo upfront breast surgery as part of their standard of care treatment * Arm C: Participants who receive an adjuvant CDK4/6-inhibitor (i.e., abemaciclib or ribociclib): those who have a diagnosis of hormone-receptor positive, HER2-negative, stage I-II-III EBC who have a plan to receive adjuvant abemaciclib or adjuvant ribociclib as part of their standard of care treatment * Arm D: Participants who receive an adjuvant PARP-inhibitor (i.e., olaparib): those who have a germline pathogenic mutation (i.e. BRCA) and a diagnosis of hormone-receptor positive or negative, HER2-negative, stage I-II-III EBC, and have a plan to receive an adjuvant PARPinhibitor as part of their standard of treatment plan * Arm E: Participants who develop ipsilateral locoregional recurrence (ILRR): those who have a diagnosis of EBC of any subtype, stage I-II-II and have completed local therapy (i.e. breast surgery and/or radiation therapy) and develop biopsy-proven locoregional disease recurrence in the ipsilateral breast and/or ipsilateral regional nodal basins * Arm F: Participants who completed local therapy and are 5 or more years out from breast surgery: those who have a diagnosis of EBC of any subtype, stage I-II-II, and have completed local therapy (i.e. breast surgery and/or radiation therapy), and are 5 or more years out from local therapy and do not have clinical evidence of disease Exclusion Criteria * Participants with distant cancer metastases (beyond locoregional disease recurrence) * Participants with cognitive impairment/psychiatric illness/social situations that would limit compliance with study requirements. * Current or recent (within the last year) diagnosis of another primary malignancy (except skin cancer and non-invasive cancer) * Personal history of allogenic bone marrow or organ transplant * Participants who are pregnant
References
Publications (0)
Data not yet available
No reference posted for this study.