A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population

Study acronym: MiRaDoR
StatusActive, Not Recruiting
PhasePhase 2
SponsorMedSIR
Started

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Record History

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  1. Enrollment closed, study ongoing Show 4 more changesShow less
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 2 of 8 entries
    • Site details revised at 41 of 41 sites
    • Study description expanded, about 3 words
  2. Interventions: Abemaciclib (Drug), Giredestrant (Drug), Inavolisib (Drug) to Abemaciclib (Drug), Giredestrant (Drug), Inavolisib (Drug), Standard ET followed by change in treatment (Drug)
    • Eligibility criteria expanded, about 764 words
    • Secondary endpoints revised (8)
    • Study description expanded, about 379 words
    v16
  3. Enrollment target: 1260 to 976v15 Show 5 more changesShow less
    • Study sites: 32 to 41
    • Primary and study completion dates: Dec 30, 2028 to Jun 30, 2028
    • Eligibility criteria expanded, about 520 words
    • Secondary endpoints: details revised at 7 of 8 entries
    • Study description shortened, about 118 words
  4. Study sites: 30 to 32v14
  5. Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 23 to 30
    v13
Show 11 earlier versionsHide 11 earlier versions
  1. Re-verified, no change to tracked fieldsv12
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 23 of 23 sites
    v11
  3. Study sites: 22 to 23v10
  4. Study sites: 9 to 22v9
  5. Study sites: 3 to 9v8
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    v7
  7. Start date: Mar 1, 2024 to Apr 1, 2024v6
  8. Start date: Feb 1, 2024 to Mar 1, 2024v5
  9. Start date: Dec 31, 2023 to Feb 1, 2024v4
  10. Primary completion date: Dec 30, 2024 to Dec 30, 2028
    • Start date: Sep 30, 2023 to Dec 31, 2023
    • Study completion date: Mar 30, 2028 to Dec 30, 2028
    v3
  11. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
MedSIR
23 trials monitored
See all monitored trials
Breast Cancer
5,455 trials monitored
See 306 trials at risk
This trial is a multicenter, open-label, non-comparative, phase II, biomarker-driven adjuvant treatment study involving the periodic collection and analysis of blood samples from patients with HR-positive/HER2-negative early-stage BC at higher risk of relapse, who have undergone surgery within the previous five years, with no evidence of locoregional, contralateral, or distant disease. The study design is composed by an initial pre-screening phase, a molecular follow-up phase (ctDNA surveillance phase), and an interventional therapeutic phase (treatment phase). After informed consent is obtained, a total of 976 eligible patients will enter a ctDNA surveillance in which primary tumor tissue and matched normal blood will be collected from each patient to obtain a patient-specific somatic mutations panel (tumor signature). At the event of ctDNA positivity, patients will be screened to enter the treatment phase of the study. Upon confirmed eligibility, a total of 40 patients will be allocated in one of the following trial's arms adopting a sequential recruitment strategy: Arm A: Control Arm (N=10) Arm B: Experimental Arm with giredestrant (N=10) Arm C: Experimental Arm with giredestrant + abemaciclib (N=10) Arm D: Experimental Arm with giredestrant + inavolisib (N=10) If the strategy of ctDNA monitoring enables physicians to identify patients at high risk of relapse and assess whether treatment at molecular relapse can improve outcome, new cohorts may be added to the study.
Trial Details
NCT Number NCT05708235
Lead Sponsor MedSIR
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms, Neoplasm, Residual
Enrollment 976 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov