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Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)

Study acronym: TREAT ctDNA
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Study sites: 112 to 113
    • Eligibility criteria expanded, about 61 words
    • Secondary endpoints: details revised at 5 of 7 entries
    • Study description expanded, about 4 words
  2. Study sites: 111 to 112v8
  3. Site details revised at 1 of 111 sitesv7
  4. Study sites: 109 to 111v6
  5. Study sites: 94 to 109
    • Eligibility criteria expanded, about 27 words
    • Collaborators: 2 to 10
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: Jul 1, 2028 to Nov 1, 2032v4 Show 5 more changesShow less
    • Study sites: 42 to 94
    • Study completion date: May 1, 2030 to Nov 1, 2035
    • Eligibility criteria expanded, about 322 words
    • Secondary endpoints: 1 to 7
    • Study description expanded, about 534 words
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 42
    v3
  3. Start date: May 1, 2023 to Dec 15, 2023
    • Study title expanded, about 9 words
    • Eligibility criteria expanded, about 1 word
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
This is an international, multi-center, randomised, open label, superiority phase III trial of elacestrant vs standard endocrine therapy in patients with ER+/HER2- breast cancer and ctDNA relapse. During the ctDNA screening phase, patients will be tested at different timepoints to detect the presence of ctDNA in their blood. Patients who are found to be ctDNA-positive and have no evidence of distant metastasis, will be randomised 1:1 between standard endocrine treatment (the same they were receiving when tested ctDNA positive) versus elacestrant, provided they meet all eligibility criteria. After completion of the protocol treatment period, treatment will be left at the discretion of the treating physician.
Trial Details
NCT Number NCT05512364
Lead Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Collaborators: Menarini Group, Natera, Inc., Borstkanker Onderzoek Groep, Cancer Trials Ireland, SOLTI Breast Cancer Research Group, ETOP IBCSG Partners Foundation, SUCCESS, Hellenic Cooperative Oncology Group, Hellenic Oncology Research Group, Swedish Breast Cancer Group
Conditions
(from sponsor)		 ER-positive Breast Cancer, HER2-negative Breast Cancer, Stage IIB Breast Cancer, Stage III Breast Cancer
Related terms Breast Neoplasms
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov