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

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT05512364
Phase
PHASE3
Status
Recruiting
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Conditions

  • ER-positive Breast Cancer
  • HER2-negative Breast Cancer
  • Stage IIB Breast Cancer
  • Stage III Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Elacestrant — DRUG
    400mg QD orally on a continuous dosing schedule
  • Tamoxifen — DRUG
    20 mg QD orally on a continuous dosing schedule
  • Letrozole 2.5mg — DRUG
    2.5 mg QD orally on a continuous dosing schedule
  • Anastrozole 1mg — DRUG
    1 mg QD orally on a continuous dosing schedule
  • Exemestane 25 MG — DRUG
    25 mg QD orally on a continuous dosing schedule

Study Details

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.

Key Dates

First listed
Aug 23, 2022
Start date
Dec 15, 2023
Status verified
May 2026
Primary completion
Nov 1, 2032
Completion
Nov 1, 2035

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental arm
    elacestrant 400 mg/day orally once daily on a continuous dosing schedule
  • Active Comparator: Control arm
    standard endocrine treatment - the same they were receiving at the time of ctDNA detection

Primary Outcome Measure

Distant metastasis free survival (DMFS) [ Time Frame: Final DFMS will be 6.25 years after the first patient randomised. ]

Central Contacts

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