Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer

Sponsor
SOLTI Breast Cancer Research Group
Study ID
NCT05982093
Phase
PHASE2
Status
Recruiting
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Conditions

  • Breast Cancer
  • HER2-negative Breast Cancer
  • Hormone Receptor Positive Tumor
  • Premenopausal Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
35 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Elacestrant — DRUG
    Elacestrant 400 mg given orally on a daily and continuous basis for 30 days or until the day before surgery or biopsy (+7 extra days).
  • Triptorelin — DRUG
    Monthly triptorelin 3.75 mg powder and solvent for prolonged-release suspension for injection. Each vial contains 3.75 mg of triptorelin (acetate). After reconstitution with 2 ml of solvent, 1 ml of the suspension contains 1.875 mg triptorelin. This drug contains sodium, but less than 1 mmol (23 mg) of sodium per vial.Triptorelin will be administrated on D1 and D29.
  • Tamoxifen 20 mg — DRUG
    Tamoxifen 20 mg given orally on a daily and continuous basis for 30 days or until the day before surgery or biopsy (+7 extra days).

Study Details

PREMIERE parallel, non-comparative, two-arm, randomized 1:1, open-label, multicenter, exploratory window of opportunity study in premenopausal women with primary operable HR+/HER2-negative breast cancer with aiming at evaluating the biological effects of elacestrant with or without triptorelin.

Key Dates

First listed
Aug 8, 2023
Start date
Feb 3, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Elacestrant
    without ovarian function suppression
  • Active Comparator: Elacestrant + Triptorelin
    with ovarian function suppression
  • Active Comparator: Tamoxifen
    monotherapy

Primary Outcome Measure

To evaluate the biological activity of elacestrant with or without OFS in premenopausal women with ER+/HER2- operable EBC [ Time Frame: After 30 days (+7 days) of therapy ]

Central Contacts

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