Actively Recruiting
Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer
Led by SOLTI Breast Cancer Research Group · Updated on 2026-04-24
96
Participants Needed
15
Research Sites
199 weeks
Total Duration
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AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Female aged 35 years or older at consent
- Premenopausal status confirmed by recent menstrual period within 6 months or premenopausal hormone levels
- Histologically confirmed, operable, non-metastatic HR+/HER2- invasive breast cancer larger than 1 cm
- Tumor with ER expression over 10% and HER2 negativity by local guidelines
- Ki67 expression between 10% and 35%
- ECOG performance status 0 to 1
- Breast cancer suitable for primary surgery
- Availability of good quality tumor tissue sample for biomarker analysis
- Adequate blood counts and organ function within 14 days prior to treatment
- Ability and willingness to comply with study visits and procedures
- Negative pregnancy test within 7 days prior to randomization for women of childbearing potential
- Agreement to use highly effective contraception during and after the study as specified
- Ability to swallow oral medication
You will not qualify if you...
- Inoperable locally advanced or inflammatory breast cancer
- Metastatic (stage IV) breast cancer
- Bilateral or multicentric invasive breast cancer at diagnosis
- Need for immediate neoadjuvant chemotherapy or surgery
- Prior sentinel lymph node biopsy or tumor excisional biopsy before study treatment
- Malignancy within 3 years except certain treated non-melanoma skin or in situ cancers
- Use of prohibited medications or strong CYP3A4 modulators prior to treatment
- Vaccination within 7 days before randomization
- Prior treatment for current breast cancer including chemotherapy, endocrine, targeted, or radiation therapies
- Major surgery or significant trauma within 28 days prior to randomization
- Uncontrolled or significant cardiac conditions within 6 months prior to enrollment
- Liver impairment above Child-Pugh Class A
- Recent or active coagulopathy or thrombotic events within specified timeframes
- Known allergy to study drugs or excipients
- Conditions impairing oral medication use or absorption
- Significant comorbidities interfering with study participation
- Recent hormonal treatments ended less than 12 months prior, or natural products with progestins less than 14 days prior
- Use of interfering prescription medications within 1 month
- Pregnancy, breastfeeding, or intent to become pregnant during the study
AI-Screening
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Trial Site Locations
Total: 15 locations
1
ICO Badalona
Badalona, Barcelona, Spain
Actively Recruiting
2
ICO Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Actively Recruiting
3
Hospital Universitari Arnau de Vilanova de Lleida
Vilanova, Lleida, Spain
Actively Recruiting
4
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Actively Recruiting
5
Hospital Universitario de Badajoz
Badajoz, Spain
Actively Recruiting
6
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
7
Hospital Clinic de Barcelona
Barcelona, Spain
Actively Recruiting
8
Complejo Hospitalario San Pedro de Alcántara
Cáceres, Spain, 10003
Actively Recruiting
9
HM Sanchinarro (CIOCC)
Madrid, Spain
Actively Recruiting
10
Hospital Universitario 12 de Octubre
Madrid, Spain
Actively Recruiting
11
Hospital Universitario Central de Asturias
Oviedo, Spain
Actively Recruiting
12
Hospital Universitari Son Espases
Palma de Mallorca, Spain
Actively Recruiting
13
Complejo Hospitalario de Navarra
Pamplona, Spain
Actively Recruiting
14
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, Spain
Actively Recruiting
15
Hospital Clínico de Valencia
Valencia, Spain
Actively Recruiting
Research Team
S
Sara Cano, PhD
CONTACT
J
Juan M Ferrero, PharmD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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