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

NCT05982093 | Recruiting Phase 2

• 1 other identifier: PREMIERE (SOLTI-2104)
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 15

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• To evaluate the biological activity of elacestrant with or without OFS in premenopausal women with ER+/HER2- operable EBC

  Rate of CCCA determined by central assessment by IHC Ki67 (% Ki67 ≤ 2.7%) after 4 weeks of therapy.

  After 30 days (+7 days) of therapy

Secondary Outcomes (8)

• To evaluate the biological activity of elacestrant with or without OFS in premenopausal women with ER+/HER2- operable EBC according to baseline research-based PAM50 subtype.

  After 30 days (+7 days) of therapy

• To evaluate the antiproliferative activity of elacestrant with or without OFS after -treatment

  After 30 days (+7 days) of therapy

• To identify changes in the research-based PAM50 subtypes pre- and post-treatment samples after treatment

  After 30 days (+7 days) of therapy

• To evaluate the effect of optimal and suboptimal OFS (E2 level greater than 2.72 pg/mL) in CCCA

  After 30 days (+7 days) of therapy

• To evaluate levels of E2 in blood.

  After 14 days (+2 days) of therapy

Study Arms (3)

Elacestrant

EXPERIMENTAL

without ovarian function suppression

Drug: Elacestrant

Elacestrant + Triptorelin

ACTIVE COMPARATOR

with ovarian function suppression

Drug: Elacestrant; Drug: Triptorelin

Tamoxifen

ACTIVE COMPARATOR

monotherapy

Drug: Tamoxifen 20 mg

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).

Also known as: Orserdu

Elacestrant; Elacestrant + Triptorelin

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.

Also known as: Orserdu

Elacestrant + Triptorelin

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).

Tamoxifen

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent must be obtained prior to any trial-specific procedure.
• Female patients who are at least 35 years of age on the day of signing informed consent.
• Patient is premenopausal at the time of study entry
• Premenopausal status is defined as either:
• Patient had last menstrual period within the last 6 months. OR
• Plasma estradiol and FSH in the premenopausal range, according to local laboratory definition.
• Note: Patients who have undergone bilateral oophorectomy are not eligible.
• Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast untreated and recently diagnosed, with all the following characteristics:
• Stage I to stage IIB operable breast cancer (7th Edition of the AJCC). Note: Axillary lymph node status must be assessed by fine needle biopsy or core biopsy. This procedure at screening will be omitted if there is no suspicion for positive axillary lymph node(s) radiographically or if a pathological report of suspicious lymph nodes of the results of a fine needle biopsy or core biopsy is available prior to the screening period.
• Absence of distant metastasis (i.e., M0) as determined by institutional practice.
• At least 1 lesion that can be accurately and serially measured in at least 1 dimension and for which the longest diameter is ≥ 10 mm as measured by magnetic resonance imaging (MRI) or ultrasound (US).
• In the case of a multifocal tumor, the largest lesion must be ≥ 10 mm and designated the "target" lesion for all subsequent tumor evaluations. All biopsied tumors had to be ER+HER2-negative
• ER-positive with expression higher than 10% and HER2-negative tumor
• HER2 negativity is defined as either of the following: Immunohistochemistry (IHC) 0, IHC 1+ or IHC2+/in situ hybridization (ISH) negative as per most recent American Society of Clinical Oncology (ASCO)-College of American Pathologists Guideline (CAP) guideline according to the local laboratory as determined on the most recently analyzed tissue sample.
• Documentation of ER positive tumor with ≥ 10% staining by immunohistochemistry of cells as per most recent ASCO-CAP guideline according to the local laboratory determined on the most recently analyzed tissue sample, with or without progesterone receptor positivity.

You may not qualify if:

• Inoperable locally advanced or inflammatory breast cancer (any stage III).
• Metastatic (Stage IV) breast cancer.
• Synchronous invasive bilateral or multicentric breast cancer.
• Patients requiring immediate neoadjuvant chemotherapy or immediate surgical intervention.
• Patients who have undergone sentinel lymph node biopsy or tumor excisional biopsy prior to study treatment.
• Prior malignancy within 3 years prior to randomization, except curatively treated non-melanoma skin cancer, in situ cancer or adequately and curatively treated Stage I or II cancer from which the patient is currently in complete remission.
• Patients currently on following medications, which cannot be interrupted 7 days prior treatment start:
• Any prohibited medication as per decapeptyl (triptorelin) label
• Strong inhibitors of CYP3A4, including grapefruit, grapefruit hybrids, pummelos, starfruit and Seville oranges
• Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 (Refer to http://medicine.iupui.edu/clinpharm/ddis/) within 5 half-life of the drug prior to initiating trial therapy
• Herbal preparations/medications. These include, but are not limited to, St. John's wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng within 5 half-life of the drug prior to initiating trial therapy
• Vaccination, including but not limited to vaccination against COVID-19, during the 7 days prior to randomization.
• Any treatment, local or systemic, including prior chemotherapy, ET, targeted therapy, and/or radiation therapy for the currently diagnosed BC prior to enrollment.
• Major surgical procedure or significant traumatic injury within 28 days prior to randomization.
• Assessment by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Sponsors & Collaborators

• SOLTI Breast Cancer Research Group: lead

Study Sites (15)

ICO Badalona

Badalona, Barcelona, Spain

RECRUITING

ICO Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

RECRUITING

Hospital Universitari Arnau de Vilanova de Lleida

Vilanova, Lleida, Spain

RECRUITING

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

RECRUITING

Hospital Universitario de Badajoz

Badajoz, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, Spain

RECRUITING

Complejo Hospitalario San Pedro de Alcántara

Cáceres, 10003, Spain

RECRUITING

HM Sanchinarro (CIOCC)

Madrid, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Spain

RECRUITING

Hospital Universitari Son Espases

Palma de Mallorca, Spain

RECRUITING

Complejo Hospitalario de Navarra

Pamplona, Spain

RECRUITING

Hospital Universitari General de Catalunya

Sant Cugat del Vallès, Spain

RECRUITING

Hospital Clínico de Valencia

Valencia, Spain

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

elacestrant; Triptorelin Pamoate; Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Sara Cano, PhD

CONTACT

+ 34 933 436 302; info@gruposolti.org

Juan M Ferrero, PharmD

CONTACT

+ 34 933 436 302; info@gruposolti.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: parallel, non-comparative, two-arm, randomized 1:1, open-label, multicenter, exploratory window of opportunity study

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: August 8, 2023
• Study Start: February 3, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

ES (15)