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Breast CancerPhase 2SOLTI-2104NCT05982093

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

A Phase 2 study testing Elacestrant, Triptorelin and Tamoxifen 20 mg in people with Breast Cancer and HER2-negative Breast Cancer, run by SOLTI Breast Cancer Research Group at 15 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 35 years and older, women only
What is being tested?
Elacestrant, Triptorelin and Tamoxifen 20 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
15 sitesSpain
Study dates
3 Feb 2023to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Ki67 expression ≥ 10% and ≤ 35% by local assessment
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Breast cancer eligible for primary surgery.
  • Availability of pre-treatment tumor tissue sample of FFPE tumor block from primary tumor for biomarker analysis. The tumor tissue should be of good quality based on total and viable tumor content and must be evaluated centrally for quality prior to enrollment. Archival tumor tissue or ex professo biopsy are acceptable.
  • Adequate hematologic and organ function within 14 days before the first study treatment on Day 1, defined by the following:
  • Neutrophils (ANC ≥1.000/μL).
  • Hemoglobin ≥ 9.0 g/dL (with no need for transfusions).
  • Platelet count ≥ 75. 000/μL.
  • Serum creatinine ≤1.5 mg/dL or calculated creatinine clearance ≥30 mL/min (Cockcroft-Gault Equation)
  • International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN and activated partial thromboplastin time (aPTT) within therapeutic range.
  • Note: Subjects who are receiving anticoagulation treatment which is monitored by INR (eg, warfarin) may be allowed to participate if they have a stable INR (ie, within therapeutic range) for at least 28 days prior to the first dose of study drug, in the absence of any exclusionary medical conditions, and provided that elacestrant would be appropriate therapy for the subject
  • Potassium, total Calcium (corrected for serum albumin), and sodium NCI CTCAE v5.0 Grade ≤ 1.
  • Alanine aminotransferase (ALT) ≤ 3x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) ≤ 3x ULN
  • Total bilirubin ≤ ULN or total bilirubin ≤ 1.5x ULN with direct bilirubin ≤ ULN of the laboratory in subjects with documented Gilbert's Syndrome
  • Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.
  • Women of childbearing potential (CBP), defined as all women physiologically capable of becoming pregnant, must have confirmed negative serum pregnancy test within 7 days prior to randomization.
  • Female subjects must not donate, or retrieve for their own use, oocytes from the time of screening and throughout the study treatment period, and for at least 120 days after the time of final study drug administration.
  • Women of CBP must be willing to use highly effective methods of contraception. Contraception must continue during the trial treatment and after stopping the treatment received according to protocol. Highly effective contraception methods include:
  • Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
  • Placement of a non-hormonal intrauterine device (IUD). Notes: Use of oral (estrogen and progesterone), transdermal, injected, implanted, hormone containing intrauterine system, or any other hormonal methods of contraception is not allowed in this trial. Women are considered of CBP unless: they have had ≥ 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e., age-appropriate history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least four weeks prior to randomization. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment, she will be considered not of CBP. After the end of trial treatment, patients should use effective contraception at least until 28 days after therapy discontinuation.
  • Patients must have the ability to swallow oral medication.

Who cannot join

  • 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.
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  • 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.
  • Any of the following within 6 months before enrollment: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE v5.0 Grade ≥ 2, prolonged QTcF ≥ Grade 2 (i.e., > 480 msec), uncontrolled atrial fibrillation of any grade, coronary/peripheral artery bypass graft, heart failure ≥ Class II as defined by the New York Heart Association guidelines, or cerebrovascular accident including transient ischemic attack.
  • Child-Pugh Score greater than Class A (i.e., score >6)
  • Coagulopathy or any history of coagulopathy within the past 6 months, including history of deep vein thrombosis or pulmonary embolism. However, subjects with the following conditions will be allowed to participate:
  • Adequately treated catheter-related venous thrombosis occurring >28 days prior to the first dose of study drug
  • Treatment with an anticoagulant, e.g., warfarin or heparin, for a thrombotic event occurring > 6 months before enrollment, or for an otherwise stable and allowed medical condition (eg, well controlled atrial fibrillation), provided dose and coagulation parameters (as defined by local standard of care) are in therapeutic range prior to the first dose of study drug and provided that an AI would be an appropriate therapy for the subject
  • Known hypersensitivity to any of the study drugs, including excipients.
  • Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications such as: uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction/motility disorder, malabsorption syndrome, or prior gastric bypass.
  • History of or clinical evidence of significant co-morbidities that, in the judgment of the investigator, may interfere with the conduction of the study, the evaluation of response, or with informed consent.
  • Previous hormonal treatments for other indications such as osteoporosis, breast cancer prevention, hormonal substitutive therapy, such as raloxifene, tamoxifen, estrogen, progestins must have ended at least 12 months prior to trial registration. If a patient is on natural products known to contain progestins, they must be stopped 14 days prior to beginning study treatment.
  • Used any prescription medication during the prior 1 month that the investigator judge is likely to interfere with the study or to pose an additional risk to the patient in participating.
  • Female subject who is pregnant or breastfeeding or intends to become pregnant during the study.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sara Cano, PhD contact

+ 34 933 436 302

info@gruposolti.org

Juan M Ferrero, PharmD contact

+ 34 933 436 302

info@gruposolti.org

15 sites in 1 country

Spain15 sites, 15 recruiting

  • Hospital Universitario de Badajoz

    Badajoz

    Alba González-Haba

    Recruiting

  • ICO Badalona

    Badalona, Barcelona

    Eudald Felip

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Meritxell Bellet

    Meritxell Bellet

    Recruiting

  • Hospital Clinic de Barcelona

    Barcelona

    Maria Vidal, MD

    Recruiting

  • Complejo Hospitalario San Pedro de Alcántara

    Cáceres, 10003

    Santiago González, MD

    Recruiting

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, Murcia

    Ana Pérez, info@gruposolti.org

    Pilar Sánchez

    Recruiting

  • ICO Hospitalet

    L'Hospitalet de Llobregat, Barcelona

    Verónica Obadia

    Recruiting

  • HM Sanchinarro (CIOCC)

    Madrid

    Patricia Cortés

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid

    Pablo Tolosa, MD

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo

    Paula García Tejido

    Recruiting

  • Hospital Universitari Son Espases

    Palma de Mallorca

    Antonia Perelló

    Recruiting

  • Complejo Hospitalario de Navarra

    Pamplona

    Susana De la Cruz

    Recruiting

  • Hospital Universitari General de Catalunya

    Sant Cugat del Vallès

    Vanesa Ortega

    Recruiting

  • Hospital Clínico de Valencia

    Valencia

    Cristina Hernando, MD

    Recruiting

  • Hospital Universitari Arnau de Vilanova de Lleida

    Vilanova, Lleida

    Serafín Morales

    Recruiting

Other trials in Spain

About this study

Official title: A Phase 2 Randomized Pre-operative,Window of Opportunity Trial Investigating the Effect of Elacestrant With/Without Triptorelin in Premenopausal Patients With HR+/HER2- Breast Cancer - SOLTI-2104-PremiÈRe Trial.

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.

Read the detailed description

PremiÈRe Part A and Part B are parallel, non-comparative, two-arm, randomized 1:1, open-label, multicenter, exploratory trials designed to evaluate the biological activity of elacestrant in premenopausal women with primary operable HR+/HER2- BC.

Eligible patients must have histologically confirmed, operable, HR+/HER2-invasive breast cancer >1 cm, with a Ki67 between 10-35%, be treatment-naïve, and meet all other inclusion and exclusion criteria. An FFPE tumor sample of sufficient quality must be available, if not, patients must agree to undergo a re-biopsy.

In Part A, patients are randomized 1:1 to receive one of the following regimens:

  • Elacestrant arm: 400 mg orally once daily for 30 (+7) days.
  • Elacestrant + triptorelin arm: same elacestrant schedule plus triptorelin 3.75 mg on days 1 and 29.

In Part B, patients are randomized 1:1 to receive one of the following regimens:

  • Elacestrant arm: 400 mg orally once daily for 30 (+7) days
  • Tamoxifen arm: 20 mg orally once daily for 30 (+7) days.

Randomization is stratified by PAM50 intrinsic subtype (Luminal A vs non-Luminal A), determined by research-based molecular profiling.

During the treatment period, blood samples will be collected for the isolation of plasma and serum at baseline, Day 14, Day 28, and post-treatment. In PremiÈRe Part B only, optional transvaginal ultrasound (TVUS) assessments may be performed at baseline, Day 28, and at the End of Study visit, to explore changes in ovarian and uterine parameters.

Following treatment, breast and axillary surgery will be performed according to local practice procedures. Pre-surgical sentinel lymph node biopsy (SLNB) is not allowed. Surgical specimens (or mandatory biopsy samples if no surgery is planned) will be collected for analysis.

A post-surgery visit will occur within 28 ± 14 days and will mark the end of active follow-up.

Being tested
Elacestrant, Triptorelin, Tamoxifen 20 mg
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElacestrantDrug

    Also called Orserdu

    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).

  • TriptorelinDrug

    Also called Orserdu

    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 mgDrug

    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 groups in NCT05982093
Study groupRoleWhat they receive
ElacestrantExperimentalwithout ovarian function suppression
Receives: Drug: Elacestrant
Elacestrant + TriptorelinActive comparatorwith ovarian function suppression
Receives: Drug: Elacestrant; Drug: Triptorelin
TamoxifenActive comparatormonotherapy
Receives: Drug: Tamoxifen 20 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: After 30 days (+7 days) of therapy

Secondary outcomes (8)

  1. 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.

    Rate of CCCA determined by central assessment by IHC Ki67 (% Ki67 ≤ 2.7%) after short-term elacestrant therapy with or without OFS for patients Luminal A and Non-Luminal A.

    Measured: After 30 days (+7 days) of therapy

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

    Mean change in Ki67 measured by IHC Ki67 expression between pre- and post-treatment samples. - Differences in differential expression of proliferative genes

    Measured: After 30 days (+7 days) of therapy

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

    Proportion of patients switching subtype between pre- and post-treatment samples

    Measured: After 30 days (+7 days) of therapy

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

    Mean change in measured by Ki67 expression between pre- and post-treatment samples and CCCA rate determined by Ki67 ≤ 2.7% between pre- and post-treatment samples of elacestrant therapy with or without OFS

    Measured: After 30 days (+7 days) of therapy

  5. To evaluate levels of E2 in blood.

    Mean change of E2 levels between pre- and during treatment (D14) and pre-surgery samples

    Measured: After 14 days (+2 days) of therapy

  6. To evaluate levels of FSH in blood.

    Mean change of FSH levels between pre- and during treatment (D14) and pre-surgery samples

    Measured: After 14 days (+2 days) of elacestrant therapy

  7. To evaluate the safety of the treatments when administered in pre-menopausal patient population.

    Incidence and severity of adverse events, with severity, determined according to NCI CTAE v.5.0.

    Measured: Until End of Study Visit (7-28 days after surgery)]

  8. To evaluate the tolerability of the treatments when administered in pre-menopausal patient population.

    Change from baseline in targeted clinical laboratory test results, including ECGs

    Measured: Until End of Study Visit (7-28 days after surgery)]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2023
  2. Study start3 Feb 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
parallel, non-comparative, two-arm, randomized 1:1, open-label, multicenter, exploratory window of opportunity study
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05982093
Sponsor's protocol ID
PREMIERE (SOLTI-2104)
Acronym
SOLTI-2104
Status last verified
Apr 2026
First submitted
6 Jul 2023
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elacestrant, Triptorelin and Tamoxifen 20 mg in people with Breast Cancer and HER2-negative Breast Cancer, run by SOLTI Breast Cancer Research Group at 15 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 37 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sara Cano, PhD (+ 34 933 436 302, info@gruposolti.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05982093.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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